Form 8-K - Current report

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): September 18, 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 September 18, 2023, the Company issued a press release announcing the initiation of the Phase 2 portion of its Phase 1/2 study evaluating its lead candidate, masofaniten (formerly known as EPI-7386) in combination with Astellas and Pfizer’s antiandrogen enzalutamide. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01

Financial Statements and Exhibits.
(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated September 18, 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: September 18, 2023
	By:	/s/ David Wood
		Name: David Wood
		Title: Chief Financial Officer

EXHIBIT 99.1

ESSA Pharma Announces Initiation of Phase 2 Study Evaluating Masofaniten (EPI-7386) in Combination with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

Recommended Phase 2 dose regimen identified as masofaniten 600mg BID combined with enzalutamide 160mg QD

Phase 2 head-to-head portion of the study to commence enrollment immediately

Updated Phase 1 results selected for a poster presentation at ESMO 2023

SOUTH SAN FRANCISCO, Calif. and VANCOUVER, Canada, Sept. 18, 2023 /CNW/ - 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 initiation of the Phase 2 portion of its Phase 1/2 study evaluating its lead candidate, masofaniten (formerly known as EPI-7386), a first-in-class N-terminal domain androgen receptor inhibitor, in combination with Astellas and Pfizer's antiandrogen enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens.

Updated results from the first four cohorts of patients from the Phase 1 dose escalation portion of the Phase 1/2 study have been selected for a poster presentation at the upcoming European Society of Medical Oncology ("ESMO") Congress taking place October 20-24, 2023, in Madrid, Spain.

"Initiation of the randomized Phase 2 portion of this study investigating the combination of masofaniten and enzalutamide (the "Combination") is a significant milestone for ESSA and we look forward to reporting updated results from the Phase 1 dose equilibration portion of the study next month at ESMO 2023," stated David Parkinson, M.D., President and CEO of ESSA. "The favorable safety profile observed to date with the Combination has led the safety review board to agree that we can proceed forward into the head-to-head comparison portion of the study with the dose regimen studied in Cohort 4 as our recommended Phase 2 dose. We look forward to further elucidating the Combination's potential to improve long-term clinical benefit for patients with mCRPC. We plan to provide guidance for timing of the public disclosure of initial data once the Phase 2 portion has been underway for several months."

The Phase 2 dose expansion portion of the study is a two-arm, randomized, open-label study (NCT05075577) that will evaluate the safety, tolerability and preliminary efficacy of masofaniten, and is expected to enroll approximately 120 patients. Patients will continue to receive androgen deprivation therapy and will be randomized 2:1 to receive either the combination of masofaniten (600mg twice-daily ("BID")) and enzalutamide (160mg once daily ("QD")) or enzalutamide (160mg QD) as a single agent. Patients may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.

Details for the ESMO 2023 Presentation

Title: Phase 1/2 Trial of Oral EPI-7386 in Combination with Enzalutamide (Enz) Compared to Enz Alone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Subjects: Current Phase 1 (P1) results
Speaker: Andrew L. Laccetti
Presentation #: 1813P
Date: Sunday, October 22, 2023

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.

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 and Phase 1/2 study, the timing of the Phase 2 portion of the combination study, the Combination's potential to improve long-term clinical benefit for patients with mCRPC, the evaluation of the safety, tolerability and preliminary efficacy of masofaniten in the Phase 2 study, enrollment in the Phase 2 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.

Company: Peter Virsik, Chief Operating Officer, ESSA Pharma Inc., Phone: 778.331.0962, Email: pvirsik@essapharma.com; Investors and Media: Argot Partners, 212.600.1902, essa@argotpartners.com

Cover	Sep. 18, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 18, 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