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 February 2019

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 ☒ 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    
     
99.1   Condensed consolidated interim financials statements for the three months ended December 31, 2018 and 2017
99.2   Form 51-102F1 Management Discussion and Analysis for the three months ended December 31, 2018 and 2017
99.3   Form 52-109FV2 Certification of Interim Filings - Chief Executive Officer
99.4   Form 52-109FV2 Certification of Interim Filings - Chief Financial Officer
99.5   News Release dated February 7, 2019: ESSA Pharma Provides Corporate Update and Reports Financial Rseults for Fiscal First Quarter Ended December 31, 2018.

 

 

 

  This report on Form 6-K shall be incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-225969) and Form S-8 (File No. 333-225056) under the Securities Act of 1933, as amended.

 

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: February 7, 2019   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 THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017

 

 

 

 

 

 

 

 
 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(Unaudited)

(Expressed in United States dollars)

AS AT

    December 31,
2018
  September 30,
2018
         
ASSETS                
                 
Current                
  Cash   $ 12,174,228     $ 14,829,144  
  Receivables (Note 16)     247,575       297,349  
   Prepaids (Note 4)     377,191       470,154  
                 
      12,798,994       15,596,647  
                 
Deposits     201,399       201,399  
Intangible assets (Note 6)     214,454       219,028  
                 
Total assets   $ 13,214,847     $ 16,017,074  
                 
LIABILITIES AND SHAREHOLDERS' EQUITY                
                 
Current                
   Accounts payable and accrued liabilities   $ 738,518     $ 523,669  
   Current portion of long-term debt (Note 7)     2,873,980       2,815,947  
   Income tax payable     –         4,722  
                 
      3,612,498       3,344,338  
                 
Long-term debt (Note 7)     2,817,729       3,501,016  
Derivative liabilities (Note 8)     7,098       19,648  
                 
Total liabilities     6,437,325       6,865,002  
                 
Shareholders' equity                
   Share capital (Note 9)     42,345,997       40,205,997  
   Reserves (Note 10)     13,587,857       15,391,640  
   Accumulated other comprehensive loss     (2,076,479 )     (2,076,479 )
   Deficit     (47,079,853 )     (44,369,086 )
                 
      6,777,522       9,152,072  
                 
Total liabilities and shareholders’ equity   $ 13,214,847     $ 16,017,074  

 

Nature and continuance of operations (Note 1)

Commitments (Note 16)

 

On behalf of the Board on February 6, 2019  
       
“David R. Parkinson” Director “Franklin Berger” Director
       

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

2

 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31

    2018   2017
         
OPERATING EXPENSES                
   Research and development (Note 17)   $ 1,286,323     $ 969,597  
   Financing costs     177,434       244,810  
   General and administration (Note 17)     1,247,108       958,375  
                 
Total operating expenses     (2,710,865 )     (2,172,782 )
                 
   Foreign exchange     (2,800 )     (5,722 )
   Gain on derivative liability (Note 8)     12,550       88,563  
                 
Net loss for the period before taxes     (2,701,115 )     (2,089,941 )
                 
   Income tax expense     (9,652 )     –    
                 
Net loss and comprehensive loss for the period   $ (2,710,767 )   $ (2,089,941 )
                 
Basic and diluted loss per common share   $ (0.43 )   $ (1.44 )
                 

Weighted average number of common shares

outstanding - basic and diluted

    6,305,283       1,455,094  

 

 

 

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

3

 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31

    2018   2017
         
CASH FLOWS FROM OPERATING ACTIVITIES                
   Loss for the period   $ (2,710,767 )   $ (2,089,941 )
   Items not affecting cash:                
     Amortization     4,574       9,972  
     Gain on derivative liability     (12,550 )     (88,563 )
     Finance expense     177,434       244,810  
     Unrealized foreign exchange     (722 )     (18,114 )
     Share-based payments (Note 10)     336,217       88,388  
                 
   Changes in non-cash working capital items:                
     Receivables     53,021       5,967  
     Prepaid expenses     92,963       278,614  
     Accounts payable and accrued liabilities     213,849       (332,030 )
     Income tax payable     (4,722 )     (41,827 )
                 
   Net cash used in operating activities     (1,850,703 )     (1,942,724 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES                
   Loan principal repaid (Note 7)     (683,203 )     –    
   Interest paid (Note 7)     (119,485 )     (146,611 )
                 
   Net cash used in financing activities     (802,688 )     (146,611 )
                 
Effect of foreign exchange on cash     (1,525 )     (27 )
                 
Change in cash for the period     (2,654,916 )     (2,089,362 )
                 
Cash, beginning of period     14,829,144       3,957,185  
                 
Cash, end of period   $ 12,174,228     $ 1,867,823  

 

Supplemental Disclosure with respect to Cash Flows (Note 11)

 

 

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

 

 

 

 

 

 

 

 

4

 

ESSA PHARMA INC.

CONSOLIDATED 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, 2017     1,455,098     $ 25,980,117     $ 4,252,712     $ 309,293     $ (2,076,479 )   $ (32,739,646 )   $ (4,274,003 )
   Share-based payments     –         –         88,388       –         –         –         88,388  
   Loss for the period     –         –         –         –         –         (2,089,941 )     (2,089,941 )
                                                         
Balance, December 31, 2017     1,455,098     $ 25,980,117     $ 4,341,100     $ 309,293     $ (2,076,479 )   $ (34,829,587 )   $ (6,275,556 )
   Financing     4,321,000       17,284,000       –         8,756,000       –         –         26,040,000  
   Share issuance costs     –         (3,058,120 )     –         672,221       –         –         (2,385,899 )
   Share-based payments     –         –         1,313,026       –         –         –         1,313,026  
   Loss for the period     –         –         –         –         –         (9,539,499 )     (9,539,499 )
                                                         
Balance, September 30, 2018     5,776,098     $ 40,205,997     $ 5,654,126     $ 9,737,514     $ (2,076,479 )   $ (44,369,086 )   $ 9,152,072  
   Warrants exercised     535,000       2,140,000       –         (2,140,000 )     –         –         –    
   Share-based payments     –         –         336,217       –         –         –         336,217  
   Loss for the period     –         –         –         –         –         (2,710,767 )     (2,710,767 )
                                                         
Balance, December 31, 2018     6,311,098     $ 42,345,997     $ 5,990,343     $ 7,597,514     $ (2,076,479 )   $ (47,079,853 )   $ 6,777,522  

 

 

 

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

5

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

1.            NATURE AND CONTINUANCE OF OPERATIONS

 

Nature and Continuance 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 December 31, 2018, no products are in commercial production or use. Since September 2017, the Company has been focused on preclinical development of its next-generation compounds. Prior to that, the Company’s primary activity was the Phase I clinical development of clinical candidate EPI-506, which was discontinued on September 11, 2017.

