SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

For the month of May 2018

Commission File Number 001-37410

ESSA Pharma Inc.

(Translation of registrant’s name into English)

Suite 720, 999 West Broadway, Vancouver, British Columbia, Canada, V5Z 1K5

(Address of principal executive offices)

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 the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

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

 

 

 

 
 

 

 

EXHIBITS INCLUDED AS PART OF THIS REPORT

 

     
Exhibit(s)    
     
99.1  

Condensed Consolidated Interim Financial Statements for the Six Months Ended March 31, 2018 and 2017

99.2   Management’s Discussion and Analysis for the Six Months Ended March 31, 2018 and 2017
99.3   Certification of Interim Filing: CEO
99.4   Certification of Interim Filing: CFO
99.5   News Release Dated May 14, 2018: ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Second Quarter Ended March 31, 2018

 

 
 

 

 

 

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.

 

             
   

E SSA P HARMA I NC .

    (Registrant)
     
Date: May 14, 2018   By:  

/ S / D AVID W OOD

   

Name:

Title:

 

David Wood

Chief Financial Officer

 

Exhibit 99.1

 

 

 

 

 

 

 

 

 

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

 

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

 

 

 

 

 

 
 

 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(Unaudited)

(Expressed in United States dollars)

AS AT

         
   

March 31,

2018

 

September 30,

2017

         
ASSETS                
                 
Current                
Cash   $ 21,691,588     $ 3,957,185  
Receivables     58,527       29,475  
Prepaids (Note 4)     266,703       1,072,103  
                 
      22,016,818       5,058,763  
                 
Equipment (Note 5)     89,088       99,882  
Intangible assets (Note 6)     228,177       237,326  
Deferred financing costs (Note 9)     —         211,073  
                 
                 
Total assets   $ 22,334,083     $ 5,607,044  
                 
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIENCY)                
                 
Current                
Accounts payable and accrued liabilities   $ 1,379,575     $ 1,641,103  
Current portion of long-term debt (Note 7)     2,767,123       2,026,588  
Income tax payable     15,145       109,521  
                 
      4,161,843       3,777,212  
                 
Long-term debt (Note 7)     4,724,911       5,933,092  
Derivative liabilities (Note 8)     72,930       170,743  
                 
Total liabilities     8,959,684       9,881,047  
                 
Shareholders' equity (deficiency)                
Share capital (Note 9)     40,200,688       25,980,117  
Reserves (Note 10)     14,462,733       4,562,005  
Accumulated other comprehensive loss     (2,076,479 )     (2,076,479 )
Deficit     (39,212,543 )     (32,739,646 )
                 
      13,374,399       (4,274,003 )
                 
Total liabilities and shareholders’ equity (deficiency)   $ 22,334,083     $ 5,607,044  

 

Nature and continuance of operations (Note 1)

Commitments (Note 16)

Subsequent event (Note 18)

 

On behalf of the Board on May 14, 2018  
       
“David R. Parkinson” Director “Franklin Berger” Director
       

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

 

 
 

 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(Unaudited)

(Expressed in United States dollars)

 

                 
   

Three months

ended

March 31,

2018

 

Three months

ended

March 31,

2017

 

Six months

ended

March 31,

2018

 

Six months

ended

March 31,

2017

                 
OPERATING EXPENSES                                
Research and development, net of recoveries (Note 17)   $ 1,989,107     $ 2,548,761     $ 2,958,704     $ 1,640,268  
Financing costs     236,843       218,386       481,653       311,476  
General and administration (Note 17)     2,179,717       1,363,493       3,138,092       2,733,312  
                                 
Total operating expenses     (4,405,667 )     (4,130,640 )     (6,578,449 )     (4,685,056 )
                                 
Foreign exchange     13,461       578       7,739       6,984  
Gain (loss) on derivative liability (Note 8)     9,250       (3,480,517 )     97,813       (1,486,142 )
                                 
Net loss for the period before taxes     (4,382,956 )     (7,610,579 )     (6,472,897 )     (6,164,214 )
                                 
Income tax recovery (expense)     —         —         —         18,097  
                                 
Net loss and comprehensive loss for the period   $ (4,382,956 )   $ (7,610,579 )   $ (6,472,897 )   $ (6,146,117 )
                                 
Basic and diluted loss per common share   $ (0.83 )   $ (5.23 )   $ (2.70 )   $ (4.22 )
                                 

Weighted average number of common shares

outstanding

    5,287,605       1,454,844       2,400,097       1,454,844  

 

 

 

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

 

 
 

 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31

         
    2018   2017
         
         
CASH FLOWS FROM OPERATING ACTIVITIES                
Loss for the period   $ (6,472,897 )   $ (6,146,117 )
Items not affecting cash:                
Amortization     19,943       23,073  
(Gain) loss on derivative liability     (97,813 )     1,486,142  
Finance expense     481,653       311,476  
Product development and relocation grant     —         (5,192,799 )
Unrealized foreign exchange     3,347       (4,728 )
Share-based payments (Note 10)     472,507       575,052  
                 
Changes in non-cash working capital items:                
Receivables     (27,884 )     (83,782 )
Prepaid expenses     805,400       358,243  
Accounts payable and accrued liabilities     (267,898 )     (587,483 )
Income tax payable     (94,376 )     —    
                 
Net cash used in operating activities     (5,178,018 )     (9,260,923 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
Product development and relocation grant     —         5,192,799  
Proceeds on financing     26,040,000       —    
Share issuance costs     (2,180,135 )     —    
Proceeds on loan advance     —         8,000,000  
Financing costs     —         (156,895 )
Loan principal repaid     (657,340 )     —    
Interest paid     (291,959 )     (147,222 )
                 
Net cash provided by financing activities     22,910,566       12,888,682  
                 
Effect of foreign exchange on cash     1,855       5,900  
                 
Change in cash for the period     17,734,403       3,633,659  
                 
Cash, beginning of period     3,957,185       8,985,095  
                 
Cash, end of period   $ 21,691,588     $ 12,618,754  

 

         Supplemental Cash Flow Information (Note 11)

 

 

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

 

 
 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)

(Unaudited)

(Expressed in United States dollars)

 

                         
            Reserves            
    Number of shares   Share capital   Share-based payments   Warrants   Cumulative translation adjustment   Deficit   Total
                             
Balance, September 30, 2016     1,454,848     $ 25,974,742     $ 3,496,221     $ 309,293     $ (2,076,479 )   $ (28,240,634 )   $ (536,857 )
Share-based payments     —         —         575,052       —         —         —         575,052  
Loss for the period     —         —         —         —         —         (6,146,117 )     (6,146,117 )
                                                         
Balance, March 31, 2017     1,454,848     $ 25,974,742     $ 4,071,273     $ 309,293     $ (2,076,479 )   $ (34,386,751 )   $ (6,107,922 )
Options exercised     250       5,375       (2,436 )     —         —         —         2,939  
Share-based payments     —         —         183,875       —         —         —         183,875  
Income for the period     —         —         —         —         —         1,647,105       1,647,105  
                                                         
Balance, September 30, 2017     1,455,098     $ 25,980,117     $ 4,252,712     $ 309,293     $ (2,076,479 )   $ (32,739,646 )   $ (4,274,003 )
Financing     4,321,000       17,284,000       —         8,756,000       —         —         26,040,000  
Share issuance costs     —         (3,063,429 )     —         672,221       —         —         (2,391,208 )
Share-based payments     —         —         472,507       —         —         —         472,507  
Loss for the period     —         —         —         —         —         (6,472,897 )     (6,472,897 )
                                                         
Balance, March 31, 2018     5,776,098     $ 40,200,688     $ 4,725,219     $ 9,737,514     $ (2,076,479 )   $ (39,212,543 )   $ 13,374,399  

 

 

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

 

 
 

 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

1.       NATURE AND CONTINUANCE OF OPERATIONS

 

Nature of Operations

 

ESSA Pharma Inc. (the “Company”) was incorporated under the laws of the Province of British Columbia on January 6, 2009. The Company’s head office address is Suite 720 - 999 West Broadway, Vancouver, BC, V5Z 1K5. The registered and records office address is the 26 th Floor at 595 Burrard Street, Three Bentall Centre, Vancouver, BC, V7X 1L3. The Company is listed on the NASDAQ Capital Market (“NASDAQ”) under the symbol “EPIX”, and on the Toronto Venture Exchange (“TSX-V”) under the symbol “EPI”.

 

The Company is focused on the development of small molecule drugs for the treatment of prostate cancer. The Company has acquired a license to certain patents (the “NTD Technology”) which were the joint property of the British Columbia Cancer Agency and the University of British Columbia. As at March 31, 2018, no products are in commercial production or use. From November 2015 until September 2017, the Company’s primary activity was the Phase I clinical development of clinical candidate EPI-506. On September 11, 2017, the Company announced its decision to discontinue further clinical development of EPI-506 and to implement a corporate restructuring plan to focus research and development resources on its next-generation compounds. The restructuring included a decrease in headcount and reduction of operational expenditures related to the clinical program.

 

Share Consolidation

 

Effective April 25, 2018, the Company consolidated its issued and outstanding common shares on the basis of one post-consolidation share for 20 pre-consolidation shares. Unless otherwise stated, all share and per share amounts have been restated retrospectively to reflect this share consolidation.

 

Going Concern

 

These financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) assuming the Company will continue on a going-concern basis. The Company has incurred losses and negative operating cash flows since inception. The Company incurred a net loss of $6,472,897 during the six months ended March 31, 2018 and has an accumulated deficit of $39,212,543. The ability of the Company to continue as a going concern in the long-term depends upon its ability to develop profitable operations and to continue to raise adequate financing.  As at March 31, 2018, the Company has not advanced its research into a commercially viable product. The Company’s continuation as a going concern is dependent upon the successful development of its NTD Technology to a commercial standard.

 

During the six months ended March 31, 2018, the Company completed a financing of $26,040,000 in gross proceeds (Note 9). Management believes that this financing will provide adequate funding to complete its planned programs over the next twelve months.

 

2.       BASIS OF PRESENTATION

 

Statement of Compliance

 

These condensed consolidated interim financial statements, including comparatives, have been prepared in accordance with International Accounting Standards (“IAS”) 34 ‘Interim Financial Reporting’ (“IAS 34”) using accounting policies consistent with International Financial Reporting Standards (“IFRS”) issued by the International Accounting Standards Board (“IASB”) and Interpretations of the International Financial Reporting Interpretations Committee (“IFRIC”).

 

The condensed consolidated interim financial statements do not include all the information and disclosures required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the year ended September 30, 2017.

 

 
 

 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

2.       BASIS OF PRESENTATION (cont’d...)

 

Basis of Presentation

 

The condensed consolidated interim financial statements have been prepared on a historical cost basis except for certain financial assets measured at fair value. In addition, these condensed consolidated interim financial statements have been prepared using the accrual basis of accounting, except for cash flow information.

 

All amounts expressed in these condensed consolidated interim financial statements and the accompanying notes are expressed in United States dollars, except per share data and where otherwise indicated. References to “$” are to United States dollars and references to “C$” are to Canadian dollars.

 

Basis of Consolidation

 

The condensed consolidated interim financial statements comprise the accounts of ESSA Pharma Inc., the parent company, and its wholly-owned subsidiary, ESSA Pharmaceuticals Corp., after the elimination of all material intercompany balances and transactions.

 

Subsidiaries

 

Subsidiaries are all entities over which the Company has exposure to variable returns from its involvement and has the ability to use power over the investee to affect its returns. The existence and effect of potential voting rights that are currently exercisable or convertible are considered when assessing whether the Company controls another entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Company until the date on which control ceases.

 

The accounts of subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies. Inter-company transactions, balances and unrealized gains or losses on transactions are eliminated upon consolidation.

 

Functional and Presentation Currency

 

The functional currency of an entity is the currency of the primary economic environment in which the entity operates. From inception to January 1, 2016, the functional currency of the Company has been the Canadian dollar and its subsidiary’s the United States dollar. The functional currency determinations were conducted through an analysis of the consideration factors identified in IAS 21, The Effects of Changes in Foreign Exchange Rates . The financing completed in January 2016 and changes to the Company’s operations have resulted in a change to the currency in which the Company’s management conducts its operating, capital and financing decisions. Consequently, the functional currency of the Company became the US$ effective January 1, 2016.

 

These financial statements are presented in United States dollars. All financial information is expressed in United States dollars unless otherwise stated.

 

Estimates

 

The Company makes estimates and assumptions about the future that affect the reported amounts of assets and liabilities. Estimates and judgments are continually evaluated based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. In the future, actual results may differ from these estimates and assumptions.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

2.       BASIS OF PRESENTATION (cont’d...)

 

Estimates (cont’d...)

 

The effect of a change in an accounting estimate is recognized prospectively by including it in comprehensive income in the period of the change, if the change affects that period only, or in the period of the change and future periods, if the change affects both. Significant assumptions about the future and other sources of estimation uncertainty that management has made at the statement of financial position date, that could result in a material adjustment to the carrying amounts of assets and liabilities, in the event that actual results differ from assumptions that have been made, relate to the following key estimates:

 

Intangible Assets - impairment

 

The application of the Company’s accounting policy for intangible assets expenditures requires judgment in determining whether it is likely that future economic benefits will flow to the Company, which may be based on assumptions about future events or circumstances. Estimates and assumptions may change if new information becomes available. If, after expenditures are capitalized, information becomes available suggesting that the recovery of expenditures is unlikely, the amount capitalized is written off in profit or loss in the period the new information becomes available.

 

Following initial recognition, the Company carries the value of intangible assets at cost less accumulated amortization and any accumulated impairment losses. Amortization is recorded on a straight-line basis based upon management’s estimate of the useful life and residual value. The estimates are reviewed at least annually and are updated if expectations change as a result of technical obsolescence or legal and other limits to use. A change in the useful life or residual value will impact the reported carrying value of the intangible assets resulting in a change in related amortization expense.

 

Product development and relocation grant

 

Pursuant to the terms of the Company’s grant from the Cancer Prevention Research Institute of Texas (“CPRIT”), the Company must meet certain terms and conditions to qualify for the grant funding. The Company has assessed its performance relative to these terms as detailed in Note 16 and has judged that there is reasonable assurance the Company will meet the terms of the grant and qualify for the funding. The Company has therefore recognized in profit or loss, as recoveries of research and development expenditures, a portion of the grant that represents expenses the Company has incurred to date under the grant parameters. The expenses are subject to assessment by CPRIT for compliance with the grant regulations which may result in certain expenses being denied and incurred in a future period.

 

Long-term debt

 

The Company has made certain estimates regarding the expected timing of and value of cash flows with respect to long-term debt. The estimates will fluctuate in accordance with changes in interest rates and any prepayments made, should the Company elect to do so (Note 7).

 

Derivative financial instruments

 

Certain warrants are treated as derivative financial liabilities. The estimated fair value, based on the Black-Scholes model, is adjusted on a quarterly basis with gains or losses recognized in the statement of loss and comprehensive loss. The Black-Scholes model is based on significant assumptions such as volatility, dividend yield, expected term and liquidity discounts (Note 8).

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

  

 

2.       BASIS OF PRESENTATION (cont’d...)

 

Estimates (cont’d...)

 

Share-based payments and compensation

 

The Company has applied estimates with respect to the valuation of shares issued for non-cash consideration. Shares are valued at the fair value of the equity instruments granted at the date the Company receives the goods or services.

 

The Company measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. Estimating fair value for share-based payment transactions requires determining the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This estimate also requires determining the most appropriate inputs to the valuation model including the fair value of the underlying common shares, the expected life of the share option, volatility and dividend yield and making assumptions about them. The Company has made reference to prices quoted on the TSX, TSX-V and NASDAQ. The assumptions and models used for estimating fair value for share-based payment transactions are discussed in Note 10.

 

3.       SIGNIFICANT ACCOUNTING POLICIES

 

New standards not yet adopted

 

IFRS 9 Financial Instruments

 

IFRS 9 was issued by the IASB in October 2010. It incorporates revised requirements for the classification and measurement of financial liabilities and carrying over the existing derecognition requirements from IAS 39 Financial Instruments: recognition and measurement. The revised financial liability provisions maintain the existing amortized cost measurement basis for most liabilities. New requirements apply where an entity chooses to measure a liability at fair value through profit or loss - in these cases, the portion of the change in fair value related to changes in the entity's own credit risk is presented in other comprehensive income rather than within profit or loss. IFRS 9 is effective for annual periods beginning on or after January 1, 2018. IFRS 9 is not expected to have a significant impact on the Company’s condensed consolidated interim financial statements.

 

IFRS 15 Revenue from Contracts with Customers

 

IFRS 15 is a new standard to establish principles for reporting the nature, amount, timing, and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. It provides a single model in order to depict the transfer of promised goods or services to customers. IFRS 15 supersedes IAS 11, Construction Contracts, IAS 18, Revenue, IFRIC 13, Customer Loyalty Programs, IFRIC 15, Agreements for the Construction of Real Estate, IFRIC 18, Transfers of Assets from Customers, and SIC-31, Revenue - Barter Transactions involving Advertising Service. IFRS 15 is effective for annual periods beginning on or after January 1, 2018. IFRS 15 is not expected to have a significant impact on the Company’s financial statements.

