SOUTH
SAN FRANCISCO, Calif. and VANCOUVER, Canada, May 10, 2022
/PRNewswire/ - 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, 2022. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"During this past quarter, we continued to dose patients in our
Phase 1 monotherapy study of EPI-7386, a first-in-class N-terminal
domain ("NTD") androgen receptor inhibitor, in patients with
metastatic castration-resistant prostate cancer
("mCRPC") whose tumors have progressed on current
standard-of-care therapies," stated David
Parkinson, M.D., President and CEO of ESSA. "We expect to
present a clinical update on the monotherapy trial in the first
half of 2022. In addition, several clinical collaborations are
underway investigating the potential clinical benefit of EPI-7386
in combination with approved second-generation antiandrogens,
including the Company-sponsored Phase 1/2 study of EPI-7386 in
combination with enzalutamide in mCRPC patients who have not yet
been treated with second-generation antiandrogen therapies."
Clinical and Corporate Highlights
EPI-7386 Monotherapy
- The Company is currently dosing patients in the Phase 1a dose
escalation study evaluating EPI-7386 as a monotherapy in patients
with mCRPC. Patients are being dosed at 1,000 mg QD, 800 mg/day
administered as 400 mg twice daily (BID) and 1200 mg/day
administered as 600 mg BID.
- The Company expects to provide a clinical update on the Phase
1a dose escalation study in the first half of 2022.
- The Phase 1b study is expected to
commence in the second half of 2022 and will confirm a recommended
Phase 2 dose ("RP2D").
EPI-7386 Clinical Collaborations
- In January 2022, the Company
dosed the first patient in the Company-sponsored Phase 1/2 study of
EPI-7386 in combination with Astellas Pharma Inc.'s and Pfizer
Inc.'s enzalutamide in patients with mCRPC who have not been
treated with second-generation antiandrogen therapies.
- Janssen Research and Development LLC has initiated a Phase 1/2
trial of EPI-7386 in combination with apalutamide or abiraterone
acetate plus prednisone in earlier line mCRPC patients.
- The Bayer-led Phase 1/2 trial will evaluate EPI-7386 in
combination with darolutamide in earlier line mCRPC patients.
Preclinical
- On April 10, 2022 at the 2022
American Association for Cancer Research (AACR) Annual Meeting, the
Company presented preclinical data for its first generation of
androgen receptor (AR) ANITen bAsed Chimera (ANITAC™) (NTD)
degraders showing orally bioavailable ANITAC™ degraders can
eliminate full length, mutant and splice variant forms of AR that
are expressed in castration-resistant prostate cancer (CRPC)
patients, and that ANITAC degraders inhibit AR-dependent
transcription and reduce viability of AR-dependent prostate cancer
cells.
Summary Financial Results
- Net Loss. ESSA recorded a net loss of $10.9 million ($0.25 loss per common share based on 44,030,480
weighted average common shares outstanding) for the quarter ended
March 31, 2022, compared to a net
loss of $13.0 million ($0.36 loss per common share based on 36,484,041
weighted average common shares outstanding) for the quarter ended
March 31, 2021. For the quarter ended
March 31, 2022, this included
non-cash share-based payments of $1.9
million compared to $2.7
million for the comparable period in 2021, recognized for
stock options granted and vesting.
- Research and Development ("R&D") expenditures.
R&D expenditures for the quarter ended March 31, 2022 were $7.6
million compared to $7.3
million for the quarter ended March
31, 2021 and included non-cash costs related to share-based
payments ($1.1 million for the
quarter ended March 31, 2022 compared
to $791,969 for the quarter ended
March 31, 2021). The increase in
R&D expenditures for the first fiscal quarter ended
March 31, 2022 was primarily related
to clinical data analysis associated with the Phase 1a clinical
study, as well as increased expenses related to intellectual
property and salaries, as well as the non-cash share-based
expenses.
- General and administration ("G&A") expenditures.
G&A expenditures for the quarter ended March 31, 2022 were $3.8
million compared to $4.6
million for the quarter ended March
31, 2021 and included non-cash costs related to share-based
payments of $741,494 for the quarter
ended March 31, 2022 compared to
$1.9 million for the comparable
period in 2021. The increased expenditure is the result of
increased professional fees related to higher salaries and
benefits, as well as the non-cash share-based payments.