 

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 $2,710,767 during the three months ended December 31, 2018 and has an accumulated deficit of $47,079,853. 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 December 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. Management has forecasted that the Company’s current working capital will not be sufficient to execute its planned expenditures for the coming year. These matters indicate the existence of material uncertainties that raises substantial doubt about the Company’s ability to continue as a going concern.

 

Management continues to seek sources of additional financing which would assure continuation of the Company’s operations and research programs. However, there is no certainty that such financing will be provided or provided on favorable terms. Management believes that it will complete a financing in sufficient time to continue to execute its planned expenditures without interruption.

 

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”).

 

6

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

 

2.            BASIS OF PRESENTATION (cont’d…)

 

Statement of Compliance (cont’d…)

 

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, 2018. The accounting policies and methods of computation applied by the Company in these condensed consolidated interim financial statements are the same as those applied in the Company’s annual financial statements except for those adopted as of October 1, 2018 as described in Note 3.

 

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 Currency

 

The functional currency of an entity is the currency of the primary economic environment in which the entity operates. The functional currency of the Company and its subsidiary has been determined to be the United States dollar.

 

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.

7

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 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 has met certain terms and conditions as detailed in Note 16 to qualify for the grant 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.

 

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).

 

 

 

 

 

 

8

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 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 Toronto Stock Exchange (“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 adopted in the current period

 

IFRS 9 Financial Instruments

 

On October 1, 2018, the Company adopted IFRS 9 Financial Instruments (“IFRS 9”), which was issued by the IASB in October 2010. IFRS 9 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. There was no impact to the Company’s financial instruments resulting from the adoption of IFRS 9.

 

IFRS 15 Revenue from Contracts with Customers

 

On October 1, 2018, the Company adopted IFRS 15 Revenue from Contracts with Customers (“IFRS 15), which 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 did not have an impact on the Company’s financial statements.

 

New standards not yet adopted

 

IFRS 16 Leases

 

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.

 

 

9

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

4.            PREPAID EXPENSES

 

   

December 31,

2018

 

September 30,

2018

         
Prepaid insurance   $ 266,821     $ 381,098  
Other deposits and prepaid expenses     110,370       89,056  
                 
Balance   $ 377,191     $ 470,154  

 

5.            EQUIPMENT

 

    Furniture and fixtures   Computer equipment   Total
             
Cost                        
Balance, September 30, 2017   $ 154,318     $ 43,359     $ 197,677  
     Disposals     (154,318 )     (43,359 )     (197,677 )
Balance, September 30, 2018 and December 31, 2018   $ –       $ –       $ –    
                         
Accumulated Amortization                        
Balance, September 30, 2017   $ 70,539     $ 27,256     $ 97,795  
     Amortization expense     12,567       3,623       16,190  
     Disposals     (83,106 )     (30,879 )     (113,985 )
Balance, September 30, 2018 and December 31, 2018   $ –       $ –       $ –    
                         
Net Book Value                        
Balance, September 30, 2018   $ –       $ –       $ –    
Balance, December 31, 2018   $ –       $ –       $ –    

 

Amortization expense has been recorded in “general and administrative expenses” in the statement of loss and comprehensive loss (Note 17). In the year ended September 30, 2018, the Company disposed of all equipment for $nil proceeds due to office restructuring and recorded a loss on disposal of $83,692.

 

6.            INTANGIBLE ASSETS

 

    NTD Technology
     
Cost        
Balance, September 30, 2017, 2018 and December 31, 2018   $ 361,284  
Accumulated Amortization        
Balance, September 30, 2017   $ 123,958  
   Amortization expense     18,298  
Balance, September 30, 2018   $ 142,256  
   Amortization expense     4,574  
Balance, December 31, 2018   $ 146,830  
         
Net Book Value        
Balance, September 30, 2018   $ 219,028  
Balance, December 31, 2018   $ 214,454  

 

 

10

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

6.            INTANGIBLE ASSETS (cont’d…)

 

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 annual 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. The option to draw an additional $2,000,000 lapsed on July 31, 2017.

 

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 12.15% (2017 - 12.07%).

 

    SVB Term Loan
     
  Balance, September 30, 2017   $ 7,959,680  
Principal repaid     (1,991,378 )
Interest paid     (563,298 )
Accretion     911,959  
         
Balance, September 30, 2018   $ 6,316,963  
Continued…        

 

 

11

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

7.            LONG-TERM DEBT (cont’d…)

 

…continued   SVB Term Loan
     
Balance, September 30, 2018   $ 6,316,963  
Principal repaid     (683,203 )
Interest paid     (119,485 )
Accretion     177,434  
         
Balance, December 31, 2018   $ 5,691,709  
         
Current portion   $ 2,873,980  
Long-term portion   $ 2,817,729  

 

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). As at December 31, 2018, the derivative liability had a fair value of $nil (September 30, 2018 - $nil). The Company has recorded the resulting change in fair value of $nil (2017 - $151) 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 common share of the Company, one 7-year cash and cashless exercise warrant (the “7-Year Warrants”), and one half of one 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.

 

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.

 

12

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

8.            DERIVATIVE LIABILITIES (cont’d…)

 

2016 Warrants (cont’d…)

 

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 December 31, 2018, the 7-Year Warrants derivative liability had a fair value of $6,341 (September 30, 2018 - $17,679). The Company has recorded the resulting change in fair value of $11,338 (2017 - $86,050) 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.

 

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 December 31, 2018, the SVB Warrants derivative liability had a fair value of $757 (September 30, 2018 - $1,969). The Company has recorded the resulting change in fair value of $1,212 (2017 - $2,362) in the statement of loss and comprehensive loss.

 

Valuation

 

The Company uses the Black-Scholes option pricing model to estimate fair value. The following weighted average assumptions were used to estimate the fair value of the derivative warrant liabilities on September 30, 2017, September 30, 2018 and December 31, 2018:

 

    December 31,
2018
  September 30,
2018
  September 30,
2017
             
Risk-free interest rate     2.57 %     3.06 %     1.78 %
Expected life     4.04 years       4.29 years       3.67 years  
Expected annualized volatility     65.1 %     68.0 %     74.2 %
Dividend     –         –         –    

 

13

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 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 $1,992 as at December 31, 2018. If the market price were to decrease by a factor of 10% this would decrease the obligation by approximately $1,733 as at December 31, 2018. If the volatility were to increase by 10%, this would increase the obligation by approximately $6,839 as at December 31, 2018. If the volatility were to decrease by 10%, this would decrease the obligation by approximately $4,131 as at December 31, 2018.

 

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

 

    Total
     
Balance, September 30, 2017   $ 170,743  
Change in fair value     (151,095 )
         
Balance, September 30, 2018   $ 19,648  
Change in fair value     (12,550 )
         
Balance, December 31, 2018   $ 7,098  
         
Derivatives with expected life of less than one year   $ –    
Derivatives with expected life greater than one year   $ 7,098  

 

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.

 

January 2018 Financing

 

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 $810,500 including $211,073 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.