 

IFRS 16 Leases

 

IFRS 16 is a new standard that sets out the principles for recognition, measurement, presentation, and disclosure of leases including guidance for both parties to a contract, the lessee and the lessor. The new standard eliminates the classification of leases as either operating or finance leases as is required by IAS 17 and instead introduces a single lessee accounting model. IFRS 16 is effective for annual periods beginning on or after January 1, 2019. The impact of IFRS 16 on the Company’s leases has not yet been determined.

 

 
 

 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

4.       PREPAID EXPENSES

 

         
   

March 31,

2018

 

September 30,

2017

         
Clinical program deposit   $ 45,133     $ 659,899  
Other deposits and prepaid expenses     221,570       412,204  
                 
Balance   $ 266,703     $ 1,072,103  

 

5.       EQUIPMENT

 

             
   

Furniture and

fixtures

 

Computer

equipment

  Total
             
Cost                        
Balance, September 30, 2016, 2017 and
             March 31, 2018
  $ 154,318     $ 43,359     $ 197,677  
                         
Accumulated Amortization                        
Balance, September 30, 2016   $ 49,594     $ 20,353     $ 69,947  
                Amortization expense     20,945       6,903       27,848  
                         
Balance, September 30, 2017     70,539       27,256       97,795  
                Amortization expense     8,378       2,416       10,794  
                         
Balance, March 31, 2018   $ 78,917     $ 29,672     $ 108,589  
                         
Net Book Value                        
Balance, September 30, 2017   $ 83,779     $ 16,103     $ 99,882  
Balance, March 31, 2018   $ 75,401     $ 13,687     $ 89,088  

 

Amortization expense has been recorded in “general and administrative expenses” in the statement of loss and comprehensive loss (Note 17).

 

6.       INTANGIBLE ASSETS

 

 

     

NTD

Technology

 
         
Cost        
Balance, September 30, 2016, 2017 and March 31, 2018   $ 361,284  
         
Accumulated Amortization    
Balance, September 30, 2016   $ 105,661  
            Amortization expense     18,297  
         
Balance, September 30, 2017   $ 123,958  
            Amortization expense     9,149  
         
Balance, March 31, 2018   $ 133,107  

 

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

6.       INTANGIBLE ASSETS (cont’d...)

 

 

     

NTD

Technology

 
         
Net Book Value        
Balance, September 30, 2017   $ 237,326  
Balance, March 31, 2018   $ 228,177  

 

 

Amortization expense has been recorded in “general and administrative expenses” in the statement of loss and comprehensive loss (Note 17).

 

The NTD Technology is held under a License Agreement signed in fiscal 2010. As consideration for the License Agreement, the Company issued common shares of the Company. The License Agreement contains an annual royalty as a percentage of annual net revenue and a percentage of any annual sublicensing revenue earned with respect to the NTD Technology. The License Agreement stipulates certain minimum advance royalty payments of C$85,000. In addition, there are certain milestone payments for the first compound, to be paid in stages as to C$50,000 at the start of a Phase II clinical trial, C$900,000 at the start of a Phase III clinical trial, C$1,450,000 at application for marketing approval, and with further milestone payments on the second and additional compounds.

 

7.       LONG-TERM DEBT

 

On November 18, 2016, Silicon Valley Bank (“SVB”) entered into a $10,000,000 capital term loan facility agreement (“SVB Term Loan”) with the Company. The Company has drawn down $8,000,000 from the SVB Term Loan. There was a conditional option to receive an additional $2,000,000 upon positive data for the Company’s Phase 1 clinical trial of EPI-506 and receipt of the third and final tranche of the CPRIT grant.

 

The SVB Term Loan bears an interest rate of the Wall Street Journal Prime Rate (“WSJ Prime Rate”) plus 3% per annum and will mature on September 1, 2020. The SVB Term Loan requires a final payment of 8.6% of the amount advanced (“Final Payment”), due upon the earlier of the maturity or termination of the SVB Term Loan. The Company was required to make interest only payments until December 31, 2017. The SVB Term Loan contains a voluntary prepayment option whereby the principal amount can be prepaid in whole, or in part, for a fixed fee if a prepayment is made on or before the second anniversary of the SVB Term Loan.

 

The SVB Term Loan is secured by a perfected first priority lien on all of the Company’s assets, with a negative pledge on the Company’s intellectual property. The SVB Term Loan is subject to standard events of default, including default in the event of a material adverse change. SVB may declare the Company to be in breach of the agreement in the event of a material adverse change, which has been defined to include a material impairment in the Company’s assets acting as collateral under the SVB Term Loan, a material adverse change in the business, operations, or condition (financial or otherwise) of the Company, or a material impairment of the prospect of repayment of any portion of its debt obligations. There are no financial covenants under the SVB Term Loan.

 

In connection with the $8,000,000 draw, the Company granted an aggregate of 7,477 warrants to SVB (the “SVB Warrants”), exercisable at a price of $42.80 per share for a period of seven years until November 18, 2023, with an initial fair value of $167,022, which has been recognized as a derivative liability (Note 8). The Company incurred total additional transaction costs of $220,898 related to the SVB Term Loan and First Amendment. The transaction costs and Final Payment are being amortized into profit and loss over the estimated term of the facility, being the legal term, at an effective interest rate of 11.97%.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

7.       LONG-TERM DEBT (cont’d...)

 

     
   

SVB Term

Loan

     
Balance, September 30, 2016   $ —    
Loan advance     8,000,000  
Transaction costs     (387,959 )
Interest paid     (436,944 )
Accretion     784,583  
         
Balance, September 30, 2017   $ 7,959,680  
Principal repaid     (657,340 )
Interest paid     (291,959 )
Accretion     481,653  
         
Balance, March 31, 2018   $ 7,492,034  
         
Current portion   $ 2,767,123  
Long-term portion   $ 4,724,911  

 

8.       DERIVATIVE LIABILITIES

 

Broker Warrants Denominated in Foreign Currency

 

In accordance with IFRS, an obligation to issue shares for a price that is not fixed in the Company’s functional currency, and that does not qualify as a rights offering, must be classified as a derivative liability and measured at fair value with changes recognized in the statement of loss and comprehensive loss as they arise. The derivative liability was designated as a financial liability carried at fair value through profit and loss.

 

In April 2014, in connection with the issuance of a convertible debenture for $1,000,000, the Company issued 1,250 broker warrants valued at $14,935 (C$16,394), each exercisable into one common share at a price of C$40.00 for a period of five years (Note 10). The warrants were valued using the Black-Scholes model with a risk-free interest rate of 1.63%, term of 5 years, volatility of 80% and dividend rate of 0%.

 

As at March 31, 2018, the derivative liability had a fair value of $21 (September 30, 2017 - $206). The Company has recorded the resulting change in fair value of $185 (2017 - $3,570) in the statement of loss and comprehensive loss.

 

2016 Warrants

 

In January 2016, the Company completed a private placement of 227,273 units of the Company at $66.00 per unit (“Unit”) for gross proceeds of $14,999,992. Each Unit consisted of one pre-consolidation common share of the Company, one pre-consolidation 7-year cash and cashless exercise warrant (the “7-Year Warrants”), and one half of one pre-consolidation 2-year cash exercise warrant (the “2-Year Warrants”). The 7-Year Warrants and 2-Year Warrants have an exercise price of $66.00 per common share (collectively, the “2016 Warrants”). The holders of the 7-Year Warrants may elect, in lieu of exercising the 7-Year Warrants for cash, a cashless exercise option, in whole or in part, to receive common shares equal to the fair value of the 7-Year Warrants based on the number of 7-Year Warrants to be exercised multiplied by a ten-day weighted average market price less the exercise price with the difference divided by the weighted average market price. If a warrant holder exercises this option, there will be variability in the number of shares issued per 7-Year Warrant.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

8.       DERIVATIVE LIABILITIES (cont’d...)

 

2016 Warrants (cont’d...)

 

Additionally, the 2016 Warrants contain provisions which may require the Company to redeem the 2016 Warrants, at the option of the holder, in the event of a major transaction, such as a change of control or sale of the Company’s assets (“Major Transaction”). The redemption value would be subject to a Black-Scholes valuation at the time of exercise. In the event the consideration for a Major Transaction payable to the common shareholders is in cash, in whole or in part, the redemption of the 2016 Warrants would be made in cash pro-rata to the composition of the consideration. The potential for a cash settlement for the 2016 Warrants, in accordance with IFRS, requires the 2016 Warrants to be treated as financial liabilities measured at fair value through profit or loss.

 

The 2016 Warrants are not traded in an active market. A liquidity discount of 20% has been applied to the per warrant fair value to account for the lack of marketability of the instruments. On January 13, 2018, the 2-Year Warrants expired unexercised. As at March 31, 2018, the 7-Year Warrants derivative liability had a fair value of $68,328 (September 30, 2017 - $160,262). The Company has recorded the resulting change in fair value of $91,934 (2017 - $1,482,572) in the statement of loss and comprehensive loss.

 

SVB Warrants

 

In connection with the $8,000,000 draw on the SVB Term Loan (Note 7), the Company granted an aggregate of 7,477 warrants to SVB (the “ SVB Warrants ”), exercisable at a price of $42.80 per share for a period of seven years until November 18, 2023. The holders of the SVB Warrants may elect, in lieu of exercising the SVB Warrants for cash, a cashless exercise option, in whole or in part, to receive common shares equal to the fair value of the SVB Warrants based on the number of SVB Warrants to be exercised multiplied by a five-day weighted average market price less the exercise price with the difference divided by the weighted average market price. If a warrant holder exercises this option, there will be variability in the number of shares issued per SVB Warrant.

 

Additionally, the SVB Warrants contain provisions which require the Company to redeem the SVB Warrants, on a cashless basis, at the option of the holder, in the event of a major transaction, such as a change of control or sale of the Company’s assets (“Acquisition”) where the Company’s shareholders receive cash or shares or a combination thereof, and the five-day weighted average market price is greater than the exercise price.

 

On issuance of the SVB Warrants, the Company recorded a derivative liability of $167,022 using the Black-Scholes model. The SVB Warrants are not traded in an active market. A liquidity discount of 20% has been applied to the per warrant fair value to account for the lack of marketability of the instruments. As at March 31, 2018, the SVB Warrants derivative liability had a fair value of $4,581 (September 30, 2017 - $10,275). The Company has recorded the resulting change in fair value of $5,694 (2017 - $Nil) in the statement of loss and comprehensive loss.

 

Valuation

 

The Company uses the Black-Scholes option pricing model to estimate value. The following weighted average assumptions were used to estimate the fair value of the derivative warrant liabilities on initial recognition in the fiscal periods presented (November 18, 2016 with respect to the SVB Warrants), September 30, 2017 and March 31, 2018:

 

             
    March 31,
2018
  September 30,
2017
  November 18,
2016
             
Risk-free interest rate     2.70%     1.78%     1.32%
Expected life     3.25 years       3.67 years       7.00 years  
Expected annualized volatility     74.5%     74.2%     75.4%
Dividend     —         —            

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

8.       DERIVATIVE LIABILITIES (cont’d...)

 

Sensitivity

 

The derivative warrants are a recurring Level 3 fair value measurement. The key level 3 inputs used by management to determine the fair value are the market price and expected volatility. If the market price were to increase by a factor of 10% this would increase the obligation by approximately $15,047 as at March 31, 2018. If the market price were to decrease by a factor of 10% this would decrease the obligation by approximately $13,938 as at March 31, 2018. If the volatility were to increase by 10%, this would increase the obligation by approximately $36,042 as at March 31, 2018. If the volatility were to decrease by 10%, this would decrease the obligation by approximately $29,408 as at March 31, 2018.

 

The following table is a continuity schedule of changes to the Company’s derivative liabilities:

 

     
    Total
     
Balance, September 30, 2016   $ 7,309,467  
    Derivative liability on issuance of warrants     167,022  
    Change in fair value     (7,305,746 )
         
Balance, September 30, 2017   $ 170,743  
    Change in fair value     (97,813 )
         
Balance, March 31, 2018   $ 72,930  
         
Derivatives with expected life of less than one year   $ —    
Derivatives with expected life greater than one year   $ 72,930  

 

9.       SHAREHOLDERS’ EQUITY (DEFICIENCY)

 

Authorized

 

Unlimited common shares, without par value.

 

Unlimited preferred shares, without par value.

 

Effective April 25, 2018, the Company consolidated its issued and outstanding common shares on a basis of one post-consolidation share for 20 pre-consolidation shares. Unless otherwise stated, all share and per share amounts have been restated respectively to reflect this share consolidation.

 

Listing on the TSX-V and Nasdaq

 

The Company completed its listing on the Nasdaq on July 9, 2015 and began trading under the symbol “EPIX”.

 

On July 21, 2017, the Company received notifications from the Nasdaq that it was not in compliance with two requirements for continued listing, being the maintenance of a minimum bid price of US$1 and a minimum market value of US$35,000,000, noncompliance constituting continued deficiency for a period of 30 consecutive business days. The Company has been provided a grace period for 180 calendar days to regain compliance with these requirements.

 

On January 18, 2018, the Company received notification from the Nasdaq indicating that it had (i) demonstrated compliance with the minimum stockholders’ equity standard upon completion of the January 2018 Financing, and (ii) a further grace period of 180 calendar days, to July 16, 2018, had been granted to the Company in relation to regaining a minimum bid price of US$1.00.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

9.       SHAREHOLDERS’ EQUITY (DEFICIENCY) (cont’d...)

 

Listing on the TSX-V and Nasdaq (cont’d...)

 

On November 27, 2017, the Company voluntarily delisted from the TSX and began trading on the TSX-V under its existing symbol “EPI”.

 

Financings

 

On January 9, 2018, the Company closed the first tranche of a brokered equity offering (“ January 2018 Financing ”), issuing 3,427,250 common shares and 1,654,000 pre-funded warrants at a price of $4.00 each, for total gross proceeds of $20,325,000. Each warrant is exercisable, for a nominal exercise price, into one common share of the Company for a period of five years. In connection with the first tranche of the January 2018 Financing, the Company paid a cash commission of $1,204,000, incurred other financing costs of $2,020,209 including $420,917 of deferred financing costs as at September 30, 2017, and issued 175,937 broker warrants each exercisable into one common share of the Company at a price of $4.00 per share for a period of five years. The broker warrants were valued at $495,033 using the Black-Scholes model with a risk-free interest rate of 2.33%, term of 5 years, volatility of 82.00%, and dividend rate of 0%.

 

Concurrently, the Company completed a non-brokered private placement of 168,750 common shares at $4.00 per share as purchased by certain directors of the Company for total gross proceeds of $675,000.

 

On January 16, 2018, the Company closed the second tranche of the January 2018 Financing, issuing 465,000 common shares and 535,000 pre-funded warrants at a price of $4.00 each, for total gross proceeds of $4,000,000. Each warrant is exercisable, for a nominal exercise price, into one common share of the Company for a period of five years. In connection with the second tranche of the January 2018 Financing, the Company paid a cash commission of $352,800, incurred other financing costs of $370,999, and issued 63,000 broker warrants each exercisable into one common share of the Company at a price of $4.00 per share for a period of five years. The broker warrants were valued at $177,188 using the Black-Scholes model with a risk-free interest rate of 2.36%, term of 5 years, volatility of 81.90%, and dividend rate of 0%. Furthermore, on January 16, 2018, the Company’s agent partially exercised its over-allotment option for 260,000 additional common shares for additional proceeds to the Company of approximately $1,040,000.

 

In connection with the January 2018 Financing, Omega Fund IV, L.P. (“ Omega ”) acquired 465,000 common shares and 535,000 pre-funded warrants. Assuming the exercise in full of the 535,000 pre-funded warrants and certain warrants held by Omega prior to the January 2018 Financing, Omega would own approximately 17.6% of the issued and outstanding common shares as at January 16, 2018 on a partially-diluted basis. Pursuant to the terms of the a nomination rights agreement between the Company and Omega, Omega is entitled to nominate one director to the board of directors of the Company, one of which must be an independent director and preapproved by the Company. These nomination rights will continue for so long as Omega holds at least 9.99% of the issued and outstanding common shares.

 

The Company did not complete any financings during the year ended September 30, 2017.

 

10.       RESERVES

 

Equity incentive plans

 

Stock option plan

 

The Company has adopted a Stock Option Plan consistent with the policies and rules of the TSX-V and NASDAQ. Pursuant to the Stock Option Plan, options may be granted with expiry terms of up to 10 years, and vesting criteria and periods are approved by the Board of Directors at its discretion. The options issued under the Stock Option Plan are accounted for as equity-settled share-based payments.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

10.       RESERVES (cont’d...)

 

Equity incentive plans (cont’d...)

