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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): May 9, 2023

 

ESSA Pharma Inc.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada

(State or other jurisdiction of incorporation)

001-37410

(Commission File Number)

98-1250703

(IRS Employer Identification No.)

     

Suite 720, 999 West Broadway, Vancouver, British Columbia, Canada

(Address of principal executive offices)

V5Z 1K5

(Zip Code)

 

Registrant’s telephone number, including area code: (778) 331-0962

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Shares, no par value EPIX Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

The following information is filed pursuant to Item 2.02, “Results of Operations and Financial Condition.”

 

On May 9, 2023, ESSA Pharma Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K.

 

The information provided under this Item (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

 

 

Item 9.01 Financial Statements and Exhibits.
   
  (d) Exhibits

 

Exhibit No.

 

Description

 
99.1   Press Release dated May 9, 2023  
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)  
 

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 hereunto duly authorized.

 

 

 ESSA PHARMA INC.
  (Registrant)
   
Date: May 9, 2023  
By: /s/ David Wood
  Name: David Wood
  Title: Chief Financial Officer
EX-99.1 2 ex991.htm NEWS RELEASE DATED MAY 9, 2023

Exhibit 99.1

 

 

ESSA Pharma Provides Corporate Update and Reports Financial Results for

Fiscal Second Quarter Ended March 31, 2023

 

Entered into clinical trial support agreement with Janssen to supply Erleada® (apalutamide) and Zytiga® (abiraterone acetate) for an ESSA-sponsored Phase 1 study of EPI-7386 combination therapies; enrollment expected to begin 2H2023

 

Continue to enroll patients into the fourth cohort of the Phase 1 EPI-7386 combination study with Xtandi® (enzalutamide); Phase 1 completion expected in 3Q2023 followed by initiation of the randomized Phase 2 part of the study

 

Phase 1b EPI-7386 monotherapy expansion study in mCRPC patients ongoing

 

 

South San Francisco, California and Vancouver, Canada, May 9, 2023 - ESSA Pharma Inc. (“ESSA”, or the “Company”) (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today provided a corporate update and reported financial results for the fiscal second quarter ended March 31, 2023. All references to “$” in this release refer to United States dollars, unless otherwise indicated.

 

“ESSA is in a strong cash position as we execute our clinical strategy to advance our lead candidate, EPI-7386, with our cash runway expected to fund operations and programs through 2025,” stated David Parkinson, MD, President and CEO of ESSA. “This quarter, we continued to enroll patients into our Phase 1 study of EPI-7386 in combination with Xtandi® (enzalutamide), and we are working with clinical sites to prepare for initiation of the randomized Phase 2 portion of the study as soon we complete Phase 1 and select a recommended Phase 2 dose. Our Phase 1 EPI-7386 monotherapy expansion study is progressing as planned with two doses of EPI-7386 currently being tested in advanced metastatic castration-resistant prostate cancer (“mCRPC”) patients. We also advanced an additional EPI-7386 combination therapy program through an agreement with Janssen, under which Janssen will supply Erleada® (apalutamide) and Zytiga® (abiraterone acetate) for an ESSA-sponsored and conducted Phase 1 clinical study in multiple prostate cancer patient populations including metastatic hormone-sensitive prostate cancer patients and non-metastatic castration-sensitive prostate cancer patients. We plan to begin testing these new antiandrogen combinations with EPI-7386 in the second half of 2023.”

 

Clinical and Corporate Highlights for the Second Quarter Ended March 31, 2023

 

EPI-7386 Clinical Collaborations

 

The Company continues to enroll patients into the fourth cohort of the Phase 1/2 study of EPI-7386 in combination with enzalutamide in patients with mCRPC naïve to second generation antiandrogens. The Company expects to complete the Phase 1 portion of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the third quarter of 2023, followed by initiation of the Phase 2 part of the study. The open-label, randomized Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended phase 2 doses versus single agent enzalutamide at the standard of care dose. The Phase 2 study is expected to enroll approximately 120 patients.
In April 2023, the Company entered into a clinical trial support agreement with Janssen Research & Development, LLC (“Janssen”) under which Janssen will supply apalutamide and abiraterone acetate for a Phase 1 clinical study sponsored and conducted by ESSA evaluating EPI-7386 combination therapies in two cohorts. The two cohorts will be evaluated as additional cohorts in the Company’s ongoing Phase 1 study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort A will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with mCRPC and high-risk metastatic castration-sensitive prostate cancer. Cohort B is a Window of Opportunity study in which patients with non-metastatic castration-resistant prostate cancer (“nmCRPC”) will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide. ESSA will retain all rights to EPI-7386. The Company expects enrollment to begin in the second half of 2023.

 

EPI-7386 Monotherapy

The Phase 1b EPI-7386 monotherapy dose expansion study is ongoing and is evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on at least one second-generation antiandrogen. The Company is also enrolling nmCRPC patients in the Window of Opportunity cohort of this study, in which patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard of care therapy.