 

 

14

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

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

 

January 2018 Financing (cont’d…)

 

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 $18,599, 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.

 

Nomination Rights

 

In connection with a January 2016 private placement of 227,273 Units, a Unit consisting of one common share, one 7-year warrant and one-half of one 2-year warrant, of the Company, Clarus Lifesciences III, L.P. (“ Clarus ”) acquired 106,061 common shares. Clarus is entitled to nominate two directors 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 Clarus holds greater than or equal to 53,030 common shares, subject to adjustment in certain circumstances.

 

In connection with the January 2018 Financing, Omega Fund IV, L.P. (“ Omega ”) acquired 465,000 common shares and 535,000 pre-funded warrants (exercised subsequent to year end). 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. These nomination rights will continue for so long as Omega holds at least 9.99% of the issued and outstanding common shares.

 

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.

 

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 December 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.

 

 

15

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

10.          RESERVES (cont’d…)

 

Stock options

 

Stock option transactions are summarized as follows:

 

    Number
of Options
  Weighted
Average
Exercise Price*
         
Balance, September 30, 2017     185,876     $ 44.53  
Options granted     803,400       3.94  
Options expired/forfeited     (88,817 )     (21.83 )
                 
Balance, September 30, 2018     900,459     $ 4.80  
Options granted     12,000       3.58  
Options expired/forfeited     (498 )     (4.00 )
                 
Balance outstanding, December 31, 2018     911,961     $ 4.79  
Balance exercisable, December 31, 2018     208,728     $ 7.68  

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

 

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

 

Exercise price

 

Number of options

Weighted average remaining contractual life (years)  
         
$   3.58 12,000 9.81  
$   4.00 572,250 8.93  
$   4.10 12,500 9.46  
C$   4.90 286,000 8.81  
C$ 16.00 250 0.38  
C$ 40.00 28,961 0.82  
    911,961 8.65  

 

Share-based compensation

 

During the three months ended December 31, 2018, the Company granted a total of 12,000 (2017 - nil) stock options with a weighted average fair value of $3.22 per option (2017 - $nil).

 

During the year ended September 30, 2018, the Company amended the exercise prices and expiry dates of 83,350 outstanding stock options to exercise prices of either C$4.90 or $4.00 and expiry dates ranging from October 1, 2023 to August 9, 2026. This resulted in additional share-based payments expense of $78,747 for the year ended September 30, 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%.

 

 

 

 

 

 

16

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

 

10.          RESERVES (cont’d…)

 

Share-based compensation (cont’d…)

 

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 expense (Note 17)   $ 90,052     $ (5,459 )
General and administrative (Note 17)     246,165       93,847  
    $ 336,217     $ 88,388  

 

The following weighted average assumptions were used for the Black-Scholes option-pricing model valuation of stock options granted:

 

    2018   2017
         
Risk-free interest rate     2.89 %     –    
Expected life of options     10.00 years       –    
Expected annualized volatility     84.10 %     –    
Dividend     –         –    

 

Warrants

 

Warrant transactions are summarized as follows:

 

    Number
of Warrants
  Weighted
Average
Exercise Price*
         
Balance, September 30, 2017     349,635     $ 65.38  
   Warrants granted     2,427,937       0.40  
   Warrants expired     (113,636 )     66.00  
                 
Balance, September 30, 2018     2,663,936     $ 6.13  
   Warrants exercised     (535,000 )     (0.002 )
                 
Balance outstanding and exercisable, December 31, 2018     2,128,936     $ 7.66  

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

 

 

 

 

 

 

 

 

17

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

 

 

10.          RESERVES (cont’d…)

 

Warrants (cont’d…)

 

At December 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
  7,476   US$42.80   November 18, 2023
  1,653,999 (2) US$0.002   January 9, 2023
  175,938   US$4.00   January 9, 2023
  63,000   US$4.00   January 16, 2023
  2,128,936        

 

(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 three months ended December 31, 2018, the Company issued 535,000 common shares upon the exercise of 535,000 pre-funded warrants issued in connection with the January 2018 Financing (Note 9).

 

During the three months ended December 31, 2017, the Company accrued $209,844 in deferred financing costs through accounts payable and accrued liabilities.

 

12.          RELATED PARTY TRANSACTIONS

 

Key management personnel of the Company include the President and Chief Executive Officer, Executive VP and Chief Operating Officer, Chief Financial Officer, Chief Technical Officer, Chief Scientific Officer, former Chief Medical 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   $ 397,897     $ 672,387  
Share-based payments, net of cancellations (a)     286,806       93,760  
Total compensation   $ 684,703     $ 766,147  

(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 three months ended December 31, 2018, the Company granted 12,000 (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 $286,806 (2017 - $93,760).

 

Included in accounts payable and accrued liabilities at December 31, 2018 is $98,553 (September 30, 2018 - $128,035) 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.

 

18

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

 

12.          RELATED PARTY TRANSACTIONS (cont’d…)

 

Commitments

 

The CEO is entitled to a payment of one year of base salary upon termination without cause. 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 one year of base salary upon termination without cause. 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, 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 was 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 favorable 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.

 

There were no changes to the Company’s approach to capital management during the three months ended December 31, 2018. As at December 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. The fair value of cash, 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 $6,051,252 which includes the principal and financing costs assessed on settlement as at December 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.

 

 

 

 

 

 

19

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 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 December 31, 2018, the Company had a working capital of $9,223,478. 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 are dependent on market conditions and may not be available on favorable terms.

 

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 December 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 $7,202 or decrease of $8,409 in the net loss realized for the period.

 

(b)       Foreign currency risk

 

The Company’s foreign currency risk exposure relates to net monetary assets denominated in Canadian dollars. The Company maintains its cash in US dollars and converts on an as needed basis to discharge Canadian denominated expenditures. A 10% change in the foreign exchange rate between the Canadian and U.S. dollar would result in a fluctuation of $3,453 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.

 

 

 

 

 

20

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

 

16.          COMMITMENTS

 

Product Development and Relocation Grant

 

In February 2014 the Company received notice that it had been awarded a product development and relocation grant by 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 has been recorded as a receivable as at September 30, 2018 and December 31, 2018.

 

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 fails to maintain the required level of operations in the State of Texas for three years following the final payment of grant funds, then the Company could be 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 the Company receives from sale of commercial product or commercial service, 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.