 

Restricted share units plan

 

The Company has adopted a Restricted Share Unit Plan (“RSU Plan”) consistent with the policies and rules of the TSX-V and NASDAQ. Pursuant to the RSU Plan, RSUs may be granted with vesting criteria and periods are approved by the Board of Directors at its discretion. The RSUs issued under the RSU Plan may be accounted for as either equity-settled or cash-settled share-based payments. At March 31, 2018, there are no RSUs outstanding.

 

The Stock Option Plan and RSU Plan have a combined maximum of 1,155,218 common shares which may be reserved for issuance.

 

Stock options

 

Stock option transactions are summarized as follows:

 

         
   

Number

of Options

 

Weighted

Average

Exercise Price*

         
Balance, September 30, 2016     203,126     $ 42.81  
     Options exercised     (250 )     (12.41 )
     Options expired/forfeited     (17,000 )     (39.71 )
                 
Balance, September 30, 2017     185,876     $ 43.12  
      Options granted     726,150       3.93  
      Options expired/forfeited     (53,565 )     (23.36 )
                 
Balance outstanding, March 31, 2018     858,461     $ 5.47  
Balance exercisable, March 31, 2018     65,613     $ 23.14  

 

Options exercisable in Canadian dollars as at March 31, 2018 are translated at current rates to reflect the current weighted average exercise price in US dollars for all outstanding options.

 

At March 31, 2018, options were outstanding enabling holders to acquire common shares as follows:

 

Exercise price Number of options Weighted average remaining contractual life (years)
         
  $       4.00     523,500     9.66  
  C$       4.90     286,000     9.57  
  C$       16.00     2,750     0.33  
  C$       40.00     45,961     1.38  
  C$       298.00     250     0.03*
                858,461     9.15  

 

* forfeited unexercised subsequent to March 31, 2018

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

10.       RESERVES (cont’d...)

 

Share-based compensation

 

During six months ended March 31, 2018, the Company granted 16,190,000 pre-consolidation (809,500 post-consolidation) (2017 - Nil) stock options with a weighted average fair value of $0.15 per pre-consolidation option (2017 - $Nil). The weighted average assumptions used for the Black-Scholes valuation of the options were annualized volatility of 82.47%, risk-free interest rate of 2.35%, expected life of 9.73 years and a dividend rate of Nil%.

 

During the six months ended March 31, 2018, the Company amended the exercise prices and expiry dates of 1,667,000 outstanding pre-consolidation (83,350 post-consolidation) stock options to pre-consolidation exercise prices of either C$0.245 or $0.20 (C$4.90 or $4.00 post-consolidation), and expiry dates ranging from October 1, 2023 to August 9, 2026. This resulted in additional share-based payments expense of $17,502 for the six months ended March 31, 2018. The weighted average assumptions used for the Black-Scholes valuation of the modified options were annualized volatility of 77.80%, risk-free interest rate of 2.66%, expected life of 7.28 years and a dividend rate of Nil%.

 

The Company recognized share-based payments expense for options granted and vesting, net of recoveries on cancellations of unvested options, during the period with allocations to its functional expense as follows:

 

         
    2018   2017
         
Research and development (Note 17)   $ 85,396     $ 84,303  
General and administrative (Note 17)     387,111       490,749  
    $ 472,507     $ 575,052  

 

Warrants

 

Warrant transactions are summarized as follows:

 

         
    Number
of Warrants
  Weighted
Average
Exercise Price
         
Balance, September 30, 2016     354,977     $ 65.60  
Warrants granted     7,477       42.80  
Warrants expired     (12,818 )     55.00  
                 
Balance, September 30, 2017     349,636     $ 65.38  
Warrants granted     2,427,938       0.40  
Warrants expired     (113,636 )     66.00  
                 
Balance outstanding and exercisable, March 31, 2018     2,663,938     $ 6.13  

 

Warrants exercisable in Canadian dollars as at March 31, 2018 are translated at current rates to reflect the current weighted average exercise price in US dollars for all outstanding warrants.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

10.       RESERVES (cont’d...)

 

Warrants (cont’d...)

 

At March 31, 2018, warrants were outstanding enabling holders to acquire common shares as follows:

 

 

Number

of Warrants

 

Exercise

Price

 

 

Expiry Date

           
  1,250   C$40.00   April 15, 2019
  227,273 (1) US$66.00   January 14, 2023
  7,477   US$42.80   November 18, 2023
  1,654,000 (2) US$0.002   January 9, 2023
  175,938   US$4.00   January 9, 2023
  535,000 (2) US$0.002   January 16, 2023
  63,000   US$4.00   January 16, 2023
  2,663,938        

 

(1) Detailed terms of the 2016 Warrants are included in Note 8.
(2) Pre-funded warrants are included in reserves at the price paid by holders of $4.00 per pre-funded warrant (Note 9).

 

11.       SUPPLEMENTAL DISCLOSURE WITH RESPECT TO CASH FLOWS

 

During the six months ended March 31, 2018, the Company issued broker warrants valued at $672,221 in connection with the January 2018 Financing (Note 9).

 

During the six months ended March 31, 2017, the Company issued warrants valued at $208,777 in connection with the SVB term loan (Note 7).

 

12.       RELATED PARTY TRANSACTIONS

 

Key management personnel of the Company include the President and Chief Executive Officer, Chief Financial Officer, Chief Technical Officer, Chief Scientific Officer, former Chief Medical Officer, Executive VP and Chief Operating Officer, former Executive VP of Research and Development, and Directors of the Company. Compensation paid to key management personnel is as follows:

 

         
         
    2018   2017
         
Salaries, consulting fees, and director fees   $ 1,662,586     $ 1,073,077  
Share-based payments, net of cancellations (a)     454,650       524,360  
Total compensation   $ 2,117,236     $ 1,597,437  

(a) Share-based payments to related parties represents the fair value of options granted and vested in the period to key management personnel net of expense reversed for options cancelled before vesting.

 

During the six months ended March 31, 2018, the Company modified 73,000 (2017 - Nil) options held by and granted 682,000 (2017 - Nil) options to key management personnel. The vesting of these options and options granted to key management personnel in prior periods were recorded as share-based payments expense in the statement of loss and comprehensive loss at a value of $454,650 (2017 - $524,360).

 

Included in accounts payable and accrued liabilities at March 31, 2018 is $387,997 (September 30, 2017 - $219,031) due to related parties with respect to key management personnel compensation and expense reimbursements. Amounts due to related parties are non-interest bearing, with no fixed terms of repayment.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

12.       RELATED PARTY TRANSACTIONS (cont’d...)

 

Commitments

 

The CEO is entitled to a payment of six months of base salary upon termination without cause, increasing to one year following one year of employment. Additionally, the CEO is entitled to 18 months of salary if termination without cause occurs after a change of control event or within 60 days prior to a change of control event where such event was under consideration at the time of termination.

 

The CFO is entitled to a payment of one year of base salary upon termination without cause, whether or not the termination was caused by a change of control event.

 

The COO is entitled to a payment of six months of base salary upon termination without cause, increasing to one year following one year of employment. Additionally, the COO is entitled to 18 months of salary if termination without cause occurs within 18 months after a change of control event.

 

Stock options held by the CEO, CFO, former Executive Vice-President of Research and Development, and COO vest immediately upon a change of control.

 

13.       SEGMENTED INFORMATION

 

The Company works in one industry being the development of small molecule drugs for prostate cancer. The Company’s equipment is located in the USA.

 

14.       CAPITAL MANAGEMENT

 

The Company considers its capital to include working capital, long-term debt and the components of shareholders’ equity. The Company monitors its capital structure and makes adjustments in light of changes in economic conditions and the risk characteristics of the underlying assets. To maintain or adjust the capital structure, the Company may issue new equity if available on favourable terms. Future financings are dependent on market conditions and the ability to identify sources of investment. There can be no assurance the Company will be able to raise funds in the future.

 

On November 18, 2016, the Company entered into the SVB Term Loan (Note 7), pursuant to which the Company has drawn down $8,000,000 as at March 31, 2018.

 

In January 2018, the Company completed financings totaling $26,040,000 in gross proceeds (Note 9).

 

There were no changes to the Company’s approach to capital management during the six months ended March 31, 2018. As at March 31, 2018, the Company is not subject to externally imposed capital requirements.

 

15.       FINANCIAL INSTRUMENTS AND RISK

 

The Company’s financial instruments consist of cash, receivables, accounts payable and accrued liabilities, long-term debt and derivative liabilities. Cash is measured based on level 1 inputs of the fair value hierarchy. The fair value of receivables and accounts payable and accrued liabilities approximates their carrying values due to their short term to maturity. The fair value of the SVB Term Loan is approximately $8,734,000 which includes the principal and financing costs assessed on settlement as at March 31, 2018. The derivative liabilities are measured using level 3 inputs (Note 8).

 

Fair value estimates of financial instruments are made at a specific point in time, based on relevant information about financial markets and specific financial instruments. As these estimates are subjective in nature, involving uncertainties and matters of judgement, they cannot be determined with precision. Changes in assumptions can significantly affect estimated fair values.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

15.       FINANCIAL INSTRUMENTS AND RISK (cont’d...)

 

Financial risk factors

 

The Company’s risk exposures and the impact on the Company’s financial instruments are summarized below:

 

Credit risk

 

Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash and receivables. The Company’s receivables are primarily due to refundable GST and investment tax credits. The Company limits its exposure to credit loss by placing its cash with major financial institutions. Credit risk with respect to investment tax credits and GST is minimal as the amounts are due from government agencies.

 

Liquidity risk

 

The Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities when due. As at March 31, 2018, the Company had a working capital of $17,854,975. The SVB Term Loan is repayable over a 33 month period ending September 1, 2020. The Company does not generate revenue and will be reliant on external financing to fund operations and repay the SVB Term Loan. Debt and equity financing is dependent on market conditions and may not be available on favorable terms. During the six months ended March 31, 2018, the Company completed a financing for total gross proceeds of $26,000,000 (Note 9).

 

Market risk

 

Market risk is the risk of loss that may arise from changes in market factors such as interest rates, and foreign exchange rates.

 

(a)       Interest rate risk

 

As at March 31, 2018, the Company has cash balances which are interest bearing. Interest income is not significant to the Company’s projected operational budget and related interest rate fluctuations are not significant to the Company’s risk assessment.

 

The Company’s SVB Term Loan is interest-bearing debt at a variable rate. A 10% change in the WSJ Prime Rate would result in an increase of $21,705 or decrease of $13,851 in the net loss realized for the period.

 

(b)       Foreign currency risk

 

Historically, the Company’s foreign currency risk exposure relates to net monetary assets denominated in Canadian dollars. A 10% change in the foreign exchange rate between the Canadian and U.S. dollar would result in a fluctuation of $51,718 in the net loss realized for the period. The Company does not currently engage in hedging activities.

 

(c)       Price risk

 

The Company is exposed to price risk with respect to equity prices. The Company closely monitors individual equity movements, and the stock market to determine the appropriate course of action to be taken by the Company.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

16.       COMMITMENTS

 

The Company has the following obligations over the next five years:

 

                     
                     
Contractual obligations   2018   2019   2020   2021   2022
                     

Minimum annual royalty per License

           Agreement (Note 6)

   

 

C$ -   

     

 

C$ 85,000

     

 

C$ 85,000

     

 

C$ 85,000

     

 

C$ 85,000

 

Collaborative Research Agreement

           with BC Cancer Agency

    51,838       —         —         —         —    
                                         
Total (in C$)     C$ 51,838       C$ 85,000       C$ 85,000       C$ 85,000       C$ 85,000  
                                         
SVB loan payments (Note 7)   $ 1,617,654     $ 3,240,219     $ 3,929,334     $ —       $ —    
Lease on US office spaces   $ 86,218     $ 175,166     $ 44,474     $ —       $ —    
                                         

 

Product Development and Relocation Grant

 

In February 2014 the Company received notice that it had been awarded a product development and relocation grant by the CPRIT whereby the Company is eligible to receive up to $12,000,000 on eligible expenditures over a three year period related to the development of the Company’s androgen receptor n-terminus blocker program for prostate cancer. The funding under CPRIT is subject to a number of conditions including negotiation and execution of an award contract which details the milestones that must be met to release the tranched CPRIT funding, proof the Company has raised the 50% matching funds to release CPRIT monies, and relocation of the project to the State of Texas such that the substantial functions of the Company related to the project grant are in Texas and the Company uses Texas-based subcontractor and collaborators wherever possible.

 

As at September 30, 2016, the Company had received the first two tranches of the CPRIT Grant, totalling $6,578,000, which have been recognized as research and development recoveries in the statements of loss and comprehensive loss over fiscal years 2014, 2015, and 2016. During the year ended September 30, 2017, the Company received $5,192,799, representing a partial payment of the third and final tranche of the grant of $5,422,000; the remaining balance of $229,201 is expected to be received on approval of final compliance reporting by CPRIT’s oversight body.

 

If the Company is found to have used any grant proceeds for purposes other than intended, is in violation of the terms of the grant, or relocates its operations outside of the State of Texas, then the Company is required to repay any grant proceeds received.

 

Under the terms of the grant, the Company is also required to pay a royalty to CPRIT, comprised of 4% of revenues until aggregate royalty payments equal $24,000,000, and 2% of revenues thereafter. The Company has the option to terminate the grant agreement by paying a one-time, non-refundable buyout fee, based on certain factors including the grant proceeds, and the number of months between the termination date and the buyout fee payment date.

 

Agency Engagements

 

In the year ended September 30, 2017, the Company executed Engagement Letters with Bloom Burton & Co. (“Bloom Burton”) and H.C. Wainwright & Co. (“HCW”), investment banks, to retain their services to act as its exclusive agents in Canada and the United States, respectively, in connection with a proposed financing. For a period of 12 months ending July 3, 2018, HCW will have a right of participation to act as a placement agent or underwriter on any equity financings for the Company, for which HCW shall receive a fee of no less than 25% of the fee on such financings.

 

 
 

 

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

17.       EXPENSES BY NATURE

 

Research and development expenses include the following major expenses by nature:

 

                 
    Three months ended
March 31, 2018
  Three months ended
March 31, 2017
  Six months ended
March 31, 2018
  Six months ended
March 31, 2017
                 
Clinical   $ 1,008,515     $ 991,740     $ 1,165,072     $ 1,827,661  
Consulting     123,951       227,710       433,188       466,914  
Legal patents and license fees     141,415       165,273       263,981       340,395  
Manufacturing     80,512       1,481,642       173,927       2,411,463  
Other     16,245       72,310       17,890       170,901  
Pharmacology     134,350       86,354       177,049       237,474  
Program administration     111,483       94,243       191,076       187,339  
Royalties     66,929       48,863       66,929       48,863  
Salaries and benefits     204,604       501,035       367,196       975,608  
Share-based payments (Note 10)     90,855       38,747       85,396       84,303  
Travel     10,248       40,844       17,000       82,146  

CPRIT grant claimed on eligible expenses

     (Note 16)

    —         (1,200,000 )     —         (5,192,799 )
                                 
Total   $ 1,989,107     $ 2,548,761     $ 2,958,704     $ 1,640,268  

 

General and administrative expenses include the following major expenses by nature:

 

                 
    Three months ended
March 31, 2018
  Three months ended
March 31, 2017
  Six months ended
March 31, 2018
  Six months ended
March 31, 2017
                 
Amortization   $ 9,971     $ 11,537     $ 19,943     $ 23,073  
Consulting and subcontractor fees     37,001       20,166       55,908       42,869  
Director fees     64,333       57,500       112,083       95,000  
Insurance     113,696       100,671       228,530       208,061  
Investor relations     98,428       72,136       143,282       119,466  
Office, IT and communications     40,544       50,909       66,168       121,355  
Professional fees     336,274       203,238       429,876       386,593  
Regulatory fees and transfer agent     120,508       24,131       140,746       45,895  
Rent     105,429       120,224       216,298       231,818  
Salaries and benefits     906,629       440,628       1,261,925       857,121  
Share-based payments (Note 10)     293,264       202,877       387,111       490,749  
Travel and entertainment     53,640       59,476       76,222       111,312  
                                 
Total   $ 2,179,717     $ 1,363,493     $ 3,138,092     $ 2,733,312  

 

18.       SUBSEQUENT EVENT

 

Subsequent to March 31, 2018, the Company issued a total of 64,750 stock options to employees, exercisable at $4.00 per share for a period of 10 years.

 

 

Exhibit 99.2

 

 

 

 

 

 

 

FORM 51-102F1

MANAGEMENT’S DISCUSSION AND ANALYSIS

FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ESSA Pharma Inc.

900 West Broadway - Suite 720

Vancouver, BC

V5Z 1K5

Canada

ESSA Pharmaceuticals Corp.