 

Summary Financial Results

Net Loss. ESSA recorded a comprehensive loss of $7.1 million for the first quarter ended March 31, 2023, compared to a comprehensive loss of $10.9 million for the second quarter ended March 31, 2022. For the second quarter ended March 31, 2023, this included non-cash share-based payments of $1.4 million compared to $1.9 million for the prior year, recognized for stock options granted and vesting. The decrease in the second quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $852,347 in interest income.

 

Research and Development (“R&D”) expenditures. R&D expenditures for the second quarter ended March 31, 2023 were $4.5 million compared to $7.6 million for the second quarter ended March 31, 2022 and include non-cash costs related to share-based payments ($750,159 for the second quarter ended 2023 compared to $1.1 million for the second quarter ended 2022). The decrease in R&D expenditures for the year ended March 31, 2023 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.

 

General and administration (“G&A”) expenditures. G&A expenditures for the second quarter ended March 31, 2023 were $3.7 million compared to $3.8 million for the second quarter ended March 31, 2022 and include non-cash costs related to share-based payments of $686,932 for the second quarter ended 2023 compared to $741,494 for the second quarter ended 2022. The decrease in the second quarter is the result of decreased non-cash share-based payments and professional fees.

 

Liquidity and Outstanding Share Capital

 

At March 31, 2023, the Company had available cash reserves and short-term investments of $157 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of March 31, 2023, the Company had 44,092,374 common shares issued and outstanding.

 

In addition, as of March 31, 2023 there were 2,927,477 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 7,477 warrants at a weighted average exercise price of $42.80. There were 8,045,274 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.08 per common share.

 

 

About ESSA Pharma Inc.

ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com and follow us on Twitter under @ESSAPharma.

 

Forward-Looking Statement Disclaimer               

This release contains certain information which, as presented, constitutes "forward-looking information" within the meaning of the Private Securities Litigation Reform Act of 1995 and/or applicable Canadian securities laws. Forward-looking information involves statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the completion of the Phase 1 EPI-7386 monotherapy study and the Phase 1/2 combination study, enrollment in the monotherapy and combination studies, treatments under the Phase 1b dose expansion study, the Phase 1b Window of Opportunity study and the Phase 1/2 combination study evaluating EPI-7386 with enzalutamide, the initiation of the Phase 2 study, the assessment of anti-tumor activity in the monotherapy and combination studies, the clinical trial support agreement, the supply of apalutamide and abiraterone acetate, the rights to EPI-7386, the testing of new antiandrogen combinations with EPI-7386, the treatments under Cohort A and Cohort B of the Phase 1 clinical trial and the Company’s expected cash runway into 2025.

 

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 10-K dated December 13, 2022 under the heading “Risk Factors”, a copy of which is available on ESSA’s profile on EDGAR at www.sec.gov.com and on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on ESSA’s EDGAR and SEDAR profiles. 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 United States and Canadian securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.

 

 

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS

(Unaudited)

Amounts in thousands of United States dollars

 

  March 31, 2023 September 30, 2022
     
Cash and cash equivalents $ 44,301 $ 57,076
Prepaids and other assets 114,203 112,429
     
Total assets $ 158,504 $ 169,505
     
Current liabilities 2,146 2,310
Long-term debt 20 76
Shareholders' deficiency 156,338 167,119
     
Total liabilities and shareholders’ equity $ 158,504 $ 169,505

 

 

 

 

  

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

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

 

 

 

 

Three months
ended

March 31, 2023

 

Three months
ended

March 31, 2022

 

Six months ended

March 31, 2023

 

Six months ended

March 31, 2022

                 
OPERATING EXPENSES                
Research and development   $ 4,481   $ 7,649   $ 9,825   $ 13,669
Financing costs   2   4   4   8
General and administration   3,731   3,817   6,250   6,880
                 
Total operating expenses   (8,214)   (11,470)   (16,079)   (20,557)
                 
 Gain on derivative liability   -   118   -   18
Interest and other items   1,155   498   2,279   586
                 
Net loss before taxes   (7,059)   (10,854)   (13,800)   (19,953)
Income tax expense (recovery)   (2)   -   (2)   1
                 
Net loss and comprehensive loss for the period  

 

$ (7,061)

 

 

$ (10,854)

 

 

$ (13,802)

 

 

$ (19,952)

                 
Basic and diluted loss per common share  

 

$ (0.16)

 

 

$ (0.25)

 

 

$ (0.31)

 

 

$ (0.45)

                 

Weighted average number of

common shares outstanding

 

 

44,092,374

 

 

44,030,480

 

 

44,082,725

 

 

44,009,903

                       

 

  

Company Contact

 

David Wood, Chief Financial Officer

ESSA Pharma Inc.

Contact: (778) 331-0962

Email: dwood@essapharma.com

Investor Relations Contact:

 

Xuan Yang

Solebury Strategic Communications

Contact: (646) 378-2975

Email: xyang@soleburystrat.com

 

Media Contact:

 

Zara Lockshin

Solebury Strategic Communications

Contact: (646) 378-2960

Email: zlockshin@soleburystrat.com