 

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

 

Contractual obligations   2019   2020   2021   2022   2023
                     
Minimum annual royalty per License Agreement (Note 6)   C$

 

85,000

    C$

 

85,000

    C$

 

85,000

    C$

 

85,000

    C$

 

85,000

 
Collaborative Research Agreement with BC Cancer Agency     174,037       –         –         –         –    
                                         
Total (in C$)   C$ 259,037     C$ 85,000     C$ 85,000     C$ 85,000     C$ 85,000  
                                         
SVB loan payments (Note 7)   $ 2,408,064     $ 4,032,332     $ –       $ –       $ –    
Lease on US office spaces   $ 87,358     $ 119,383     $ 70,670     $ –       $ –    
                                         

 

 

 

 

 

 

 

21

ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017 

 

 

 

 

 

17.          EXPENSES BY NATURE

 

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

 

For the three months ended December 31   2018   2017
         
Clinical   $ –       $ 156,557  
Consulting     74,331       309,237  
Legal patents and license fees     273,536       122,566  
Manufacturing     1,312       93,415  
Other     6,240       1,645  
Pharmacology     –         42,699  
Preclinical     657,861       –    
Research grants and administration     –         79,593  
Salaries and benefits     178,403       162,592  
Share-based payments (Note 10)     90,052       (5,459 )
Travel     4,588       6,752  
                 
Total   $ 1,286,323     $ 969,597  

 

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

 

For the three months ended December 31   2018   2017
         
Amortization   $ 4,574     $ 9,972  
Consulting and subcontractor fees     26,165       18,907  
Director fees     63,000       47,750  
Insurance     114,278       114,834  
Investor relations     41,287       44,854  
Office, IT and communications     14,526       25,624  
Professional fees     249,473       93,602  
Regulatory fees and transfer agent     16,995       20,238  
Rent     42,915       110,869  
Salaries and benefits     371,309       355,296  
Share-based payments (Note 10)     246,165       93,847  
Travel and entertainment     56,421       22,582  
                 
Total   $ 1,247,108     $ 958,375  

 

 

22

 

Exhibit 99.2

 

 

 

 

 

 

 

 

 

FORM 51-102F1

MANAGEMENT’S DISCUSSION AND ANALYSIS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ESSA Pharma Inc.

900 West Broadway, Suite 720

Vancouver, BC

V5Z 1K5

Canada

ESSA Pharmaceuticals Corp.

1001 Texas Ave., Suite 1400

Houston, TX

77002

USA

 

 

 

Management’s Discussion and Analysis

December 31, 2018

 

 

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

 

This management’s discussion and analysis (“ MD&A ”) of ESSA Pharma Inc. (the “ Company ” or “ ESSA ”) for the three months ended December 31, 2018 and 2017 is dated as of February 6, 2019.

 

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 three months ended December 31, 2018 and 2017 and the audited consolidated financial statements for the years ended September 30, 2018, 2017 and 2016, 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 December 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”.

 

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:

the Company’s ability to obtain funding for operations, including research funding, and the timing of potential sources of such funding;
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;
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 grant (“ CPRIT Grant ”) under the Cancer and Prevention Research Institute of Texas (“ CPRIT ”) and payments thereunder, including residual obligations;
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 Company’s ability to establish and maintain relationships with collaborators with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts;
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;
  i

Management’s Discussion and Analysis

December 31, 2018

 

 

the Company’s commercialization, marketing and manufacturing capabilities and strategy;
the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others;
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;
the availability of financing on reasonable terms;
its ability to repay debt;
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 research and development activities, including clinical trials;
its ability to obtain required regulatory approvals;
its ability to protect patents and proprietary rights;
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;
its ability to attract and retain skilled staff;
market competition; and
the products and technology offered by the Company’s competitors.

 

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, 2018. Some of these risks and assumptions include, among others:

uncertainty as to the Company’s ability to raise additional funding;
risks related to the Company’s ability to raise additional capital on favorable terms;
uncertainty as to the Company’ ability to generate sufficient cash to service its indebtedness;
risks that the Company may default on the residual obligations of the agreement providing for the CPRIT Grant, which may result in the Company not receiving the remaining CPRIT Grant funds and/or having to reimburse all of the CPRIT Grant, if such default is not waived by CPRIT;
  ii

Management’s Discussion and Analysis

December 31, 2018

 

 

risks related to the Company’s ability to continue as a going concern;
risks related to the Company’s incurrence of significant losses in every quarter since its inception and the Company’s anticipation that it will continue to incur significant losses in the future;
risks related to the Company’s limited operating history;
risks related to the Company’s ability to identify a product candidate through preclinical studies and obtain regulatory approval of an IND application to commence a clinical trial;
risks related to the Company’s future success being 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;
risks related to the Company’s ability to successfully identify and develop potential future product candidates in a timely manner;
risks related to 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 future 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;
risks related to the possibility that the Company’s relationships with academic institutions and 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;
the Company may not be able to protect its intellectual property rights throughout the world;
risks related to 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 comply with governmental patent agency requirements in order to maintain patent protection;
risks related to computer system failures or security breaches;
risks related to business disruptions that could seriously harm the Company’s future revenues and financial condition and increase ESSA’s costs and expenses;
risks related to the Company’s dependence on the use of information technologies;
risks related to the Company’s ability to attract and maintain highly-qualified personnel;
third-party coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain the Company’s future revenues;
risks related to potential conflicts of interest between the Company and its directors and officers;
risks related to competition from other biotechnology and pharmaceutical companies;
risks related to movements in foreign currency exchange rates;
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;
  iii

Management’s Discussion and Analysis

December 31, 2018

 

 

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 manage growth;
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 compulsory licensing and/or generic competition;
risks related to the increased costs and effort as a result of ESSA being 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 ability to maintain compliance with Nasdaq listing requirements;
risks related to market price and trading volume volatility;
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;
risks related to share price volatility associated with the Company’s thinly traded common shares; and
risks related to analyst coverage.

 

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.

 

OVERVIEW OF THE COMPANY

 

ESSA is a pharmaceutical company currently in preclinical stage 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

  iv

Management’s Discussion and Analysis

December 31, 2018

 

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, which interfere either with androgen synthesis, or with the binding of androgens to the ligand-binding domain (“ LBD ”), 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 and therefore androgen-driven biology. 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. A recently completed Phase I clinical trial of ESSA’s first-generation agent EPI-506 (as defined herein) demonstrated prostate-specific antigen (“ PSA ”) declines, a sign of inhibition of AR-driven biology, 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 that block the binding of androgens (enzalutamide, apalutamide or bicalutamide) to the AR, or inhibit synthesis of androgens (abiraterone). More recently, important results have been achieved by utilizing this latest generation of anti-androgens in combination with ADT in newly diagnosed metastatic prostate cancer.

 

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 block 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 more completely 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 as patients 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 29% being observed in some patients highly refractory to current anti-androgens. However, unlike in animals, this first-generation drug was significantly metabolized in humans, leading to a very short half-life of circulating drug. Consequently, very 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 focusing on the development of the next generation of Anitens. The Company is now focused on developing this next generation, including more potent drugs with potentially increased resistance to metabolism as well as improved pharmaceutical properties, including expected improvements to manufacturability, stability and likelihood of successful commercial formulation.

  5

Management’s Discussion and Analysis

December 31, 2018

 

 

 

The NTD of the 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 specifically 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 and the subsequent safety profile in the Phase 1 trial.

 

The incidence of both metastatic and non-metastatic CRPC continues to rise, and using a dynamic progression model, Scher et al have projected a 2020 incidence of 546,955 and prevalence of 3,072,480. 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 or apalutamide.