2130 West Holcombe Blvd - Suite 900

Houston, TX

77030

USA

 

 

1
 

 

Management’s Discussion and Analysis   March 31, 2018
 

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED MARCH 31, 2018 AND 2017

 

This management’s discussion and analysis (“ MD&A ”) of ESSA Pharma Inc. (the “ Company ” or “ ESSA ”) for the six months ended March 31, 2018 and 2017 is dated as of May 14, 2018.

 

This MD&A has been prepared with reference to National Instrument 51-102 - Continuous Disclosure Obligations of the Canadian Securities Administrators.  This MD&A should be read in conjunction with the unaudited condensed consolidated interim financial statements for the six months ended March 31, 2018 and 2017, the audited consolidated financial statements for the years ended September 30, 2017, 2016 and 2015, and the related notes thereto. The condensed consolidated interim financial statements are prepared in accordance with International Financial Reporting Standards (“ IFRS ”). Financial information presented in this MD&A is presented in United States dollars (“USD” or “$” or “US$”), unless otherwise indicated. Canadian dollars are presented as “C$” or “CAD”, where indicated.

 

This MD&A contains certain “forward-looking statements” and certain “forward-looking information” as defined under the United States Private Securities Litigation Reform Act and applicable Canadian securities laws. Please refer to the discussion of forward-looking statements set out under the heading “Cautionary Note Regarding Forward-Looking Statements”, located at the end of this document. As a result of many factors, the Company’s actual results may differ materially from those anticipated in these forward-looking statements.

 

As at March 31, 2018, the Company’s common shares traded on the TSX Venture Exchange (“ TSX-V ”) under the symbol “EPI” and the Nasdaq Capital Market (“ Nasdaq ”) under the symbol “EPIX”.

 

OVERVIEW OF THE COMPANY

 

ESSA is a preclinical stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of prostate cancer in patients whose disease is progressing despite treatment with current therapies, including abiraterone and enzalutamide. The Company believes its preclinical series of compounds can significantly expand the interval of time in which patients suffering from castration-resistant prostate cancer (“ CRPC ”) can benefit from hormone-based therapies. Specifically, the compounds act by disrupting the androgen receptor (“ AR ”) signaling pathway, the primary pathway that drives prostate cancer growth, by preventing AR activation through selective binding to the Tau-5 region of the N-terminal domain (“ NTD ”) of the AR. In this respect, ESSA’s compounds differ from classical anti-androgens, since they interfere either with androgen synthesis, or with the binding of androgens to the ligand-binding domain (“ LBD ”), which is located at the opposite end of the receptor. A functional NTD is essential for activation of the AR; blocking the NTD inhibits AR-driven transcription. We believe that the transcription inhibition mechanism of ESSA’s preclinical series of compounds is unique, and has the advantage of bypassing identified mechanisms of resistance to the anti-androgens currently used in the treatment of CRPC. The Company has been granted by the United States Adopted Names (" USAN ") Council a unique USAN stem "-- aniten" to recognize this new mechanistic class. The Company refers to this series of proprietary compounds, currently in development, as the “ Aniten ” series. In preclinical studies, blocking the NTD has demonstrated the capability to prevent AR-driven gene expression. In addition, in a recently completed Phase I clinical trial of ESSA’s first-generation agent EPI-506 (as defined herein), prostate-specific antigen (“ PSA ”) declines, a sign of inhibition of AR-driven biology, was observed at higher dose levels.

 

According to the American Cancer Society, in the United States, prostate cancer is the second most frequently diagnosed cancer among men, behind skin cancer. Approximately one-third of all prostate cancer patients who have been treated for local disease will subsequently have rising serum levels of PSA, which is an indication of recurrent or advanced disease. Patients with advanced disease often undergo androgen ablation therapy using analogues of luteinizing hormone releasing hormone (“ LHRH ”) or surgical castration; this approach is termed “androgen deprivation therapy”, or “ADT”. Most advanced prostate cancer patients initially respond to androgen ablation therapy; however, many experience a recurrence in tumor growth despite the reduction of testosterone to castrate levels, and at that point are considered to have CRPC. Following diagnosis of CRPC, patients have been generally treated with anti-androgens, which block the binding of androgens to the AR. More recently, greater results have been achieved by utilizing the latest generation of anti-androgens, such as abiraterone, in combination in newly diagnosed metastatic prostate cancer.

 

      2

 

Management’s Discussion and Analysis   March 31, 2018
 

  

The growth of prostate tumors is mediated by an activated AR. Generally, there are three means of activating the AR. First, androgens such as dihydrotestosterone can activate AR by binding to its LBD. Second, CRPC can be driven by constitutively-active variants of AR (“ vAR ”) that lack a LBD and do not require androgen for activation. The third mechanism involves certain signaling pathways that activate AR independent of androgen activity. Generally, current drugs for the treatment of prostate cancer work by focusing on the first mechanism in combination with either (i) interfering with the production of androgen, or (ii) preventing androgen from binding to the LBD. However, over time, these approaches eventually fail, due to mechanisms of resistance which all involve the LBD, whether at the DNA (AR amplification or LBD mutations) or RNA level (emergence of AR splice variants).

 

Through their potential to directly and selectively blocking all known means of activating the AR, the Company believes the Aniten series of compounds hold the potential to be effective in cases where current therapies have failed. Both preclinical and clinical studies support this belief. In preclinical studies, the Aniten series of compounds has been shown to shrink benign prostate tissue in mice as well as prostate cancer xenografts, including tumors both sensitive and resistant to the current generation anti-androgens such as enzalutamide. Recent studies have also suggested the potential for combinations of ESSA’s Aniten compounds with anti-androgens to potentially inhibit AR-driven biology in unique and complementary mechanisms by affecting opposite ends of the AR receptor.

 

The Phase I clinical trial of first-generation ralaniten acetate (“ EPI-506 ”), has confirmed the safety and tolerability for this mechanism of transcription inhibition of AR-driven biology aspatients tolerated doses of the drug at overall exposures consistent with those associated with efficacy in animal models. Possible proof of concept was shown with short duration PSA declines of up to 30% being observed in some patients. However, this first-generation drug was significantly metabolized in humans. High doses were required to achieve the desired overall exposures, with the relatively short half-life limiting the therapeutic level exposure of the drug within a 24 hour period. This limitation, together with unfavorable pharmaceutical properties, led to the Company’s decision to discontinue EPI-506 development in favor of focussing on the development of the next generation of Anitens. This next generation of Aniten agents include more potent drugs, with potentially increased resistance to metabolism as well as potentially superior pharmaceutical properties, including expected improvements to manufacturability, stability and likelihood for successful commercial formulation.

 

The NTD of AR is flexible with a high degree of intrinsic disorder making it difficult for use in crystal structure-based drug design. The Company is not currently aware of any success by other drug development companies in finding drugs that bind to this drug target. The nature of the highly specific binding of the Aniten compounds to the NTD, and the biological consequences of that binding, have been defined in recent scientific studies. The selectivity of the binding, based on in vivo imaging as well as in vitro studies, is consistent with the clean toxicological profile observed with the first-generation EPI-506.

 

According to the Decision Resources Group, in 2014 there were approximately 213,000 prevalent cases of CRPC, and such prevalence is expected to increase to approximately 235,000 cases in 2023. The Company expects that the Aniten series of compounds could be effective for many of those patients. In its early clinical development, the Company intends to initially focus on patients who have failed abiraterone or enzalutamide therapies for the following reasons:

CRPC treatment remains a prostate cancer market segment with an apparent and significant unmet therapeutic need and is therefore a potentially large market;
the Company believes that the unique mechanism of action of its Aniten compounds is well suited to treat those patients who have failed AR LBD focused therapies, and whose biological characterization reveals that their tumors are still largely driven by AR biology;
the Company expects that the large number of patients with an apparent unmet therapeutic need in this area will facilitate timely enrollment in its clinical trials; and
the Company believes that a successful Phase I clinical trial will facilitate the early study of the combination of ESSA’s Aniten compound with anti-androgens such as enzalutamide.

 

The British Columbia Cancer Agency (“ BCCA ”) and the University of British Columbia (“ UBC ”) are joint owners of the intellectual property that constitutes the Company’s primary asset. The Company licensed the EPI-family of drugs from UBC and the BCCA. The Company is party to a license agreement with the BCCA and UBC dated December 22, 2010, as amended (the “ License Agreement ”), which provides the Company with exclusive access to the issued patents and patent applications in respect of the EPI-series compounds, including the next generation Aniten compounds.

      3

 

Management’s Discussion and Analysis   March 31, 2018
 

 

The Company believes that it has developed a strong and defensive intellectual property position for multiple EPI structural classes, with 17 patent families filed covering different EPI structural motifs/analogues. Patents have been granted in 27 countries and are pending in 10 jurisdictions for the first generation NTD inhibitor EPI-002, with expiry in 2029.

Patent applications are pending in the United States and in contracting states to the Patent Cooperation Treaty (“ PCT ”) for the Aniten next-generation NTD inhibitors, with expiry in 2037.

 

Completed Phase I Clinical Study of EPI-506

 

The Company conducted an initial proof-of-concept Phase I clinical study utilizing the first-generation Aniten compound, EPI-506. The objective of the EPI-506 Phase I clinical trial was to explore the safety, tolerability, maximum tolerated dose and pharmacokinetics of EPI-506, in addition to tumor response rates in asymptomatic or minimally symptomatic patients with metastatic CRPC (“ mCPRC ”) who were no longer responding to either abiraterone or enzalutamide treatments, or both. Efficacy endpoints, such as PSA reduction, and other progression criteria were evaluated. Details relating to the design of the Phase I/II clinical trial of EPI-506 are available on the U.S. National Institutes of Health clinical trials website (see https://clinicaltrials.gov).

 

The Investigational New Drug (“ IND ”) application to the U.S. Food and Drug Administration (“ FDA ”) for EPI-506, to begin a Phase I clinical trial, was accepted in September 2015, with the first clinical patient enrolled in November 2015. The Company’s Canadian Clinical Trial Application (“ CTA ”) submission to Health Canada was subsequently also accepted. Based on allometric scaling, an initial dose level of EPI-506 of 80 mg was determined. However, following the enrollment of the initial cohorts, it became apparent that levels of EPI-506 were much lower in humans than the projections from the animal studies. Supported by the large therapeutic index from toxicology studies, to obtain exposures, as discussed further below, and successive cohorts received aggressive dose escalations. The highest dose patients ultimately received was 3600 mg of EPI-506, administered in a single dose or split into two doses daily. The initial data from the Phase I clinical trial was presented at the European Society of Medical Oncology (“ ESMO ”) meeting in September 2017.

 

Conducted at five sites in the United States and Canada, the open-label, single-arm, dose-escalation study evaluated the safety, pharmacokinetics, maximum-tolerated dose and anti-tumor activity of EPI-506 in men with end-stage mCRPC who had progressed after prior enzalutamide and/or abiraterone treatment and who may have received one prior line of chemotherapy. Twenty-eight patients were available for analysis, with each patient having received four or more prior therapies for prostate cancer at the time of study entry. Patients self-administered oral doses of EPI-506 ranging from 80 mg to 3600 mg, with a mean drug exposure of 85 days (range of eight to 535 days). Four patients underwent prolonged treatment (with a median of 318 days; and a range of 219 to 535 days at data cut-off), following intra-patient dose escalation. PSA declines, an indication of efficacy, ranging from 4% to 29% were observed in five patients, which occurred predominantly in the higher dose cohorts (≥1280 mg).

 

EPI-506 was generally well-tolerated with a favorable safety profile having been demonstrated across all doses up to 2400 mg. At a dose of 3600 mg, gastrointestinal adverse events (nausea, vomiting and abdominal pain) were observed in two patients: one patient in the once-daily (“ QD ”) dosing cohort and one patient in the 1800 mg twice-daily dosing cohort, leading to study discontinuation and a dose-limiting toxicity (“ DLT ”) due to more than 25% of doses being missed in the 28-day safety reporting period. A separate patient in the 3600 mg QD cohort experienced a transient Grade 3 increase in liver enzymes (AST/ALT), which also constituted a DLT, and enrollment was consequently concluded in this cohort.

 

Although the safety profile and possible signs of efficacy at higher-dose levels support the concept that inhibiting the AR NTD may provide a clinical benefit to mCRPC patients, the pharmacokinetic and metabolic studies revealed that the challenges encountered in achieving exposures similar to those associated with efficacy in the animal models were due to the greatly increased metabolism of EPI-506 in patients as compared to rodents. In light of these discoveries, ESSA concluded that prioritizing the development of one of its Aniten next-generation NTD inhibitors that, in the Company’s discovery program, had demonstrated greater potency, reduced metabolism and other enhanced pharmaceutical properties offered a more compelling regulatory and commercial pathway forward. As a result, the Company announced on September 11, 2017 its decision to discontinue the further clinical development of EPI-506 and to implement a corporate restructuring plan to focus research and development resources on its next-generation Anitens targeting the AR NTD. The restructuring included a decrease in headcount and a reduction of operational expenditures related to the clinical program.

 

      4

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

ESSA’s next-generation Aniten compounds are based on the binding scaffold in the first-generation drugs and appear to retain the specific binding and NTD inhibition of the AR. However, they have demonstrated an ability to improve upon a number of attributes of the first-generation compound, EPI-506. In several in vitro assay measuring inhibition of AR transcriptional activity, these drugs have demonstrated more potency than EPI-506 or its active metabolite, EPI-002. In addition, the compounds have been modified in an effort to reduce metabolic vulnerabilities. Lastly, the compounds are designed to improve upon the pharmaceutical properties of EPI-506, including in the areas of formulation, stability and ease of manufacture, to enable a more efficient and cost-effective formulation approach. The Aniten program is currently at the IND lead-selection stage with IND and CTA filings expected to occur in the first half of calendar 2019.

 

Strategy

 

The Company’s initial therapeutic goal is to develop a safe and effective therapy for prostate cancer patients whose tumors have progressed on current anti-androgen therapy. However, the action of the NTD-inhibiting Aniten compounds suggests that there may be additional therapeutic advantage to combining these agents with anti-androgens at an earlier stage of treatment. Therefore, while the first priority is to select and enter into Phase I development of an optional NTD inhibitor, the Company is also conducting preclinical studies of combination therapy with academic and industry collaborators.

 

Identifying an Aniten compound to take into clinical trials

 

The purpose of the next-generation program is to identify drug candidates with improved potency, reduced metabolic susceptibility and superior pharmaceutical properties compared to ESSA’s first-generation compounds. Structure-activity relation studies conducted on the chemical scaffold of ESSA’s first-generation compounds have resulted in generation of a new series of compounds that have demonstrated higher potency. Additional changes in the chemical scaffold have also been incorporated with the goal of improving ADME and pharmaceutical properties of the chemical class.

 

In preclinical models of AR inhibition, several candidate molecules have displayed 5 to 10 times higher potency than EPI-002. ESSA intends to conduct additional preclinical studies to identify a possible lead candidate for further IND-enabling studies. If these preclinical studies proceed as planned, the Company expects that the nomination of a next-generation drug candidate could occur in the second half of calendar 2018 with the filing of an IND with the FDA and CTA with Health Canada expected in the first half of calendar 2019.

 

Advancing a potential future product candidate through clinical development and regulatory approval in CRPC patients

 

Following successful identification, characterization and IND approval of a development candidate, the Company intends to conduct a Phase I clinical trial to determine the safety, tolerability, maximum tolerated dose, pharmacokinetics and potential therapeutic benefits of the drug in CRPC patients. Depending on the number of cohorts enrolled, the Phase I clinical trial is expected to take nine to twelve months. Once the Phase I clinical trial is complete, the Company plans to review the data, including the safety, tolerability, evidence of efficacy and pharmacological and biomarker data. This information will inform the final size, design and timing of a potential Phase II clinical trial.

 

Developing a potential future product candidate as an essential component of a new standard of care for the treatment of pre-CRPC and expanding usage earlier in the disease stage

 

An activated AR is required for the growth and survival of most prostate cancer, and NTD inhibition of AR-directed biology occurs both in full length “wild-type” AR and in the setting of the multiple resistance mechanisms affecting the anti-androgens which work through the opposite end of the AR. The Company, therefore, believes that the AR NTD is an ideal target for next-generation hormone therapy. If ESSA’s potential future product candidate is successful in treating CRPC patients, it is reasonable to expect that such clinical candidate may be effective in treating earlier stage patients. Therefore, the Company may conduct additional clinical studies potentially leading to the approval of a clinical candidate for use in prostate cancer patients at an earlier disease stage likely in combination with anti-androgens. The Company is currently generating in vitro and in vivo data in collaboration with academic and industry investigators in this regard. Preliminary data indicates that there may be potential benefits to combining an NTD inhibitor, such as an Aniten compound, with an anti-androgen that works through inhibition of the LBD of the AR. Other emerging potential clinical applications for NTD inhibitors are in combination with other agents, such as poly ADP ribose polymerase inhibitors, as well as in the subset of metastatic breast cancer patients whose tumors have been demonstrated to have activation of the AR pathway.

