0001279569-23-001328.txt : 20231023 0001279569-23-001328.hdr.sgml : 20231023 20231023161943 ACCESSION NUMBER: 0001279569-23-001328 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231021 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231023 DATE AS OF CHANGE: 20231023 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ESSA Pharma Inc. CENTRAL INDEX KEY: 0001633932 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37410 FILM NUMBER: 231340192 BUSINESS ADDRESS: STREET 1: SUITE 720 STREET 2: 999 WEST BROADWAY CITY: VANCOUVER STATE: A1 ZIP: V5Z 1K5 BUSINESS PHONE: (778) 331-0962 MAIL ADDRESS: STREET 1: SUITE 720 STREET 2: 999 WEST BROADWAY CITY: VANCOUVER STATE: A1 ZIP: V5Z 1K5 8-K 1 form8k.htm FORM 8-K
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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): October 21, 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 8.01 Other Events.

On October 21, 2023, the Company issued a press release announcing the presentation of updated dose escalation data from its Phase 1/2 study evaluating Masofaniten (formerly known as EPI-7386) in combination with enzalutamide at the European Society of Medical Oncology 2023 Congress. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01Financial Statements and Exhibits.
(d) Exhibits

Exhibit No.

  

Description

99.1

  

Press Release dated October 21, 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)
     
Dated: October 23, 2023 By: /s/ David Wood
    Name: David Wood
    Title: Chief Financial Officer

 

 EX-99.1 2 ex991.htm PRESS RELEASE DATED OCTOBER 21, 2023

EXHIBIT 99.1

 

 

 

 

ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the European Society of Medical Oncology 2023 Congress

 

Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC

 

Across all cohorts of patients including those recently enrolled into cohort four, 69% of patients achieved PSA90, 63% of patients achieved PSA90 in less than 90 days, and 56% of patients achieved PSA <0.2mg/mL

 

SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Oct. 21, 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 announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the European Society of Medical Oncology (ESMO) 2023 Congress, taking place October 20-24, 2023, in Madrid, Spain. Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the ESMO Digital Program and in the "Publications" section of the Company's website at www.essapharma.com.

 

“The dose escalation data presented at ESMO this year continue to demonstrate that the combination of masofaniten and enzalutamide is well tolerated and results in deep and durable reductions in prostrate-specific antigen (“PSA”) in patients with metastatic castration-resistant prostate cancer (“mCRPC”),” said David Parkinson, MD, President and CEO of ESSA. “While the data for patients in cohort four are not yet mature, we are highly encouraged by the PSA responses seen thus far in the cohort and in the study as a whole. We look forward to further elucidating the potential clinical benefit of this combination in the randomized Phase 2 portion of the study which is currently underway.”

 

Poster presentation details:

 

Title: Phase 1/2 Trial of Oral EPI-7386 (masofaniten) in Combination with Enzalutamide (Enz) Compared with Enz Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC): Current Phase 1 (P1) results

Presenting Author: Andrew Laccetti, MD, MS, Memorial Sloan Kettering Cancer Center
Abstract # 1813P

Date: Sunday, October 22, 2023

 

Data summary: This Phase 1/2 multicenter, open-label clinical trial is enrolling patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today are from the first four cohorts of patients in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.

 

  1 

 

 

In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the doses tested through 21 cycles of dosing in some patients. Most frequent adverse events were Grade 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related.

 

In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). In the first three cohorts, 90% of patients (9 of 10) achieved PSA50 and PSA90, 80% of patients (8 of 10) achieved PSA90 in less than 90 days, and 70% of patients (7 of 10) achieved PSA <0.2mg/mL. Across all dose cohorts including patients in the recently enrolled cohort four, 88% of patients (14 of 16) achieved PSA50, 69% of patients (11 of 16) achieved PSA90, 63% of patients (10 of 16) achieved PSA90 in less than 90 days, and 56% of patients (9 of 16) achieved PSA <0.2mg/mL. The randomized Phase 2 dose expansion portion of the study is currently enrolling.

 

About Masofaniten

 

Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

 

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 and LinkedIn.

 

  2 

 

 

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 presentations with respect to the Phase 1/2 study, tolerability and PSA reductions in patients with mCRPC, the potential clinical benefit of the combination of masofaniten and enzalutamide, the timing of and enrollment in the Phase 2 portion of the combination study and other statements surrounding the Company's evaluation of masofaniten.

 

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 and on SEDAR+ at www.sedarplus.ca, 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.

 

Contacts

 

ESSA Pharma, Inc.

Peter Virsik, Chief Operating Officer

778.331.0962

pvirsik@essapharma.com

 

Investors and Media:

Argot Partners

212.600.1902

essa@argotpartners.com

 

 

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Cover
Oct. 21, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Oct. 21, 2023
Entity File Number 001-37410
Entity Registrant Name ESSA Pharma Inc.
Entity Central Index Key 0001633932
Entity Tax Identification Number 98-1250703
Entity Incorporation, State or Country Code A1
Entity Address, Address Line One Suite 720
Entity Address, Address Line Two 999 West Broadway
Entity Address, City or Town Vancouver
Entity Address, State or Province BC
Entity Address, Country CA
Entity Address, Postal Zip Code V5Z 1K5
City Area Code 778
Local Phone Number 331-0962
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Shares, no par value
Trading Symbol EPIX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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