 

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 initial series of compounds, including EPI-506. The Company licensed the original 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 world-wide rights to the issued patents and patent applications in respect of the EPI-series compounds, including the next generation Aniten compounds.

 

The Company believes that it has developed a strong and defensive intellectual property position for multiple EPI and Aniten structural classes, with 18 patent families filed, covering different structural motifs/analogues.

 

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 between 2034-2038.

 

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 (“ mCRPC ”) 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, EPI-506 dosing was escalated aggressively to allow patients in the clinical study greater exposure to the drug. 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.

 

 

 

Scher HI, Solo K, Valant J, Todd MB, Mehra M (2015) Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLoS ONE 10(10): e0139440. doi:10.1371/journal.pone.0139440

 

 

  6

Management’s Discussion and Analysis

December 31, 2018

 

 

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.

 

ESSA’s next-generation Aniten compounds represent chemical scaffold changes to the first-generation drugs and appear to retain 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 in vitro assays measuring inhibition of AR transcriptional activity, these drugs demonstrate greater than 10 times higher potency than EPI-506 or its active metabolite, EPI-002. In addition, the compounds demonstrate resistance to metabolism in preclinical studies, is indicative of longer half-lives in humans. Lastly, the compounds demonstrate significantly improved pharmaceutical properties relative to EPI-506. They represent potential improvements in ease and cost of large-scale manufacture, drug product stability, and suitability for commercialization globally. The Aniten program is currently in the final stages of IND lead-selection with IND and CTA filings expected to occur an estimated nine to twelve months after a candidate is nominated.

 

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 ultimately 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, in parallel the Company is also conducting preclinical studies of combination therapy with academic and industry collaborators.

 

  7

Management’s Discussion and Analysis

December 31, 2018

 

 

 

 

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 the generation of a new series of compounds that have demonstrated higher potency and predicted longer half-lives. 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 greater than 10 times higher potency than EPI-002. Considerable progress has been made towards making a final IND candidate selection. Our current estimate is that a final IND candidate will be selected in the first quarter of calendar 2019, with the filing of an IND with the FDA and a CTA with Health Canada expected an estimated nine to twelve months thereafter.

 

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 mCRPC patients. Depending on the number of cohorts enrolled, the Phase I clinical trial is expected to take nine to twelve months. At this time, it is expected that the design of the Phase I clinical trial will be the standard three patients per dose cohort. All patients will be characterized biologically for underlying tumor genomic charactistics, for evidence of AR pathway activation and for dose-related pharmacological and pharmacodynamic effects. 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, timing and clinical as well as biological characteristics of the patients to be entered into 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 AR, vARs 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.

 

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 three months ended December 31, 2018, the Company recorded a comprehensive loss of $2,710,767 (2017 - $2,089,941). As of December 31, 2018, the Company had cash resources of $12,174,228 (September 30, 2018 - $14,829,144) and working capital of $9,186,496 (September 30, 2018 - $12,252,309).

  8

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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. 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 three months ended December 31, 2018 and for the subsequent period to the date of this MD&A.

 

Corporate and Finance Highlights

 

Exercise of Pre-Funded Warrants

 

On October 1, 2018, the Company issued 535,000 common shares to Omega Fund IV, L.P. upon the exercise of 535,000 pre-funded warrants originally issued in an equity financing in January 2018.

 

Change to the Company’s Board of Directors

 

On October 18, 2018, Dr. Otello Stampacchia of Omega Fund Management, LLC, was appointed to the board of directors of the Company; concurrently, the Company granted 12,000 stock options, exercisable at $3.58 per share for a period of ten years, to Dr. Stampacchia in relation to his appointment.

 

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:

First milestone: 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.
Second milestone: the filing and approval with respect to the selected candidate 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 have resulted in increased potency in an in vitro AR-based gene transcription assay, exhibiting greater than 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. This next-generation compound also inhibited in vitro cellular proliferation of an enzalutamide-resistant cell line.

  9

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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 could lead to unanticipated toxicity. Broad characterization of these compounds has demonstrated minimal non-specific binding properties in this off-target screening, indicating a favorable selectivity profile for further development. The most promising of these next-generation compounds are in the final stages of preclinical characterization, as required to select a final IND candidate.

 

Future Clinical Development Program

Phase I/II Clinical Trial Design for treating CRPC patients

 

If the Company successfully identifies a clinical candidate and approval of any IND or CTA, 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.

 

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 ultimately obtain full regulatory approval, the Company expects that at least one Phase III clinical trial will be required, most likely in patients similar to the population of mCRPC 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.

 

 

 

 

  10

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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 December 31, 2018.

 

For the Quarters Ended

   

 

December 31,

2018

 

 

September 30,

2018

 

 

June 30,

2018

 

 

March 31,

2018

                 
Total assets   $ 13,214,847     $ 16,017,074     $ 18,512,377     $ 22,334,083  
Long-term liabilities     2,824,827       3,520,664       4,134,529       4,797,841  
Research and development expense     1,286,323       926,839       987,792       1,989,107  
General and administration     1,247,108       1,211,159       1,579,420       2,179,717  
Comprehensive loss   $ (2,710,767 )   $ (2,276,430 )   $ (2,880,113 )   $ (4,382,956 )
Basic loss per share     (0.43 )     (0.39 )     (0.50 )     (0.83 )
Diluted loss per share     (0.43 )     (0.39 )     (0.50 )     (0.83 )

 

For the Quarters Ended

   

 

December 31,

2017

 

 

September 30,

2017

 

 

June 30,

2017

 

 

March 31,

2017

                 
Total assets   $ 3,433,234     $ 5,607,044     $ 8,405,965     $ 13,738,990  
Long-term liabilities     5,421,942       6,103,835       7,105,830       15,931,442  
Research and development expense     969,597       1,165,917       2,920,181       2,548,761  
General and administration     958,375       1,105,295       1,302,314       1,363,493  
Comprehensive income (loss)   $ (2,089,941 )   $ (1,945,299 )   $ 3,592,404     $ (7,610,579 )
Basic income (loss) per share     (1.44 )     (1.34 )     2.47       (5.23 )
Diluted income (loss) per share     (1.44 )     (1.34 )     2.32       (5.23 )

 

The Company’s quarterly results have varied and may, in the future, vary depending on numerous factors, including the rate of expenditure relative to financial capacity and operational plans, the status and 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 March 31, 2017 and September 30, 2018, the Company recorded the partial receipts of the third tranche of the CPRIT Grant of $1,200,000, and $229,201, respectively, which were recognized as recoveries of R&D expenditures. The CPRIT Grant is detailed in the accompanying condensed consolidated interim financial statements and risks relating to the CPRIT Grant, including risk that the Company may default on the residual obligations of the agreement providing for the CPRIT Grant, are described under the heading “ Risk Factors ” in the Company’s Annual Report on Form 20-F for the fiscal year ended September 30, 2018, which is available on SEDAR at www.sedar.com and on the EDGAR website at www.sec.gov.