 

      5

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

Evaluating strategic collaborations to maximize value

 

The Company currently retains all commercial rights for its EPI and Aniten series drug portfolio. The Company continues to evaluate potential collaborations that could enhance the value of its prostate cancer program and allow it to leverage the expertise of such strategic collaborators.

 

CORPORATE UPDATE AND OVERALL PERFORMANCE

 

ESSA is a preclinical stage company and does not currently generate revenue. During the six months ended March 31, 2018, the Company recorded a comprehensive loss of $6,472,897 (2017 - $6,146,117). As of March 31, 2018, the Company had cash resources of $21,691,588 (September 30, 2017 - $3,957,185) and a working capital of $17,854,975 (September 30, 2017 - $1,281,551).

 

Effective April 25, 2018, the Company consolidated its issued and outstanding common shares on the basis of one (1) post-consolidation common share for every twenty (20) pre-consolidation common shares. As a result, the Company issued a press release on May 10, 2018 that stated the Company received written confirmation from the Listing Qualifications Department of the Nasdaq notifying the Company that it has regained compliance with Nasdaq Listing Rule 5550(a)(2) as a result of maintaining the $1.00 minimum closing bid price for at least ten consecutive trading days. Unless otherwise stated, all share and per share amounts have been restated retrospectively to reflect this share consolidation.

 

This corporate update highlights significant events and transactions for the six months ended March 31, 2018 and for the subsequent period to the date of this MD&A.

 

Corporate and Finance Highlights

 

TSX-V Listing

 

On November 27, 2017, the Company voluntarily delisted from the TSX and began trading its common shares on the TSX-V under the same symbol, “EPI”, to allow for improved operating efficiency, lower costs, and enhanced financing flexibility, while providing shareholders continued liquity on a recognized stock exchange.

 

Equity Financing

 

On January 9, 2018, the Company closed the first tranche of a brokered equity offering (the “ January 2018 Financing ”), issuing 3,427,250 common shares and 1,654,000 pre-funded warrants at a price of $4.00 each, for total gross proceeds of $20,325,000. Each warrant is exercisable, for a nominal exercise price, into one common share of the Company for a period of five years. In connection with the first tranche of the January 2018 Financing, the Company paid total cash commissions of $1,204,000, incurred other financing costs of $2,020,209 including $420,917 of deferred financing costs at September 30, 2017, and issued 175,937 broker warrants, each exercisable into one common share of the Company at a price of $4.00 per common share for a period of five years.

 

Concurrently, the Company completed a non-brokered private placement of 168,750 common shares at $4.00 per share to certain directors of the Company for total gross proceeds of $675,000.

 

      6

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

On January 16, 2018, the Company closed the second tranche of the January 2018 Financing, issuing 465,000 common shares and 535,000 pre-funded warrants at a price of $4.00 each, for total gross proceeds of $4,000,000. Each warrant is exercisable, for a nominal exercise price, into one common share of the Company for a period of 5 years. In connection with the second tranche of the January 2018 Financing, the Company paid total cash commissions of $352,800, incurred other financing costs of $370,999, and issued 63,000 broker warrants, each exercisable into one common share of the Company at a price of $4.00 per common share for a period of five years. Furthermore, on January 16, 2018, the Company’s agent partially exercised its over-allotment option for 260,000 additional common shares for additional proceeds to the Company of approximately $1,040,000.

 

In connection with the January 2018 Financing, Omega Fund IV, L.P. (“ Omega ”) acquired 465,000 common shares and 535,000 pre-funded warrants. Assuming the exercise in full of the 535,000 pre-funded warrants and certain warrants held by Omega prior to the January 2018 Financing, Omega would own approximately 17.6% of the issued and outstanding common shares as at January 16, 2018 on a partially-diluted basis. Pursuant to the terms of a nomination rights agreement between the Company and Omega, Omega is entitled to nominate one director to the board of directors of the Company, who must be an independent director and preapproved by the Company. These nomination rights will continue for so long as Omega holds at least 9.99% of the issued and outstanding common shares of the Company. On January 16, 2018, Mr. Hugo Beekman of Omega Fund Management, LLC, was appointed to the board of directors of the Company.

 

Nasdaq Deficiency

 

On July 20 and July 21, 2017, the Company received notifications from the Nasdaq indicating that it was not in compliance with two requirements for continued listing, being (i) the maintenance of a minimum bid price of $1.00 and (ii) either a minimum stockholder’s equity of $2,500,000, a minimum market value of $35,000,000 or a minimum $500,000 of net income from continuing operations, noncompliance constituting continued deficiency in respect of these requirements for a period of 30 consecutive business days.

 

The Nasdaq granted grace periods to the Company for 180 calendar days, to January 15 and January 16, 2018, respectively, to regain compliance with the above-mentioned requirements. During this time, the Company’s common shares continued to be listed and traded on the Nasdaq.

 

On January 18, 2018, the Company received notification from the Nasdaq indicating that it had (i) demonstrated compliance with the minimum stockholders’ equity standard upon completion of the January 2018 Financing, and (ii) a further grace period of 180 calendar days, to July 16, 2018, had been granted to the Company in relation to regaining a minimum bid price of US$1.00. Effective April 25, 2018, the Company completed a share consolidation on a basis of one (1) post-consolidation common share for every twenty (20) pre-consolidation common shares. As a result, the Company issued a press release on May 10, 2018 that stated the Company received written confirmation from the Listing Qualifications Department of the Nasdaq notifying the Company that it has regained compliance with Nasdaq Listing Rule 5550(a)(2) as a result of maintaining the $1.00 minimum closing bid price for at least ten consecutive trading days. Nasdaq has informed the Company that this matter is now closed.

 

Change to the Company’s Board of Directors

 

On January 16, 2018, Mr. Hugo Beekman of Omega Fund Management, LLC, was appointed to the board of directors of the Company in connection with the participation of Omega in the January 2018 Financing.

 

Change in Senior Management

 

On January 26, 2018, the Company announced that Frank Perabo, the Company’s Chief Medical Officer (“ CMO ”) had resigned from the Company, effective January 31, 2018. Dr. Perabo will continue to serve the Company in an advisory capacity.

 

Voting Agreement

 

On January 30, 2018, the voting agreement among certain of the Company’s shareholders, dated January 14, 2016, as further described in the Company’s management information circular dated January 27, 2017, was terminated.

 

      7

 

Management’s Discussion and Analysis   March 31, 2018

 

 

 

Research and Development Milestones

 

Progress in the selection of a potential future product candidate and filing an IND

 

During the period from the fourth calendar quarter of 2017 to the first calendar half of 2019, the Company has and will continue preclinical studies on the next-generation Aniten compounds. During such period, there are two key research and development milestones that the Company aims to achieve. The first milestone is the selection of a most promising candidate from the Aniten compounds, which will need to meet specific criteria, for the Company to take into the clinical trial stage. Following selection of this clinical candidate, the second milestone is the filing and approval of an IND with the FDA and a CTA with Health Canada.

 

DISCUSSION OF OPERATIONS

 

Preclinical Studies

 

The Company is focused on the advancement of next-generation Aniten NTD inhibitors designed to improve upon the properties of the first-generation compound, EPI-002, and its prodrug EPI-506. A series of oral small molecule compounds have been identified which, while retaining the common mechanism of action to interfere with AR-mediated signaling, hold the promise of improved properties such as enhanced potency, reduced susceptibility to metabolism and improved drug-like properties. Several of these compounds are currently being characterized in more detail with the goal of selecting a next-generation development compound based on certain established criteria. The Company also continues to conduct preclinical combination studies.

 

These next-generation compounds were discovered through chemical modification of the first-generation drug, EPI-002. Specific chemical changes to the structure of EPI-002 resulted in increased potency in an in vitro AR-based gene transcription assay, exhibiting 5 to 10 times higher potency than EPI-002. The ability of the first in the series of these next-generation molecules to reduce tumor growth was confirmed in a human prostate cancer xenograft model. In this preclinical study, the next-generation compound reduced tumor growth compared to the control using low daily doses of the drug.

 

In addition to higher potency, the next-generation compounds are designed to reduce the metabolism of these agents following oral dosing compared to EPI-002. Excessive metabolism of a drug candidate may reduce the effective exposure levels of a drug and necessitate frequent and excessive dosing requirements. Specific modifications in the chemical structure of these molecules were made in an attempt to block known sites of metabolism of EPI-002. A series of in vitro studies examining drug metabolism were conducted with the next-generation compounds. Results indicated that several of these compounds, with the additional chemical modifications, may be metabolized more slowly than EPI-002 in humans. Currently, the Company is conducting animal pharmacokinetic studies to verify the initial in vitro metabolism results. If this in vitro and in vivo data is replicated in patients, the reduced metabolism of the next-generation compounds may be expected to improve their pharmacokinetic profile and daily dose requirements following oral dosing compared to EPI-002.

 

Importantly, the next-generation compounds exhibiting less in vitro metabolism were tested against off-target screening. Significant off-target binding of drug candidates may lead to unanticipated toxicity. Several of these compounds showed minimal non-specific binding properties in this screening, indicating a favorable profile for further development. The most promising of these next-generation compounds were selected for further preclinical characterization.

 

Future Clinical Development Program

Phase I/II Clinical Trial Design for treating CRPC patients

 

If the Company successfully identifies a clinical candidate following preclinical studies of Aniten compounds, and approval of the IND and CTA are obtained, the Company will conduct a Phase I/II clinical trial to determine the safety, tolerability, maximum tolerated dose, pharmacokinetics, and efficacy of the compound in CRPC patients. In a Phase I study, it is expected the clinical trial will evaluate the safety, tolerability, pharmacokinetics, and maximum-tolerated dose of the compound, in multiple-dose escalations. Learnings from the Phase I clinical trial of EPI-506 will be incorporated into the design and conduct of potential future trials. The Company plans to include, for example, extensive biological characterization of the patients entered into the trial. If the Phase I portion of the clinical trial is successful, the Phase II portion (dose expansion) of the clinical trial will evaluate activity in a target group of biologically-characterized mCRPC patients.

 

      8

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

Early Conduct of a Combination Phase I/II Clinical Trial

 

Given the evolution of prostate cancer therapeutics towards combination therapy strategies, the biological rationale for combining NTD and LBD inhibitors, and compelling early in vitro and preclinical animal model results, the Company may perform combination studies of the next-generation Aniten compound with current generation anti-androgens.

 

Phase III Clinical Trial

 

In order to obtain full regulatory approval, the Company expects that it will be required to carry out at least one Phase III clinical trial, most likely in patients similar to the population of CRPC patients that will have been enrolled in the planned Phase I/II clinical trial. However, the results of the Phase I/II clinical trial may also suggest modification of the initial patient population based on response and biomarker assessment. In a Phase III clinical trial, the key end-point is expected to be progression-free survival or overall survival relative to patients receiving the standard-of-care. It is expected that such a Phase III clinical trial would be conducted at numerous sites around the world.

 

SELECTED QUARTERLY FINANCIAL INFORMATION

The following table summarizes selected unaudited consolidated financial data for each of the last eight quarters, prepared in accordance with IFRS. The Company has not earned any revenues or declared dividends as of March 31, 2018.

 

For the Quarters Ended

                 
   

March 31,

2018

 

December 31,

2017

 

September 30,

2017

 

June 30,

2017

                 
Total assets   $ 22,334,083     $ 3,433,234     $ 5,607,044     $ 8,405,965  
Long-term liabilities     4,797,841       5,421,942       6,103,835       7,105,830  
Research and development expense     1,989,107       969,597       1,165,917       2,920,181  
General and administration     2,179,717       958,375       1,105,295       1,302,314  
Comprehensive income (loss)   $ (4,382,956 )   $ (2,089,941 )   $ (1,945,299 )   $ 3,592,404  
Basic income (loss) per share     (0.83 )     (1.44 )     (1.34 )     2.47  
Diluted income (loss) per share     (0.83 )     (1.44 )     (1.34 )     2.47  

 

For the Quarters Ended

                 
   

March 31,

2017

 

December 31,

2016

 

September 30,

2016

 

June 30,

2016

                 
Total assets   $ 13,738,990     $ 15,980,790     $ 10,402,562     $ 13,666,625  
Long-term liabilities     15,931,442       13,029,510       7,309,467       8,350,043  
Research and development expense     2,548,761       (908,493 )     3,951,799       3,362,948  
General and administration     1,363,493       1,369,819       1,236,873       1,305,780  
Comprehensive income (loss)   $ (7,610,579 )   $ 1,464,462     $ (4,236,768 )   $ (3,865,757 )
Basic income (loss) per share     (5.23 )     1.01       (2.91 )     (2.66 )
Diluted income (loss) per share     (5.23 )     1.01       (2.91 )     (2.66 )

 

      9

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

The Company’s quarterly results have varied and may, in the future, vary depending on numerous factors, including the timing of CPRIT Grant funding, fluctuations in the Company’s derivative liabilities, and whether the Company has granted any stock options. Certain of these factors may not be predictable to the Company. CPRIT Grant funding is taken proportionately into income against research and development (“ R&D ”) expenses incurred to date, which in some cases may have been incurred in previous quarters. Fluctuations on derivative liabilities are discussed below under the subheading “ Derivative liabilities ” section below. The granting of stock options results in share-based payment charges, reflecting the vesting of such stock options.

 

In the quarters ended December 31, 2016 and March 31, 2017, the Company recorded the partial receipts of the third tranche of the CPRIT Grant of $3,992,799 and $1,200,000, respectively, which were recognized as recoveries of R&D expenditures. The CPRIT Grant is detailed in the accompanying condensed consolidated interim financial statements. The agreement providing for the CPRIT Grant was executed by the Chief Executive Officer of CPRIT on July 9, 2014 (the “ CPRIT Agreement ”) and the grant term ended on March 31, 2018, with final compliance reporting and approval for release of the remaining grant funds expected in the first half of calendar 2018.

 

In the quarter ended March 31, 2018, the Company completed the January 2018 Financing for gross proceeds of approximately $26,040,000.

 

Six months ended March 31, 2018 and 2017

 

The Company incurred a comprehensive loss of $6,472,897 for the six months ended March 31, 2018 compared to a comprehensive loss of $6,146,117 for the six months ended March 31, 2017. Significant differences between the periods include CPRIT Grant recoveries of $nil (2017 - $5,192,799) recognized against gross R&D expenditures of $2,958,704 (2017 $6,833,067), and a gain in derivative liability of $97,813 (2017 - $1,486,142 loss).

 

During the six months ended March 31, 2018, the Company concluded its clinical development of EPI-506 and implemented a corporate restructuring plan, previously announced on September 11, 2017, to focus its research and development resources on its next-generation Aniten compounds. In the prior period, the Company was continuing its clinical studies of EPI-506, resulting in higher clinical and manufacturing costs. This is reflected in total gross R&D expenditures of $2,958,704 (2017 - $6,833,067). Significant components of R&D expense in the current period include:

 

Clinical costs of $1,165,072 (2017 - $1,827,661) have decreased as a result of the Company’s completion of the EPI-506 Phase I/II clinical trial, which was terminated in September 2017.

 

Pharmacology costs of $177,049 (2017 - $234,474) have decreased compared to the comparative period in 2017 due to the completion of testing and experimentation on the Company’s EPI-series drugs.

 

Manufacturing costs of $173,927 (2017 - $2,411,463) have decreased compared to the comparative period in 2017 as the Company concluded of the EPI-506 Phase I/II clinical trial in September 2017.

 

Consulting fees were $433,188 (2017 - $466,914) including milestone bonuses payable to the Chief Scientific Officer and Chief Technical Officer on various publications and patent filings.

 

Legal patents and license fees have decreased to $263,981 (2017 - $340,395) as the Company previously submitted a number of patent applications. The Company has adopted a tiered patent strategy to protect its intellectual property as the pharmaceutical industry places significant importance on patents for the protection of new technologies, products and processes. The Company anticipates that there will be ongoing investment into patent applications.

 

Other R&D costs were $17,890 (2017 - $170,901) and relate to costs for medical affairs and regulatory matters, which were decreased as the Company reduced its expenditures in this area to focus on development of the next-generation Aniten program.

 

      10

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

Program administration fees were $191,076 (2017 - $187,339) and relate to fees payable pursuant to collaborative research agreements with the BCCA and UBC.
Salaries and benefits, related to preclinical and clinical staff in Texas and the Company’s former Chief Medical Officer, have decreased to $367,196 (2017 - $975,608) primarily as a result of the corporate structuring in September 2017 that led to reduced preclinical and clinical staff in Texas.

