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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 9.01 | Financial Statements and Exhibits.
(d) Exhibits |
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 |
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.
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.
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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