 

In the quarter ended March 31, 2018, the Company completed the January 2018 Financing (as defined below) for gross proceeds of approximately $26,040,000 resulting in an increase in assets.

 

  11

Management’s Discussion and Analysis

December 31, 2018

 

 

 

Three months ended December 31, 2018 and 2017

 

The Company incurred a comprehensive loss of $2,710,767 for the three months ended December 31, 2018 compared to a comprehensive loss of $2,089,941 for the three months ended December 31, 2017.

 

Other significant changes in comprehensive loss are as follows:

 

Research and Development

The overall Research and Development (“ R&D ”) expense for the three months ended December 31, 2018 was $1,286,323 compared to $969,597 for the three months ended December 31, 2017. R&D expense in 2018 was incurred primarily in preclinical research on the Company’s next-generation Aniten compounds, which commenced in September 2017. R&D expense in 2017 also includes the costs of winding down the EPI-506 Phase I clinical trial, which was terminated in September 2017, and associated chemistry, manufacturing and controls (“ CMC ”) costs.
Consulting fees were $74,331 for the three months ended December 31, 2018 compared to $309,237 for the three months ended December 31, 2017 and include amounts paid to the Chief Scientific Officer (“ CSO ”) and Chief Technical Officer (“ CTO ”) for monthly consulting fees and bonuses pursuant to consulting agreements - see “ Related Party Transactions ” below. The prior period also included R&D consultants working on the winding down of the EPI-506 Phase I clinical trial, which was terminated in September 2017.

 

Legal patents and license fees have increased to $273,536 for the three months ended December 31, 2018 compared to $122,566 for the three months ended December 31, 2017. The increase is due to the Company’s patent applications on its next-generation compounds as compared to the prior period which included the abandonment of the family of patents related to EPI-506 in relation to the Company’s termination of the clinical trial in September 2017. The Company has submitted a number of patent applications for which the Company owns the rights. 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.

 

Clinical costs of $nil (2017 - $156,557), manufacturing costs of $1,312 (2017 - $93,415), and pharmacology costs of $nil (2017 - $42,699) for the three months ended December 31, 2018 have decreased as a result of the Company’s winding down of the EPI-506 Phase I clinical trial, which was terminated in September 2017.

 

Preclinical costs of $657,861 (2017 - $nil) for the three months ended December 31, 2018 were incurred in the development of the Company’s next-generation Aniten compounds. In the three months ended December 31, 2017, preclinical costs were primarily incurred internally and under the collaborative research agreements with the BCCA and UBC - see discussion for Research grants and administration costs below.

 

Research grants and administration costs were $nil (2017 - $79,593) for the three months ended December 31, 2018. Research grants and administration costs in 2017 relate to amounts payable pursuant to collaborative research agreements with the BCCA and UBC. Amounts incurred vary in relation to timing of milestone payments pursuant to such agreements.
Salaries and benefits have increased to $178,403 (2017 - $162,592) for the three months ended December 31, 2018 as a result of increased preclinical and clinical staff involved in the development of the Company’s next-generation Aniten compounds.

 

  12

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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

 

For the three months ended December 31

  2018   2017
         
Clinical   $ –       $ 156,557  
Consulting     74,331       309,237  
Legal patents and license fees     273,536       122,566  
Manufacturing     1,312       93,415  
Other     6,240       1,645  
Pharmacology     –         42,699  
Preclinical     657,861       –    
Research grants and administration     –         79,593  
Salaries and benefits     178,403       162,592  
Share-based payments (Note 10*)     90,052       (5,459 )
Travel     4,588       6,752  
                 
Total   $ 1,286,323     $ 969,597  

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

 

Share-based payments of $90,052 (2017 - $5,459 recovery) for the three months ended December 31, 2018 relate to the value assigned to stock options granted to key management and consultants of the Company conducting research and development activities. The expense is recognized in relation to the grant and vesting of these equity instruments as measured by the Black-Scholes pricing model.

 

General and administrative

 

General and administration expenses for the three months ended December 31, 2018 increased to $1,247,108 from $958,375 in the comparative period in 2017. Significant components of such expenses in the current period included:

Director fees of $63,000 (2017 - $47,750) were incurred in relation to various meetings held by the board of directors of the Company (the “ Board ”) and various committees during the period; fees in the current period were paid to five directors, compared to four directors in the prior period.

 

Investor relations expense of $41,287 (2017 - $44,854) was incurred in relation to investor relations consultants, shareholder communications and news releases.

 

Professional fees for legal and accounting services of $249,473 (2017 - $93,602) were incurred in conjunction with the corporate activities in the current period, including additional preparatory work on financing strategy and the Company’s annual regulatory filings. Professional fees incurred in the prior period ended December 31, 2017 were related to the January 2018 Financing and were recorded as deferred costs.

 

Rent expense has decreased to $42,915 (2017 - $110,869) as a result of reduced costs related to relocation to more cost-effective office space in Houston in June 2018.

 

Salaries and benefits expense has increased to $371,309 (2017 - $355,296) due to corporate staffing such as the Chief Executive Officer, Chief Financial Officer, and Chief Operating Officer, as disclosed under the heading “Related Party Transactions”, and additional general administrative support staff.

 

Insurance expense of $114,278 (2017 - $114,834) relates to insurance coverage for directors and officers of the Company as a reporting issuer and publicly listed company in the United States, as well as general liability insurance.
  13

Management’s Discussion and Analysis

December 31, 2018

 

 

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

 

For the three months ended December 31

  2018   2017
         
Amortization   $ 4,574     $ 9,972  
Consulting and subcontractor fees     26,165       18,907  
Director fees     63,000       47,750  
Insurance     114,278       114,834  
Investor relations     41,287       44,854  
Office, IT and communications     14,526       25,624  
Professional fees     249,473       93,602  
Regulatory fees and transfer agent     16,995       20,238  
Rent     42,915       110,869  
Salaries and benefits     371,309       355,296  
Share-based payments (Note 10*)     246,165       93,847  
Travel and entertainment     56,421       22,582  
                 
Total   $ 1,247,108     $ 958,375  

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

 

Share-based payments expense of $246,165 (2017 - $93,847) relates to the value assigned to stock options granted to key management and consultants of the Company. The expense is recognized in relation to the grant and vest of these equity instruments as measured by the Black-Scholes pricing model.

Derivative liabilities

 

The Company has certain warrants treated as derivatives for financial reporting purposes. Consequently, the Company’s financial results are impacted by fluctuations in the market price of the Company’s common stock. These warrants, as well as some broker warrants, are measured at fair value, with changes recognized in the statement of loss and comprehensive loss at each reporting date. During the three months ended December 31, 2018, the Company recorded the resulting change in fair value, largely resulting from the decrease in stock price during the period, of $12,550 (2017 - $88,563) 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 three months ended December 31, 2018 and 2017.