R&D expenses include the following major expenses by nature for the three and six months ended March 31, 2018 and 2017:

                 
    Three months ended
March 31, 2018
  Three months ended
March 31, 2017
  Six months ended
March 31, 2018
  Six months ended
March 31, 2017
                 
Clinical   $ 1,008,515     $ 991,740     $ 1,165,072     $ 1,827,661  
Consulting     123,951       227,710       433,188       466,914  
Legal patents and license fees     141,415       165,273       263,981       340,395  
Manufacturing     80,512       1,481,642       173,927       2,411,463  
Other     16,245       72,310       17,890       170,901  
Pharmacology     134,350       86,354       177,049       237,474  
Program administration     111,483       94,243       191,076       187,339  
Royalties     66,929       48,863       66,929       48,863  
Salaries and benefits     204,604       501,035       367,196       975,608  
Share-based payments (Note 10*)     90,855       38,747       85,396       84,303  
Travel     10,248       40,844       17,000       82,146  
CPRIT grant claimed on eligible expenses (Note 16*)     —         (1,200,000 )     —         (5,192,799 )
                                 
Total   $ 1,989,107     $ 2,548,761     $ 2,958,704     $ 1,640,268  

* See the Notes set out in the accompanying condensed consolidated interim financial statements for the six months ended March 31, 2018 and 2017.

 

General and administrative (“ G&A ”) expenses have increased from the prior period due to significant corporate and financing activity in the current period. Significant components of general and administrative expenses in the current six-month period include:

 

Professional fees for legal and accounting services of $429,876 (2017 - $386,593) and regulatory fees and transfer agent of $140,746 (2017 - $45,895) were incurred in conjunction with the corporate activities in the six month period ended March 31, 2018, including the January 2018 financing, the annual general meeting held in March 2018, and the recently effected 1:20 share consolidation.

 

Salaries and benefits expense has increased to $1,261,925 (2017 - $857,121) in comparison with the prior period in 2017 due to corporate staffing such as the Chief Executive Officer, Chief Financial Officer, and Chief Operating Officer, as disclosed in “ Related Party Transactions ”, and related bonuses paid in the current period.

 

      11

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

General and administrative expenses include the following major expenses by nature for the three and six months ended March 31, 2018 and 2017:

                 
    Three months ended
March 31, 2018
  Three months ended
March 31, 2017
  Six months ended
March 31, 2018
  Six months ended
March 31, 2017
                 
Amortization   $ 9,971     $ 11,537     $ 19,943     $ 23,073  
Consulting and subcontractor fees     37,001       20,166       55,908       42,869  
Director fees     64,333       57,500       112,083       95,000  
Insurance     113,696       100,671       228,530       208,061  
Investor relations     98,428       72,136       143,282       119,466  
Office, IT and communications     40,544       50,909       66,168       121,355  
Professional fees     336,274       203,238       429,876       386,593  
Regulatory fees and transfer agent     120,508       24,131       140,746       45,895  
Rent     105,429       120,224       216,298       231,818  
Salaries and benefits     906,629       440,628       1,261,925       857,121  
Share-based payments (Note 10*)     293,264       202,877       387,111       490,749  
Travel and entertainment     53,640       59,476       76,222       111,312  
                                 
Total   $ 2,179,717     $ 1,363,493     $ 3,138,092     $ 2,733,312  

* See the Notes set out in the accompanying condensed consolidated interim financial statements for the six months ended March 31, 2018 and 2017.

 

Derivative liabilities

 

The 2016 Warrants (as defined below) and the SVB Warrants (as defined below) have increased the Company’s exposure to fluctuations in the market price of the Company’s common stock. Under a cashless exercise, the 2016 Warrants and the SVB Warrants are exercisable for a variable number of common shares of the Company, resulting in embedded derivatives for which the Company has recognized derivative liabilities. These warrants are measured at fair value, with changes recognized in the statement of loss and comprehensive loss at each reporting date. During the six months ended March 31, 2018, the Company recorded the resulting change in fair value, largely resulting from the decrease in stock price during the period, of $91,934 (2017 - $1,482,572) for the 2016 Warrants and $5,694 (2017 - $Nil) for the SVB Warrants in the statement of loss and comprehensive loss.

 

Derivative warrant liabilities are discussed under the heading “ Critical Accounting Estimates ” and Note 8 of the accompanying condensed consolidated interim financial statements for the six months ended March 31, 2018 and 2017.

 

Three months ended March 31, 2018 and 2017

 

The Company incurred a comprehensive loss of $4,382,956 for the three months ended March 31, 2018 compared to a comprehensive loss of $7,610,579 for the three months ended March 31, 2017.

 

The detailed changes for the research and development and general and administrative expenses for the three months ended March 31, 2018 and 2017 are included in the tables above. In the current period, the Company has incurred costs in relation to the termination of its clinical studies of EPI-506, as well as continued its development of the next-generation Aniten compound, whereas in the comparative period in 2017 the Company was continuing its clinical studies of EPI-506; this is reflected in increased clinical costs of $1,008,515 (2017 - $991,740) and decreased manufacturing costs of $80,512 (2017 - $1,481,642) in relation to the clinical studies of EPI-506, offset by increased pharmacology costs of $134,350 (2017 - $86,354) in relation to the Aniten compound development.

 

General and administrative expenses of $2,179,717 (2017 - $1,363,493) have increased over the prior period, in particular for professional fees of $336,274 (2017 - $203,238) and regulatory fees and transfer agent of $120,508 (2017 - $24,131) in relation to the January 2018 financing, the annual general meeting held in March 2018, and the recently effected 1:20 share consolidation. Also, salaries and benefits of $906,629 (2017 - $440,628) reflect bonuses paid to senior management during the period.

 

      12

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

The January 2016 Financing gave issue to 227,273 warrants exercisable at $66.00 for 7 years and 113,636 warrants exercisable at $66.00 for 2 years (collectively, the “ 2016 Warrants ”), which were recorded as derivative liabilities carried at fair value under the Black Scholes valuation methodology. Consequently, the major disparity in comprehensive loss between fiscal 2018 and 2017 is largely driven by a gain of $9,250 (2017 - loss of $3,480,517) with respect to the fair value of the Company’s derivative liabilities.

 

USE OF PROCEEDS

 

During the six months ended March 31, 2018, the Company received total net proceeds of $23,648,792 from the January 2018 Financing.

 

During the year ended September 30, 2017, the Company received total net proceeds of $7,779,063 from a capital term loan with Silicon Valley Bank (the “ SVB Term Loan ”), pursuant to which the Company has currently drawn down $8,000,000. In connection with the SVB Term Loan, the Company also issued 7,477 warrants (the “ SVB Warrants ”), exercisable at a price of $42.80 per share.

 

The following table sets out a comparison of how the Company intended to use the proceeds from the above financings, based on its disclosure, against how the Company actually used the proceeds following the respective closing dates, an explanation of the variances and the impact of the variance on the ability of the Company to achieve its business objectives and milestones.

 

Intended Use of Proceeds Actual Use of Proceeds
The development of EPI-506 Phase I/II clinical program through Phase I / Preclinical development of next-generation Aniten compounds

The proceeds were initially used as intended to further the development of the EPI-506 Phase I/II clinical trial program while meeting administrative requirements, up until the fourth quarter of the fiscal year ended September 30, 2017, during which time the EPI-506 Phase I/II clinical trial program was terminated.

 

During the six months ended March 31, 2018, the Company incurred $2,958,704 in R&D costs, net of recoveries, in relation to the preclinical costs of the Aniten next generation compound, as well as close-out costs related to the termination of the EPI-506 Phase I/II clinical trial program. An additional $3,138,092 has been incurred for general and administrative costs in support of the Company’s research and development activities. The Company also completed $657,340 and $291,959 in principal and interest payments, respectively, on the SVB Term Loan.

 

During the year ended September 30, 2017, the Company incurred $5,726,366 in R&D costs, net of recoveries, in relation to the development of the EPI-506 Phase I/II clinical trial program. An additional $5,140,921 has been incurred for general and administrative costs in support of the Company’s research and development activities.

 

As at March 31, 2018, the Company has not yet fully expended the funds raised in its prior financings towards the completion of the EPI-506 Phase I/II clinical trial program, which concluded during the year. The Company intends to use remaining funds towards the preclinical development of its next-generation Aniten compounds.

 

      13

 

Management’s Discussion and Analysis   March 31, 2018

 

 

 

LIQUIDITY AND CAPITAL RESOURCES

 

As at March 31, 2018, the Company has working capital of $17,854,975 (September 30, 2017 - $1,281,551). Operational activities during the six months ended March 31, 2018 were financed mainly by proceeds from equity financings completed in January 2018, the SVB Term Loan, and the CPRIT Grant. At March 31, 2018, the Company had available cash reserves of $21,691,588 (September 30, 2017 - $3,957,185) and $58,527 (September 30, 2017 - $29,475) in accounts receivable related primarily to GST input tax credits, to settle current liabilities of $4,161,843 (September 30, 2017 - $3,777,212). The Company believes that it has sufficient capital to satisfy its obligations as they become due and execute its planned expenditures through the fiscal 2018 year.

 

Cash used in operating activities for the six months ended March 31, 2018 was $5,178,018 (2017 - $9,260,923). Working capital items generated cash of $415,242 (2017 - $313,022 cash used).

 

There were no cash flows from investing activities for the six months ended March 31, 2018 and 2017.

 

Cash generated by financing activities for the six months ended March 31, 2018 was $22,910,566 (2017 - $12,888,682), including $26,040,000 in gross proceeds received from the January 2018 financing, offset by $2,180,135 in share issuance costs and $657,340 and $291,959 in principal and interest paid in relation to the SVB Term Loan. In the six months ended March 31, 2017, the Company generated cash of $12,888,682 from financing activities including $5,192,799 as a partial receipt of the third and final tranche of the CPRIT Grant, $8,000,000 in gross proceeds received from the SVB Term Loan, offset by $156,895 in cash transaction costs and $147,222 in interest paid in relation to the SVB Term Loan.

 

The Company does not currently generate revenue. Future cash requirements may vary materially from those expected due to a number of factors, including the costs associated with preclinical activities as well as possible unanticipated costs resulting from strategic opportunities that may arise in the future. As a result, it will be necessary for the Company to raise additional funds in the future. These funds may come from sources such as entering into strategic collaboration arrangements, the issuance of shares from treasury, or alternative sources of financing; however, there can be no assurance that the Company will successfully raise the funds necessary to continue the preclinical development of its next-generation Anitens targeting the AR NTD and for its other operational activities (see “ Risk Factors ”).

 

CONTRACTUAL OBLIGATIONS

 

As of March 31, 2018, and in the normal course of business, the Company has the following obligations to make future payments, representing contracts and other commitments that are known and committed.

 

                         
Contractual obligations   2018   2019   2020   2021   2022   After 5 years
                         
Minimum annual royalty per License Agreement (CAD) (1)    

 

C$ -

     

 

C$ 85,000

     

 

C$ 85,000

     

 

C$ 85,000

     

 

C$ 85,000

     

 

C$ 765,000

 
Collaborative Research Agreement with BCCA (CAD)     51,838       —         —         —         —         —    
                                                 
Total (in CAD)     C$ 51,838       C$ 85,000       C$ 85,000       C$ 85,000       C$ 85,000       C$ 765,000  
Total (in USD) (2)   $ 40,203     $ 65,922     $ 65,922     $ 65,922     $ 65,922     $ 593,299  
                                                 
SVB loan payments (USD)   $ 1,617,654     $ 3,240,219     $ 3,929,334     $ —       $ —       $ —    
Lease on U.S. office spaces (USD)   $ 86,218     $ 175,166     $ 44,474     $ —       $ —       $ —    
                                                 
Total (USD)   $ 1,744,075     $ 3,481,307     $ 4,039,730     $ 65,922     $ 65,922     $ 593,299  
                                                 

 

      14

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

Notes:

(1) ESSA has the worldwide, exclusive right to develop products based on “Licensed IP”, as defined in, and pursuant to, the License Agreement. A copy of the License Agreement is available as Exhibit 4.2 to Amendment No. 1 to the Company’s Form 20-F registration statement filed on June 11, 2015 (File No. 001-37410) on the SEC’s Electronic Data Gathering and Retrieval System, or “ EDGAR ”, at www.sec.gov. Pursuant to the License Agreement, the Company was required to pay a minimum annual royalty of C$85,000 for the 2017 calendar year and for each year thereafter. Additional milestone payments of C$50,000 and C$900,000, which have been excluded from the above table, would have been due upon the enrolment of the first patient in Phase II and Phase III of the EPI-506 clinical trial, respectively, which had been expected to occur in 2017 and 2018.
(2) Converted based on the indicative exchange rate of the Bank of Canada of C$1.00 = $0.7756 as at March 31, 2018.

 

OFF-BALANCE SHEET ARRANGEMENTS & PROPOSED TRANSACTIONS

 

The Company has no material off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material effect on its results of operations, financial condition, revenues or expenses, liquidity, capital expenditures or capital resources.

 

The Company has no material proposed business acqusitions or dispositions that have, or are reasonably likely to have, a current or future material effect on its results of operations, financial condition, revenues or expenses, liquidity, capital expenditures or capital resources.

 

RELATED PARTY TRANSACTIONS

 

Compensation accrued and paid to key management personnel for the six months ended March 31, 2018 was as follows:

 

Name and Relationship Nature of compensation Amount (USD)
     
Richard Glickman, Director and Chairman of the Board Director fees (1) $ 33,500  
Gary Sollis, Director Director fees (1)   26,000  
Franklin Berger, Director Director fees (1)   24,000  
Scott Requadt, Director Director fees (1)   24,000  
Hugo Beekman, Director Director fees (1)   4,583  
 Dr. Marianne Sadar, Director and Chief Scientific Officer Consulting fees and bonus (2)   201,163  
 Dr. Raymond Andersen, Director and Chief Technical Officer Consulting fees and bonus (3)   121,607  
Dr. David R. Parkinson, Chief Executive Officer Salary and bonus (4)   439,697  
David Wood, Chief Financial Officer Salary and bonus (5)   227,696  
Peter Virsik, Executive Vice-President and Chief Operating Officer Salary and bonus (6)   329,412  
Dr. Frank Perabo, former Chief Medical Officer Salary and bonus (7)   230,928  
N/A Share-based payments (8)   454,650  
Total compensation   $ 2,117,236  

 

Note:

(1) The Company compensates its independent directors as follows: annual retainer of $25,000, additional annual retainer of $25,000 for the Chairman of the Board, additional annual retainer of $10,000 for committee chairs, $1,500 per board meeting attended in person, and $1,000 for all other board and subcommittee meetings.
(2) On December 22, 2010, the Company and Dr. Marianne Sadar entered into a consulting agreement, subsequently amended February 1, 2013 and February 1, 2015, whereby Dr. Sadar received a monthly consulting fee of C$15,000 and various bonuses payable on the achievement of milestones such as IND filings, contracted research objectives, publications and the filing of patents. The consulting agreement expired on January 31, 2018. Under a new consulting agreement,effective February 1, 2018, Dr. Sadar will receive an annual consulting fee of C$180,000 (C$15,000 monthly) and is eligible for a bonus of up to 25% of the annual consulting fee upon accomplishment of certain objectives as agreed upon by all parties.

 

      15

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

(3) On December 22, 2010, the Company and Dr. Raymond Andersen entered into a consulting agreement, subsequently amended February 1, 2013 and February 1, 2015, whereby Dr. Andersen received a monthly consulting fee of C$10,000 and various bonuses payable on achievement of milestones such as IND filings, contracted research objectives, publications and the filing of patents. The consulting agreement expired on January 31, 2018. Under a new consulting agreement,effective February 1, 2018, Dr. Andersen will receive an annual consulting fee of C$180,000 (C$15,000 monthly) and is eligible for a bonus of up to 25% of the annual consulting fee upon accomplishment of certain objectives as agreed upon by all parties.
(4) Dr. David R. Parkinson receives a base salary of $451,758 per annum and a performance-based bonus per annum of up to 50% of his base salary.
(5) David Wood receives a base salary of $236,900 per annum and a performance-based bonus per annum of up to 30% of his base salary.
(6) Peter Virsik receives a base salary of $375,950 per annum and a performance-based bonus per annum of up to 40% of his base salary.
(7) Dr. Frank Perabo received a base salary of $447,372 per annum. Dr. Perabo resigned as the CMO of the Company effective January 31, 2018 and will continue to serve the Company in an advisory capacity.
(8) Share-based payments to related parties represents the fair value of options granted and vested in the period to key management personnel.

 

Key management personnel include: Dr. David R. Parkinson, Chief Executive Officer (“ CEO ”); David Wood, Chief Financial Officer (“ CFO ”); Peter Virsik, Executive Vice-President and Chief Operating Officer (“ COO ”); Dr. Frank Perabo, CMO (who resigned from such role effective January 31, 2018); Dr. Marianne Sadar, Director; Dr. Raymond Andersen, Director; Richard Glickman, Director and Chairman of the Board; Gary Sollis, Director; Franklin Berger, Director; Scott Requadt, Director, and Hugo Beekman, Director.