Liquidity and Outstanding Share Capital
At
March 31, 2022, the Company had
available cash reserves and short-term investments of $181.0 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
2024.
As of March 31, 2022, the Company
had 44,059,700 common shares issued and outstanding.
In addition, as of March 31, 2022
there were 3,234,750 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 314,750 warrants at a weighted
average exercise price of $49.69.
There were 6,795,736 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$5.33 per common share.
About EPI-7386
EPI-7386 is an investigational,
highly-selective, oral, small molecule inhibitor of the N-terminal
domain of the androgen receptor. EPI-7386 is currently being
studied in a Phase 1 clinical trial (NCT04421222) in men with mCRPC
whose tumors have progressed on current standard-of-care therapies.
The Phase 1 clinical trial of EPI-7386 began in calendar Q3 of 2020
following FDA allowance of ESSA's Investigational New
Drug application and Health Canada acceptance. EPI-7386 is also
being studied in earlier line mCRPC patients in Phase 1/2 trials in
combination with enzalutamide, apalutamide and abiraterone acetate
with prednisone. The U.S. FDA has granted Fast Track designation to
EPI-7386 for the treatment of adult male patients with mCRPC
resistant to standard-of-care treatment. ESSA retains all rights to
EPI-7386 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 under @ESSAPharma.
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, 2018).
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 can lead to mCRPC. The
treatment of mCRPC patients has evolved rapidly over the past ten
years. Despite these advances, many patients with mCRPC fail or
develop resistance to existing treatments, leading to continued
disease progression and limited survival rates.
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 Company's expectation to provide a clinical update on
the Phase 1a dose escalation study in the first half of 2022, the
expected commencement time of the Phase 1b study, the nature of the Phase 1/2 trial, the
potential clinical benefit of EPI-7386 in combination with approved
second-generation antiandrogens and the Company's expected cash
runway.
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 Quarterly Report on Form 10-Q dated May 10, 2022 under the heading "Risk Factors", a
copy of which is available on ESSA's profile on EDGAR at
www.sec.gov 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,
2022
|
|
September 30,
2021
|
|
|
|
|
Cash and cash
equivalents
|
$
86,236
|
|
$
137,825
|
Prepaids and other
assets
|
96,373
|
|
60,341
|
|
|
|
|
Total assets
|
$
182,609
|
|
$
198,166
|
|
|
|
|
Current
liabilities
|
3,749
|
|
3,930
|
Long-term
debt
|
145
|
|
210
|
Derivative
liability
|
-
|
|
20
|
Shareholders'
deficiency
|
178,715
|
|
194,006
|
|
|
|
|
Total liabilities and
shareholders' equity
|
$
182,609
|
|
$
198,166
|
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,
2022
|
|
Three months
ended
March 31,
2021
|
|
Six months
ended
March 31,
2022
|
|
Six months
ended
March 31,
2021
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research and development
|
$
7,649
|
|
$
7,268
|
|
$
13,669
|
|
$
11,754
|
Financing costs
|
4
|
|
-
|
|
8
|
|
1
|
General and administration
|
3,817
|
|
4,615
|
|
6,880
|
|
6,824
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
(11,470)
|
|
(11,883)
|
|
(20,557)
|
|
(18,579)
|
|
|
|
|
|
|
|
|
Gain (loss) on derivative
liability
|
118
|
|
(1,128)
|
|
18
|
|
(1,039)
|
Other items
|
498
|
|
47
|
|
586
|
|
90
|
|
|
|
|
|
|
|
|
Net loss before
taxes
|
(10,854)
|
|
(12,924)
|
|
(19,953)
|
|
(19,528)
|
Income tax
recovery
|
-
|
|
-
|
|
1
|
|
35
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss for the period
|
$
(10,854)
|
|
$
(12,964)
|
|
$
(19,952)
|
|
$
(19,493)
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(0.25)
|
|
$
(0.36)
|
$
(0.45)
|
|
$
(0.56)
|
|
|
|
|
|
|
|
|
Weighted average number
of
common shares
outstanding
|
44,030,480
|
|
36,484,041
|
|
44,009,903
|
|
34,896,509
|
|
|
|
|
|
|
|
|
|
|
|
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content:https://www.prnewswire.com/news-releases/essa-pharma-provides-corporate-update-and-reports-financial-results-for-fiscal-second-quarter-ended-march-31-2022-301543195.html
SOURCE ESSA Pharma Inc