 

USE OF PROCEEDS

 

The Company did not complete any financings during the three months ended December 31, 2018.

 

During the year ended September 30, 2018, the Company received total net proceeds of $23,654,101 from an equity financing of 4,321,000 common shares and 2,189,000 pre-funded warrants at a price of $4.00 each, for total gross proceeds $26,040,000 (the “ January 2018 Financing ”).

 

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.

  14

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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 three months ended December 31, 2018, the Company incurred $1,196,271 in cash R&D costs 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 $996,369 has been incurred for cash general and administrative costs in support of the Company’s research and development activities. The Company also completed $683,203 and $119,485 in principal and interest payments, respectively, on the a capital term loan with Silicon Valley Bank (the “SVB Term Loan”), pursuant to which the Company has currently drawn down $8,000,000.

 

During the year ended September 30, 2018, the Company incurred $4,873,335 in cash 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 $5,928,671 has been incurred for cash general and administrative costs in support of the Company’s research and development activities. The Company also completed $1,991,378 and $563,298 in principal and interest payments, respectively, on the SVB Term Loan.

 

As at December 31, 2018, the Company has not yet fully expended the funds raised in its January 2018 Financing towards the preclinical development of its next-generation Aniten compounds.

 

LIQUIDITY AND CAPITAL RESOURCES

 

As at December 31, 2018, the Company has working capital of $9,186,496 (September 30, 2018 - $12,252,309). Operational activities during the three months ended December 31, 2018 were financed mainly by proceeds from the January 2018 Financing. At December 31, 2018, the Company had available cash reserves of $12,174,228 (September 30, 2018 - $14,829,144) and accounts receivable of $247,575 (September 30, 2018 - $297,349) related primarily to the final CPRIT Grant payment and GST input tax credits, to settle current liabilities of $3,612,498 (September 30, 2018 - $3,344,338). The Company believes that it will require additional funds to satisfy its obligations as they become due and execute its planned expenditures through the fiscal 2019 year, including the funding of a Phase 1 clinical study of a next-generation Aniten compound and to meet obligations under the SVB Term Loan.

 

Cash used in operating activities for the three months ended December 31, 2018 was $1,850,703 (2017 - $1,942,724). Working capital items provided cash by $318,129 (2017 - $89,276 cash used).

 

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

 

Cash used in financing activities for the three months ended December 31, 2018 was $802,688 (2017 - $146,611), including $683,203 (2017 - $nil) and $119,485 (2017 - $146,611) in principal and 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 ”).

  15

Management’s Discussion and Analysis

December 31, 2018

 

 

 

CONTRACTUAL OBLIGATIONS

 

As of December 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   2019   2020   2021   2022   2023   After 5 years
                         
Minimum annual royalty per License Agreement (CAD) (1)   C$ 85,000     C$ 85,000     C$ 85,000     C$ 85,000     C$ 85,000     C$ 680,000  
Collaborative Research Agreement with BCCA (CAD)     174,037       –         –         –         –         –    
                                                 
Total (in CAD)   C$ 259,037     C$ 85,000     C$ 85,000     C$ 85,000     C$ 85,000     C$ 680,000  
Total (in USD) (2)   $ 190,016     $ 62,352     $ 62,352     $ 62,352     $ 62,352     $ 498,814  
                                                 
SVB loan payments (USD)   $ 2,408,064     $ 4,032,332     $ –       $ –       $ –       $ –    
Lease on U.S. office spaces (USD)   $ 87,358     $ 119,383     $ 70,670     $ –       $ –       $ –    
                                                 
Total (USD)   $ 2,685,438     $ 4,214,067     $ 133,022     $ 62,352     $ 62,352     $ 498,814  
                                                 

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 = $0.7336 as at December 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.

 

  16

Management’s Discussion and Analysis

December 31, 2018

 

 

 

 

 

 

RELATED PARTY TRANSACTIONS

 

Compensation accrued and paid to key management personnel for the three months ended December 31, 2018 and 2017 was as follows:

 

 

Name and Relationship

 

 

Nature of compensation

 

 

2018

 

 

2017

             
Richard Glickman, Director and Chairman of the Board   Director fees (1)   $ 16,500     $ 13,500  
Gary Sollis, Director   Director fees (1)     12,750       9,750  
Franklin Berger, Director   Director fees (1)     12,750       9,750  
Scott Requadt, Director   Director fees (1)     11,750       8,750  
Dr. Otello Stampacchia, Director   Director fees (1)(2)     9,250       –    
Dr. Marianne Sadar, Director and Chief Scientific Officer   Consulting fees and bonus (3)     34,626       165,463  
Dr. Raymond Andersen, Director and Chief Technical Officer   Consulting fees and bonus (4)     34,626       90,453  
Dr. David R. Parkinson, Chief Executive Officer   Salary and bonus (5)     112,940       109,650  
David Wood, Chief Financial Officer   Salary and bonus (6)     58,718       58,611  
Peter Virsik, Executive Vice-President and Chief Operating Officer   Salary and bonus (7)     93,987       91,250  
Dr. Frank Perabo, former Chief Medical Officer   Salary and bonus (8)     –         111,843  
Directors and officers   Share-based payments (9)     286,806       259,400  
Total compensation       $ 684,703     $ 928,420  

 

Notes:

(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) Amounts are payable to Omega Funds Management LLC, a company in which Dr. Stampacchia is the Managing Director.
(3) 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) for the first and second year of the term and an annual consulting fee of C$120,000 (C$10,000 monthly) for the third and fourth year of the term. Dr. Sadar is also 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) 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) for the first and second year of the term and an annual consulting fee of C$120,000 (C$10,000 monthly) for the third and fourth year of the term. Dr. Andersen is also eligible for a bonus of up to 25% of the annual consulting fee upon accomplishment of certain objectives as agreed upon by all parties.
(5) 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.
(6) David Wood receives a base salary of $236,900 per annum and a performance-based bonus per annum of up to 40% of his base salary.
(7) 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.
  17

Management’s Discussion and Analysis

December 31, 2018

 

 

(8) 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 but remains with the Company in an advisory capacity.
(9) 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, Dr. Otello Stampacchia, Director (appointed October 18, 2018), and Hugo Beekman, Director (who resigned from such role effective May 30, 2018).

 

During the three months ended December 31, 2018, the Company granted 12,000 (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 $286,806 for the three months ended December 31, 2018 (2017 - $ 259,400).

 

Included in accounts payable and accrued liabilities as at December 31, 2018 is $98,553 (September 30, 2018 - $128,035) due to Richard Glickman, Gary Sollis, Franklin Berger, Scott Requadt, and Omega Funds Management, LLC 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. 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 one year of base salary upon termination without cause. 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 three months ended December 31, 2018 and 2017 are consistent with those policies detailed in Notes 2 and 3 of the Company’s annual consolidated financial statements for the years ended September 30, 2018, 2017 and 2016, except for the following:

 

IFRS 9 Financial Instruments

 

On October 1, 2018, the Company adopted IFRS 9 Financial Instruments (“IFRS 9”), which was issued by the IASB in October 2010. IFRS 9 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. There was no impact to the Company’s financial instruments resulting from the adoption of IFRS 9.