 

During the six months ended March 31, 2018, the Company re-granted, re-priced, and extended the expiry dates of 73,000 (2017 - Nil) options and granted 682,000 (2017 - Nil) options to key management personnel. The vesting of options granted to key management personnel in prior periods was recorded as a share-based payments expense in the statement of income and comprehensive income at a value of $454,650 for the six months ended March 31, 2018 (2017 - $524,360).

 

Included in accounts payable and accrued liabilities as at March 31, 2018 is $387,997 (September 30, 2017 - $219,031) due to related parties with respect to key management personnel compensation and expense reimbursements. Amounts due to related parties are non-interest bearing, with no fixed terms of repayment.

 

Dr. Parkinson, CEO, is entitled to a payment of one year of base salary upon termination without cause after 12 months of employment. This amount increases to 18 months if the termination without cause occurs after a change of control event or within 60 days prior to a change of control event where such event was under consideration at the time of termination. Mr. Wood, CFO, is entitled to a payment of one year of base salary upon termination without cause, whether or not the termination was caused by a change of control event. Mr. Virsik, COO, is entitled to a payment of six months of base salary upon termination without cause, increasing to one year following one year of employment. This amount increases to 18 months of salary if termination without cause occurs within 18 months after a change of control event. Stock options held by the CEO, CFO, , and COO vest immediately upon a change of control.

 

CHANGES IN OR ADOPTION OF ACCOUNTING POLICIES

 

The accounting policies adopted in the preparation of the condensed consolidated interim financial statements for the six months ended March 31, 2018 and 2017 are detailed in Notes 2 and 3 of the Company’s annual consolidated financial statements for the years ended September 30, 2017, 2016 and 2015:

 

      16

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

New standards not yet adopted

 

IFRS 9 Financial Instruments (Revised)

 

IFRS 9 was issued by the International Accounting Standards Board in October 2010. It incorporates revised requirements for the classification and measurement of financial liabilities and carries over the existing derecognition requirements from IAS 39 Financial Instruments: recognition and measurement. The revised financial liability provisions maintain the existing amortized cost measurement basis for most liabilities. New requirements apply where an entity chooses to measure a liability at fair value through profit or loss. In these cases, the portion of the change in fair value related to changes in the entity's own credit risk is presented in other comprehensive income rather than within profit or loss. IFRS 9 is effective for annual periods beginning on or after January 1, 2018. IFRS 9 is not expected to have a significant impact on the Company’s business, consolidated financial instruments and financial statements.

 

IFRS 15 Revenue from Contracts with Customers

 

IFRS 15 is a new standard to establish principles for reporting the nature, amount, timing, and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. It provides a single model in order to depict the transfer of promised goods or services to customers. IFRS 15 supersedes IAS 11, Construction Contracts, IAS 18, Revenue, IFRIC 13, Customer Loyalty Programs, IFRIC 15, Agreements for the Construction of Real Estate, IFRIC 18, Transfers of Assets from Customers, and SIC-31, Revenue - Barter Transactions involving Advertising Service. IFRS 15 is effective for annual periods beginning on or after January 1, 2018. IFRS 15 is not expected to have a significant impact on the Company’s business, financial instruments and financial statements.

 

IFRS 16 Leases

 

IFRS 16 is a new standard that sets out the principles for recognition, measurement, presentation, and disclosure of leases including guidance for both parties to a contract, the lessee and the lessor. The new standard eliminates the classification of leases as either operating or finance leases as is required by IAS 17 and instead introduces a single lessee accounting model. IFRS 16 is effective for annual periods beginning on or after January 1, 2019. The impact of IFRS 16 on the Company’s business, leases and financial statements has not yet been determined.

 

CRITICAL ACCOUNTING ESTIMATES

 

The Company makes estimates and assumptions about the future that affect the reported amounts of assets and liabilities. Estimates and judgments are continually evaluated based on historical experience and other factors, including expectations of future events, that are believed to be reasonable under the circumstances. In the future, actual experience may differ from these estimates and assumptions.

 

The effect of a change in an accounting estimate is recognized prospectively by including it in comprehensive income in the period of the change, if the change affects that period only, or in the period of the change and future periods, if the change affects both. Significant assumptions about the future and other sources of estimation uncertainty that management has made at the statement of financial position date, that could result in a material adjustment to the carrying amounts of assets and liabilities, in the event that actual results differ from assumptions that have been made, relate to the following key estimates:

Intangible assets - impairment

 

The application of the Company’s accounting policy for intangible assets expenditures requires judgment in determining whether it is likely that future economic benefits will flow to the Company, which may be based on assumptions about future events or circumstances. Estimates and assumptions may change if new information becomes available. If, after expenditures are capitalized, information becomes available suggesting that the recovery of expenditures is unlikely, the amount capitalized is written off in profit or loss in the period the new information becomes available.

 

      17

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

Intangible assets - useful lives

 

Following initial recognition, the Company carries the value of intangible assets at cost less accumulated amortization and any accumulated impairment losses. Amortization is recorded on a straight-line basis based upon management’s estimate of the useful life and residual value. The estimates are reviewed at least annually and are updated if expectations change as a result of technical obsolescence or legal and other limits to use. A change in the useful life or residual value will impact the reported carrying value of the intangible assets resulting in a change in related amortization expense.

 

Product development and relocation grant

 

Pursuant to the terms of the Company’s CPRIT Grant, the Company must meet certain terms and conditions to qualify for the grant funding. The Company has assessed its performance relative to these terms as detailed in the accompanying condensed consolidated interim financial statements for the six months ended March 31, 2018 and 2017 (Note 17 of the accompanying financial statements) and has judged that there is reasonable assurance the Company will meet the terms of the grant and qualify for the remaining funding. The Company has therefore taken into income a portion of the grant that represents expenses the Company has incurred to date under the grant parameters. The expenses are subject to assessment by CPRIT for compliance with the grant regulations which may result in certain expenses being denied and incurred in a future period.

 

Share-based payments and compensation

The Company has applied estimates with respect to the valuation of shares issued for non-cash consideration. Shares are valued at the fair value of the equity instruments granted at the date the Company receives the goods or services.

 

The Company measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. Estimating fair value for share-based payment transactions requires determining the most appropriate valuation model, which is dependent on the terms and conditions of the grant. This estimate also requires determining the most appropriate inputs to the valuation model including the fair value of the underlying common shares, the expected life of the share option, volatility and dividend yield and making assumptions about these inputs. The Company makes reference to prices quoted on the TSX (prior to November 27, 2017) and the TSX-V (following November 27, 2017), as applicable, and Nasdaq. The assumptions and models used for estimating fair value for share-based payment transactions are discussed in Note 10 of the accompanying condensed consolidated interim financial statements. Share-based payments are recorded under R&D and G&A expenditures.

 

Derivative financial instruments

Certain warrants are treated as derivative financial liabilities. The estimated fair value, based on the Black-Scholes model, is adjusted on a quarterly basis with gains or losses recognized in the statement of net loss and comprehensive loss. The Black-Scholes model is based on significant assumptions such as volatility, dividend yield, expected term and liquidity discounts as detailed in Note 8 of the accompanying condensed consolidated interim financial statements. On January 1, 2016, as part of the Company’s functional currency change from the Canadian dollar to the United States dollar, the Company de-recognized a derivative liability on United States dollar-denominated warrants and recognized a new liability on Canadian dollar-denominated warrants; see discussion under the heading “ Selected Quarterly Financial Information - Derivative liabilities .”

 

FINANCIAL INSTRUMENTS AND RISKS

 

The Company’s financial instruments consist of cash, receivables, accounts payable and accrued liabilities, long-term debt and derivative liabilities. Cash is measured based on level 1 inputs of the fair value hierarchy. The fair value of receivables and accounts payable and accrued liabilities approximates their carrying values due to their short term to maturity. The fair value of the SVB Term Loan is approximately $8,734,000 which includes the principal and financing costs assessed on settlement as at March 31, 2018. The derivative liabilities are measured using level 3 inputs. During the six months ended March 31, 2018, the Company recognized a gain on derivative liability of $97,813 (2017 - $1,486,142 loss) through profit or loss.

 

      18

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

Fair value estimates of financial instruments are made at a specific point in time, based on relevant information about financial markets and specific financial instruments. As these estimates are subjective in nature, involving uncertainties and matters of judgement, they cannot be determined with precision. Changes in assumptions can significantly affect estimated fair values.

 

Financial risk factors

The Company’s risk exposures and the impact on the Company’s financial instruments are summarized below:

 

Credit risk

 

Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash and receivables. The Company’s receivables are primarily due to refundable GST and investment tax credits. The Company limits its exposure to credit loss by placing its cash with major financial institutions. Credit risk with respect to investment tax credits and GST is minimal as the amounts are due from government agencies.

 

Liquidity risk

 

The Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities when due. As at March 31, 2018, the Company had working capital of $17,854,975. The SVB Term Loan is repayable over a 33 month period ending September 1, 2020. The Company does not generate revenue and will be reliant on external financing to fund operations and repay the SVB Term Loan. Debt and equity financing is dependent on market conditions and may not be available on favorable terms. The CPRIT grant is dependent on the Company completing all of the contractual obligations thereunder (see the accompanying condensed consolidated interim financial statements for details with respect to the CPRIT Grant terms). In January 2018, the Company completed a financing for total gross proceeds of $26,040,000. The Company believes that, with the proceeds from the January 2018 Financing, the Company has sufficient capital to satisfy its obligations as they become due and execute its planned expenditures through the fiscal 2018 year.

 

Market risk

 

Market risk is the risk of loss that may arise from changes in market factors such as interest rates, and foreign exchange rates.

 

(a)       Interest rate risk

 

As at March 31, 2018, the Company has cash balances which are interest bearing. Interest income is not significant to the Company’s projected operational budget and related interest rate fluctuations are not significant to the Company’s risk assessment.

 

The Company’s SVB Term Loan is interest-bearing debt at a variable rate. A 10% change in the WSJ Prime Rate would result in an increase of $21,705 or decrease of $13,851 in the net loss realized for the period.

 

(b)       Foreign currency risk

 

Historically, the Company’s foreign currency risk exposure relates to net monetary assets denominated in Canadian dollars. A 10% change in the foreign exchange rate between the Canadian and United States dollar would result in a fluctuation of $51,718 in the net loss realized for the period. The Company does not currently engage in hedging activities.

 

(c)       Price risk

 

The Company is exposed to price risk with respect to equity prices. The Company closely monitors individual equity movements and the stock market to determine the appropriate course of action to be taken by the Company.

 

      19

 

Management’s Discussion and Analysis   March 31, 2018

 

 

 

ADDITIONAL INFORMATION

 

Additional information regarding the Company can be found on SEDAR at www.sedar.com, the website of the SEC at www.sec.gov and the Company’s website at www.essapharma.com. The Company’s Annual Report on Form 20-F for the fiscal year ended September 30, 2017 also provides additional information on the Company, and can be accessed through SEDAR at www.sedar.com or the website of the SEC at www.sec.gov.

 

OUTSTANDING SHARE CAPITAL

 

The following table sets out the equity instruments of the Company outstanding as of the date of this MD&A:

 

     
Equity instruments:    
     
Common shares     5,776,098  
Stock options     922,961  
Warrants     2,663,938  

 

RISK FACTORS

 

Prior to making an investment decision investors should consider the investment, operational and intellectual property risks set out in the Company’s second amended and restated prospectus supplement dated January 5, 2018 and the Company’s Annual Report on Form 20-F for the fiscal year ended September 30, 2017, each of which are posted on SEDAR at www.sedar.com and on the SEC’s EDGAR website at www.sec.gov, which are in addition to the usual risks associated with an investment in a business at an early stage of development. The directors of the Company consider the risks set out in the aforementioned amended and restated prospectus supplement and Annual Report on Form 20-F to be the most significant to potential investors in the Company, but are not all of the risks associated with an investment in securities of the Company.

If any of these risks materialize into actual events or circumstances or other possible additional risks and uncertainties of which the directors of the Company are currently unaware, or which they consider not to be material in relation to the Company’s business, actually occur, the Company’s assets, liabilities, financial condition, results of operations (including future results of operations), business and business prospects, are likely to be materially and adversely affected. In such circumstances, the price of the Company’s securities could decline and investors may lose all or part of their investment. The Company’s actual results could differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including the risks described below. See “ Cautionary Note Regarding Forward-Looking Statements.

DISCLOSURE CONTROLS AND PROCEDURES AND

INTERNAL CONTROLS OVER FINANCIAL REPORTING

 

Disclosure Controls and Procedures (“DC&P”)

 

The Company has established disclosure controls and procedures to ensure that information disclosed in this MD&A and the related condensed consolidated interim financial statements was properly recorded, processed, summarized and reported to the Company’s Board and Audit Committee. The Company’s certifying officers conducted or caused to be conducted under their supervision an evaluation of the disclosure controls and procedures as required under Canadian securities laws, as at September 30, 2017. Based on the evaluation, the Company’s certifying officers concluded that the disclosure controls and procedures were effective to provide a reasonable level of assurance that information required to be disclosed by the Company in its annual filings, interim filings, and other reports that it files or submits under Canadian securities legislation is recorded, processed, summarized and reported within the time period specified and that such information is accumulated and communicated to the Company’s management, including the certifying officers, as appropriate to allow for timely decisions regarding required disclosure.

 

      20

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

It should be noted that while the Company’s certifying officers believe that the Company’s disclosure controls and procedures provide a reasonable level of assurance and that they are effective, they do not expect that the disclosure controls and procedures will prevent all errors and fraud. A control system, no matter how well conceived or operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

Internal Control over Financial Reporting (“ICFR”)

The Company’s certifying officers acknowledge that they are responsible for designing internal controls over financial reporting, or causing them to be designed under their supervision in order to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS. As at September 30, 2017, the Company’s certifying officers conducted or caused to be conducted under their supervision an evaluation of the design and operating effectiveness of the Company’s internal control over financial reporting, as required under Canadian securities laws. Based on such evaluation, the Company’s certifying officers concluded that the Company’s internal control over financial reporting was effective.

The Company ceased to be a venture issuer, as defined by National Instrument (“ NI ”) 51-102 - Continuous Disclosure Obligations on July 9, 2015 as a result of completing its listing on the Nasdaq . The Company’s Audit Committee is comprised of Franklin Berger (chair), Richard Glickman, and Gary Sollis, all of whom are “financially literate” as defined in NI 52-110 - Audit Committees (“ NI 52-110 ”) and the rules of Nasdaq . Each member of the Audit Committee is considered independent pursuant to NI 52-110, Rule 10A-3 under the United States Securities and Exchange Act of 1934, as amended, and the rules of Nasdaq . The Company’s Board has determined that Mr. Berger is an “audit committee financial expert” as defined in Item 16A of Form 20-F.

Management has adopted the internal control framework of the Committee of Sponsoring Organizations of the Treadway Commission Internal Control - Integrated Framework (2013).

The Company did not have any significant changes to its ICFR systems in the period from January 1, 2018 to March 31, 2018 that materially affected, or are reasonably likely to materially affect the Company’s ICFR.

Limitations of Controls and Procedures

The Company’s management, including the CEO and CFO, believe that any disclosure controls and procedures or internal controls over financial reporting, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, they cannot provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been prevented or detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by unauthorized override of the control. The design of any systems of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Accordingly, because of the inherent limitations in a cost effective control system, misstatements due to error or fraud may occur and not be detected.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This MD&A contains forward-looking statements or forward-looking information within the meaning of the United States Private Securities Litigation Reform Act and applicable Canadian securities laws. All statements in this MD&A, other than statements of historical facts, are forward-looking statements. These statements appear in a number of different places in this MD&A and can be identified by words such as “anticipates”, “estimates”, “projects”, “expects”, “intends”, “believes”, “plans”, “will”, “could”, “may”, “hopes” or their negatives or other comparable words. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Examples of such forward looking statements include, but are not limited to statements related to:

 

      21

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

the initiation, timing, cost, location, progress and success of, strategy and plans with respect to, ESSA’s research and development programs (including research programs and related milestones with regards to next-generation drug candidates and compounds), preclinical studies and clinical trials;
the therapeutic benefits, properties, effectiveness, pharmacokinetic profile and safety of the Company’s potential future product candidates, including the expected benefits, properties, effectiveness, pharmacokinetic profile and safety of the Company’s next-generation Aniten compounds;
Dr. Perabo’s departure from the Company as Chief Medical Officer and continuing involvement with the Company in an advisory capacity;
the Company’s ability to advance its potential future product candidates through, and successfully complete, clinical trials;
the Company’s ability to achieve profitability;
the Company’s ability to obtain funding for operations, including research funding, and the timing of potential sources of such funding;
the CPRIT Grant and payments thereunder;
the Company’s use of proceeds from funding and financings;
the Company’s ability to recruit sufficient numbers of patients for future clinical trials, and the benefits expected therefrom;
the implementation of the Company’s business model and strategic plans, including strategic plans with respect to patent applications and strategic collaborations partnerships;
the Company’s ability to identify, develop and commercialize product candidates;
the Company’s commercialization, marketing and manufacturing capabilities and strategy;
the Company’s expectations regarding federal, state, provincial and foreign regulatory requirements, including the Company’s plans with respect to anticipated regulatory filings;
whether the Company will receive, and the timing and costs of obtaining, regulatory approvals in the United States, Canada and other jurisdictions;
the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by the Company’s potential future product candidates;
the rate and degree of market acceptance and clinical utility of the Company’s potential future product candidates, if any;
the timing of, and the Company’s ability and the Company’s collaborators’ ability, if any, to obtain and maintain regulatory approvals for the Company’s potential future product candidates;
the Company’s expectations regarding market risk, including interest rate changes and foreign currency fluctuations;
the Company’s ability to engage and retain the employees required to grow its business;
the compensation that is expected to be paid to the Company’s employees;
the Company’s future financial performance and projected expenditures;
developments relating to the Company’s competitors and its industry, including the success of competing therapies that are or may become available; and
estimates of the Company’s financial condition, expenses, future revenue, capital requirements, its needs for additional financing and potential sources of capital and funding.