 

IFRS 15 Revenue from Contracts with Customers

 

On October 1, 2018, the Company adopted IFRS 15 Revenue from Contracts with Customers (“IFRS 15), which 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 did not have an impact on the Company’s financial statements.

  18

Management’s Discussion and Analysis

December 31, 2018

 

 

New standards not yet adopted

 

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.

 

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 has met certain terms and conditions to qualify for the grant 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.

 

  19

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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. The fair value of cash, 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 $6,051,252 which includes the principal and financing costs assessed on settlement as at December 31, 2018. The SVB Term Loan bears an interest rate of the Wall Street Journal 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, due upon the earlier of the maturity or the termination of the SVB Term Loan. The SVB Term Loan contains a voluntary prepayment option whereby the principal amount can be prepaid in whole or in part. 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 defaults in the event of a material adverse change. There are no financial covenants under the SVB Term Loan. The derivative liabilities are measured using level 3 inputs. During the three months ended December 31, 2018, the Company recognized a gain on derivative liability of $12,550 (2017 - $88,563) through profit or loss.

 

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:

 

 

  20

Management’s Discussion and Analysis

December 31, 2018

 

 

 

 

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 December 31, 2018, the Company had working capital of $9,186,496. 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. Management continues to seek sources of additional financing which would assure continuation of the Company’s operations and research programs. However, there is no certainty that such financing will be provided or provided on favorable terms. Management plans to complete a financing in sufficient time to continue to execute its planned expenditures without interruption.

 

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 December 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 $7,202 or decrease of $8,409 in the net loss realized for the period.

 

(b)       Foreign currency risk

 

The Company’s foreign currency risk exposure relates to net monetary assets denominated in Canadian dollars. The Company maintains its cash in US dollars and converts on an as needed basis to discharge Canadian denominated expenditures. A 10% change in the foreign exchange rate between the Canadian and U.S. dollar would result in a fluctuation of $3,453 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.

 

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, 2018 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.

 

 

  21

Management’s Discussion and Analysis

December 31, 2018

 

 

 

 

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     6,311,098  
Stock options     911,961  
Warrants     2,128,936  

 

RISK FACTORS

 

Prior to making an investment decision investors should consider the investment, operational and intellectual property risks set out in the Company’s Annual Report on Form 20-F for the fiscal year ended September 30, 2018, which is 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 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 above. 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 December 31, 2018. 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.

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.

  22

Management’s Discussion and Analysis

December 31, 2018

 

 

 

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 December 31, 2018, 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 October 1, 2018 to December 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.

  23

 

 

 

 

 

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 December 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: February 7, 2019

 

 

“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 December 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: February 7, 2019

 

 

“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 First Quarter Ended December 31, 2018

HOUSTON and VANCOUVER, Feb. 7, 2019 /CNW/ - 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 first quarter ended December 31, 2018. All references to "$" in this release refer to United States dollars, unless otherwise indicated. 

"Following the preclinical work on a select group of our next generation aniten compounds showing high potency, metabolic stability, predicted long half-lives and superior pharmaceutical properties we are on track to make a final IND candidate selection in the first calendar quarter of 2019, and enter the clinic as expeditiously as possible after our IND submission," stated David Parkinson, MD, President and CEO of ESSA. "We look forward to presenting two posters at the 2019 Genitourinary Cancers Symposium on February 14, 2019, which will be the first public presentation of preclinical data from ESSA's new aniten compounds."

Recent Company Highlights

Summary Financial Results

Liquidity and Outstanding Share Capital
Cash on hand at December 31, 2018, was $12.2 million, with working capital of $9.2 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, , which totalled $26 million, less operating expenses in the intervening period.

As of December 31, 2018, the Company had 6,311,098 common shares issued and outstanding, and 1,654,000 common shares issuable on the exercise of prepaid warrants at a nominal exercise price of $0.002 per common share. If all prepaid warrants are exercised, there would be approximately 7,965,098 ESSA common shares outstanding.

In addition, as of December 31, 2018 there were 474,937 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 911,961 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.79 per common share.

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.

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's proprietary "aniten" compounds bind to the N-terminal domain of the androgen receptor ("AR"), inhibiting AR-driven transcription and the AR signaling pathway in a unique manner which bypasses the drug resistance mechanisms associated with current anti-androgens. The Company is currently completing IND-enabling studies on a small number of next generation compounds with higher potency and metabolic stability, longer half-life and superior pharmaceutical properties to the first generation NTD inhibitor.  ESSA intends to make a final IND candidate selection in Q1 2019 following full compound selectivity characterization and in vivo animal model results.

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 "look forward", "anticipate" and, "believe", and statements that an action or event "is expected", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding timing of identifying the next-generation aniten product candidate, presenting at the ASCO-GU, the ACCR Annual Meeting and the Roth Conference, and the anticipated timing of submitting an IND application and entering the clinic.

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 and in ESSA's Annual Report on Form 20-F dated December 13, 2018 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.

ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(Unaudited)
Amounts in thousands of United States dollars
  December
31, 2018
  September
30, 2018
 
         
Cash $ 12,174   $ 14,829  
Prepaid and other assets 1,041   1,188  
         
Total assets $ 13,125   $ 16,017  
         
Current liabilities 3,575   3,344  
Long-term debt 2,818   3,501  
Derivative liability  7   20  
Shareholders' deficiency 6,815   9,152  
         
Total liabilities and shareholders' deficiency $ 13,215   $ 16,017  

 

ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Amounts in thousands of United States dollars, except share and per share data
      Three months ended
December 31, 2018
  Three months ended
December 31, 2017
           
OPERATING EXPENSES          
Research and development     $ 1,249   $ 970
Financing costs     177   245
General and administration     1,247   958
           
Total operating expenses     (2,673)   (2,173)
           
Gain (loss) on derivative liability     13   89
Other items     (3)   (6)
           
Net income (loss) before taxes     (2,663)   (2,090)
Income tax expense     (10)   -
           
Net income (loss) for the period     $ (2,673)   $ (2,090)
           
Basic and diluted earnings (loss)
per common share
    $ (0.42)   $ (1.44)
           

Weighted average number of

common shares outstanding

    6,305,283   1,455,094

 

SOURCE ESSA Pharma Inc

 

View original content: http://www.newswire.ca/en/releases/archive/February2019/07/c2334.html

%CIK: 0001633932

For further information: Company Contact: David Wood, Chief Financial Officer, ESSA Pharma Inc., Contact: (778) 331-0962, Email: dwood@essapharma.com; Investor Relations Contact: Alan Lada, Vice President, Solebury Trout, Contact: (617) 221-8006, Email : ALada@SoleburyTrout.com

CO: ESSA Pharma Inc

CNW 17:05e 07-FEB-19