 

Such statements reflect the Company’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including those described under “Risk Factors”. In making the forward looking statements included in this MD&A, the Company has made various material assumptions, including but not limited to:

its ability to identify a product candidate or product candidates;
its ability to obtain regulatory and other approvals to commence a clinical trial involving future product candidates;
its ability to obtain positive results from its R&D activities, including clinical trials;
its ability to obtain required regulatory approvals;

 

      22

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

its ability to successfully out-license or sell future products, if any, and in-license and develop new products;
favourable general business and economic conditions;
the availability of financing on reasonable terms;
its ability to attract and retain skilled staff;
market competition;
the products and technology offered by the Company’s competitors;
its ability to protect patents and proprietary rights; and
its ability to repay debt.

 

In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors, including the risks outlined under the heading “ Risk Factors ” in the Company’s Annual Report on Form 20-F for the fiscal year ended September 30, 2017. Some of these risks and assumptions include, among others:

 

uncertainty as to the Company’s ability to raise additional funding;
the Company’s ability to continue as a going concern;
the Company’s incurrence of significant losses in every quarter since its inception and anticipation that it will continue to incur significant losses in the future;
risks related to raising additional capital, which may include dilution to the Company’s existing shareholders, restrictions on the Company’s operations or requirements to relinquish rights to ESSA’s technologies or any future product candidates;
the Company’s limited operating history;
risks related to the Company's ability to comply with the CPRIT Agreement;
uncertainty as to the Company’ ability to generate sufficient cash to service its indebtedness, which currently consists of its capital term loan facility with Silicon Valley Bank;
the Company’s ability to identify a product candidate through preclinical studies;
the Company’s future success is dependent primarily on identification through preclinical studies, regulatory approval, and commercialization of a single product candidate;
risks related to the Company’s ability to continue to license its product candidates or technology from third parties;
uncertainty related to the Company’s ability to obtain required regulatory approvals for ESSA’s proposed products;
the Company’s ability to successfully develop potential future product candidates in a timely manner;
the Company's ability to successfully commercialize future product candidates;
the possibility that the Company’s potential future product candidates may have undesirable side effects:
risks related to clinical drug development;
risks related to the Company’s ability to conduct a clinical trial or submit a future NDA/NDS or IND/CTA (each, as defined herein);
risks related to the Company’s ability to enroll subjects in clinical trials;
risks that the FDA (as defined herein) may not accept data from trials conducted in such locations outside the United States;
risks related to the Company’s ongoing obligations and continued regulatory review;
risks related to potential administrative or judicial sanctions;
the risk of increased costs associated with prolonged, delayed or terminated clinical trials;
risks related to the Company’s failure to obtain regulatory approval in international jurisdictions;
risks related to recently enacted and future legislation in the United States that may increase the difficulty and cost for the Company to obtain marketing approval of, and commercialize, its potential future products and affect the prices the Company may obtain;
risks related to new legislation, new regulatory requirements, and the continuing efforts of governmental and third party payors to contain or reduce the costs of healthcare;
the risk that third parties may not carry out their contractual duties;
the possibility that the Company’s relationships with CROs (as defined herein) may terminate;
risks related to the Company’s lack of experience manufacturing product candidates on a large clinical or commercial scale and its lack of manufacturing facility;
the Company’s reliance on proprietary technology;

 

      23

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

the Company may not be able to protect its intellectual property rights throughout the world;
claims by third parties asserting that the Company, or its employees have misappropriated their intellectual property, or claiming ownership of what the Company regards as its intellectual property;
risks related to the Company's ability to manage growth;
risks related to the Company’s ability to attract and maintain highly-qualified personnel;
risks related to potential conflicts of interest between the Company and its directors and officers;
competition from other biotechnology and pharmaceutical companies;
risks related to movements in foreign currency exchange rates;
third-party coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain the Company’s future revenues;
risks related to the Company’s ability to convince public payors and hospitals to include ESSA’s potential future products on their approved formulary lists;
risks related to the Company’s ability to establish an effective sales force and marketing infrastructure, or enter into acceptable third-party sales and marketing or licensing arrangements;
risks related to the Company’s ability to achieve or maintain expected levels of market acceptance for its products;
risks related to the Company’s ability to realize benefits from acquired businesses or products or form strategic alliances in the future;
risks related to collaborations with third parties;
risks that employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for ESSA and harm its reputation;
risks related to product liability lawsuits;
risks related to computer system failures;
business disruptions that could seriously harm the Company’s future revenues and financial condition and increase ESSA’s costs and expenses;
compulsory licensing and/or generic competition;
risks related to the Company’s dependence on the use of information technologies;
risks related to the increased costs and effort as a result of ESSA becoming a public company;
risks inherent in foreign operations;
laws and regulations governing international operations may preclude the Company from developing, manufacturing and selling certain product candidates outside of the United States and Canada and require ESSA to develop and implement costly compliance programs;
risks related to laws that govern fraud and abuse and patients' rights;
risks related to the Company’s ability to comply with environmental, health and safety laws and regulations;
risks related to the different disclosure obligations for a U.S. domestic reporting company and a foreign private issuer such as ESSA;
risks relating to the Company’s ability to maintain its status as a foreign private issuer in the future;
the risk that the Company could become a “passive foreign investment company;”
risks related to the Company’s status as an emerging growth company;
risks related to United States investors' ability to effect service of process or enforcement of actions against the Company;
risks related to the Company's dividend policy;
risks associated with future sales of the Company’s securities;
risks related to the Company’s ability to implement and maintain effective internal controls;
risks related to the Company's ability to maintain an active trading market for its Common Shares;
share price volatility associated with the Company’s thinly traded common shares;
risks related to market price and trading volume volatility; and
risks related to analyst coverage.

 

      24

 

Management’s Discussion and Analysis   March 31, 2018
 

 

 

If one or more of these risks or uncertainties or a risk that is not currently known to the Company, materialize, or if its underlying assumptions prove to be incorrect, actual results may vary significantly from those expressed or implied by forward-looking statements. The forward-looking statements represent the Company’s views as of the date of this document. While the Company may elect to update these forward-looking statements in the future, the Company has no current intention to do so except as to the extent required by applicable securities law. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements. The Company advises you that these cautionary remarks expressly qualify in their entirely all forward-looking statements attributable to the Company or persons acting on its behalf.

 

      25

 

Exhibit 99.3

 

Form 52-109FV2

Certification of Interim Filings

Venture Issuer Basic Certificate

 

I, David R. Parkinson, Chief Executive Officer of ESSA Pharma Inc., certify the following:

1. Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of ESSA Pharma Inc. (the “Issuer”) for the interim period ended March 31, 2018.

 

2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the Issuer, as of the date of and for the periods presented in the interim filings.

 

Date: May 14, 2018

 

 

“David R. Parkinson”

David R. Parkinson

Chief Executive Officer

 

NOTE TO READER

 

In contrast to the certificate required for non-venture issuers under National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings (NI 52-109), this Venture Issuer Basic Certificate does not include representations relating to the establishment and maintenance of disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as defined in NI 52-109. In particular, the certifying officers filing this certificate are not making any representations relating to the establishment and maintenance of

 

i) controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

ii) a process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

The issuer’s certifying officers are responsible for ensuring that processes are in place to provide them with sufficient knowledge to support the representations they are making in this certificate. Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement on a cost effective basis DC&P and ICFR as defined in NI 52-109 may result in additional risks to the quality, reliability, transparency and timeliness of interim and annual filings and other reports provided under securities legislation.

Exhibit 99.4

 

Form 52-109FV2

Certification of Interim Filings

Venture Issuer Basic Certificate

 

I, David Wood, Chief Financial Officer of ESSA Pharma Inc., certify the following:

1. Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of ESSA Pharma Inc. (the “Issuer”) for the interim period ended March 31, 2018.

 

2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.

 

3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the Issuer, as of the date of and for the periods presented in the interim filings.

 

Date: May 14, 2018

 

 

“David Wood”

David Wood

Chief Financial Officer

 

NOTE TO READER

 

In contrast to the certificate required for non-venture issuers under National Instrument 52-109 Certification of Disclosure in Issuers’ Annual and Interim Filings (NI 52-109), this Venture Issuer Basic Certificate does not include representations relating to the establishment and maintenance of disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as defined in NI 52-109. In particular, the certifying officers filing this certificate are not making any representations relating to the establishment and maintenance of

 

i) controls and other procedures designed to provide reasonable assurance that information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and

 

ii) a process to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP.

 

The issuer’s certifying officers are responsible for ensuring that processes are in place to provide them with sufficient knowledge to support the representations they are making in this certificate. Investors should be aware that inherent limitations on the ability of certifying officers of a venture issuer to design and implement on a cost effective basis DC&P and ICFR as defined in NI 52-109 may result in additional risks to the quality, reliability, transparency and timeliness of interim and annual filings and other reports provided under securities legislation.

Exhibit 99.5

 

   

 

 

 

ESSA Pharma Provides Corporate Update and Reports Financial Results for

Fiscal Second Quarter Ended March 31, 2018

 

Houston, Texas and Vancouver, Canada, May 14, 2018 - ESSA Pharma Inc. (“ESSA” or the “Company”) (TSX-V: EPI, NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today provided a corporate update and reported financial results for the fiscal second quarter ended March 31, 2018. All references to “$” in this release refer to United States dollars, unless otherwise indicated.

 

“Following the successful close of our $26 million financing in early 2018, we have made significant advances toward our clinical objective of developing more potent next-generation aniten compounds,” said President and CEO, David R. Parkinson. “We expect to nominate a next-generation clinical candidate in 2018, and to file an Investigational Drug Application in the first half of calendar 2019.”

 

Corporate Update

 

· Further enhanced in vitro potency and reduced metabolism in order to select a potential clinical candidate.

 

o Generated compounds with significant improvements in both potency and stability as compared to first-generation aniten N-terminal domain inhibitor compound, EPI-506.

 

Completed $26 million financing to fund preclinical and clinical development within next-generation aniten program.

 

Regained compliance with the Nasdaq Captial Market’s (the “Nasdaq’s”) minimum bid price requirement and the Company is now in compliance with all applicable listing standards and ESSA’s common stock will continue to be listed on the Nasdaq.

 

Appointed a representative of investor Omega Funds, a life sciences-focused venture capital firm, to the Company’s board of directors.

 

Hired senior professionals in the areas of preclinical drug development, chemistry, manufacturing, and control.

 

Summary Financial Results

Effective April 25, 2018, the Company consolidated its issued and outstanding common shares on the basis of one post-consolidation share for every 20 pre-consolidation shares. The consolidation applied to all ESSA common shares, prepaid warrants, and other securities convertible into or exercisable for common shares. Unless otherwise stated, all ESSA common share and per share amounts have been restated retrospectively to reflect this share consolidation.

 

· Net Income (Loss) . ESSA recorded a net loss of $4.4 million ($0.83 loss per common share based on 5,287,608 weighted average common shares outstanding) for the quarter ended March 31, 2018, compared to a net loss of $7.6 million ($0.15 loss per common share based on 1,454,844 weighted average common shares outstanding) for the quarter ended March 31, 2017.

 

· Research and Development (“R&D”) expenditures. R&D expenditures for the quarter ended March 31, 2018, were $2.0 million (net of grants and gross), compared to $2.5 million net of grants ($3.7 million gross) for the quarter ended March 31, 2017. For the quarter ended March 31, 2018, decreases in R&D expenditures were primarily related to decreases in manufacturing and clinical trial costs as the Company had concluded its Phase I clinical study of EPI-506 in September 2017, compared to the quarter ended March 31, 2017, during which ESSA was conducting the EPI-506 clinical trial and incurring associated development costs. The EPI-506 clinical trial commenced in November 2015.

 

 
 

· General and administration (“G&A”) expenditures. G&A expenditures for the quarter ended March 31, 2018, were $2.2 million, compared to $1.4 million for the quarter ended March 31, 2017. This increase primarily reflected increased corporate activity, as well as compensation expenses and increased share-based payments reflecting stock option grants in the quarter.

 

Liquidity and Outstanding Share Capital

Cash on hand at March 31, 2018, was $21.7 million, with working capital of $17.9 million, reflecting the aggregate gross proceeds of the financing, totaling $26 million, completed in January 2018.

 

As of March 31, 2018, the Company had 5,776,098 common shares issued and outstanding, and 2,189,000 common shares issuable on the exercise of prepaid warrants at $0.002. If all prepaid warrants are exercised, there would be approximately 7,965,098 ESSA common shares outstanding.

 

In addition, there were 474,938 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.35 per ESSA common share and 858,461 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.47 per common share.

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 

Contact Information:

 

David Wood

Chief Financial Officer, ESSA Pharma Inc.

Telephone: 778-331-0962

Email: dwood@essapharma.com

 

About ESSA Pharma Inc.

ESSA is a pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer (“CRPC”) in patients whose disease is progressing despite treatment with current therapies. ESSA believes that its proprietary compounds can significantly expand the interval of time in which patients suffering from CRPC can benefit from hormone-based therapies, by disrupting the androgen receptor (“AR”) signaling pathway that drives prostate cancer growth and by preventing AR transcriptional activity by binding selectively to the N-terminal domain (“NTD”) of the AR. A functional NTD is essential for transactivation of the AR. In preclinical studies, blocking the NTD has demonstrated the capability to overcome the known AR-dependent mechanisms of CRPC. ESSA was founded in 2009.

 

About Prostate Cancer

Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2012). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone, disease progression despite castrate levels of testosterone generally represents a transition to the lethal variant of the disease, metastatic CPRC (“mCRPC”), and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those who have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo animal studies, ESSA's novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

 

 
 

 

Forward-Looking Statement Disclaimer               

This release contains certain information which, as presented, constitutes "forward-looking information" within the meaning of the Private Securities Litigation Reform Act of 1995 and/or applicable Canadian securities laws. Forward-looking information involves statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", “potential”, “promising”, “refocus”, statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the acceleration of ESSA’s next-generation NTD-inhibitor aniten compounds and timing of nomination of the next-generation compound and the anticipated timing of the IND filing for the aniten program.

 

Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA’s actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward-looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA’s financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions.

 

Forward-looking information is developed based on assumptions about such risks, uncertainties and other factors set out herein, in the Company’s second amended and restated prospectus supplement dated January 5, 2018 and in ESSA’s Annual Report on Form 20-F dated December 11, 2017 under the heading “Risk Factors”, a copy of which is available on ESSA’s profile on the SEDAR website at www.sedar.com, ESSA’s profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA’s SEDAR profile. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable Canadian and United States securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 

 
 

 

ESSA PHARMA INC.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(Unaudited)

 

Amounts in thousands of United States dollars

 

   

March 31,

2018

  September 30, 2017
         
Cash   $ 21,692     $ 3,957  
Prepaid and other assets     642       1,650  
                 
Total assets   $ 22,334     $ 5,607  
                 
Current liabilities     4,162       3,777  
Long-term debt     4,725       5,933  
Derivative liability     73       171  
Shareholders' deficiency     13,374       (4,274 )
                 
Total liabilities and shareholders’ deficiency   $ 22,334     $ 5,607  

 

ESSA PHARMA INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

Amounts in thousands of United States dollars, except share and per share data

 

    Three months ended March 31, 2018   Three months ended March 31, 2017
         
OPERATING EXPENSES                
Research and development   $ 1,989     $ 2,549  
Financing costs     237       218  
General and administration     2,179       1,364  
                 
Total operating expenses     (4,405 )     (4,131 )
                 
Gain (loss) on derivative liability     9       (3,481 )
Other items     13       1  
                 
Net income (loss) for the period   $ (4,383 )   $ (7,611 )
                 
Basic and diluted earnings (loss) per common share   $ (0.83 )   $ (0.15 )
                 
Weighted average number of common shares outstanding     5,287,608       1,454,844