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ESSA Pharma Announces Clinical Collaboration with Astellasto Evaluate the Combination of EPI-7386 and Enzalutamide forPatients with Metastatic Castration-Resistant Prostate Cancer

Thursday, February 25, 2021

ESSA Pharma Inc., a  clinical-stage  pharmaceutical  company  focused  on developing  novel  therapies  for  the  treatment  of  prostate  cancer,  todayannounced that the Company has entered  into a  clinical collaboration and  supply agreementwith AstellasPharma Inc.(“Astellas”) to evaluate ESSA’slead product candidate, EPI-7386, a first-in-class N-terminal domain  androgen  receptor  inhibitor,  in  combination with Astellasand  Pfizer  Inc.’sandrogen receptor inhibitor, enzalutamide, inpatients with metastatic castration-resistant prostate cancer(“mCRPC”).

Under the terms of the agreement, ESSA will sponsor and conduct aPhase 1/2 study toevaluatethe safety, tolerability and preliminary efficacy of the combination of EPI-7386 and enzalutamideinmCRPCpatientswho  have  not  yet  been  treated  with  second-generation  antiandrogen therapies. Astellas will supply enzalutamide for the trial. ESSA will retain all rights to EPI-7386.The clinical study is expected to start in 2021.

“We are delighted to collaboratewith Astellasto explore the potential clinical role of EPI-7386 in combination with Astellas’enzalutamide in patients with metastatic castration-resistant prostate cancer,who have  progressed  on  androgen  deprivation  therapy,” said Dr.  David.  R.  Parkinson, Chief  Executive  Officer,ESSA  Pharma  Inc. “Combining  our  two  therapies  will  simultaneously target both ends of the androgen receptor. In preclinical models, we have seen that combining EPI-7386  with  current  antiandrogens  can  lead  to  deeper  and  broader  inhibition  of  androgen biology.We look forward to investigating the combination of these therapies and their potential role together inthe treatment of prostate cancer.”

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 studiedin a Phase1 clinical trial(NCT04421222) in men with mCRPC”)whose tumors have progressed oncurrentstandard-of-caretherapies. The Phase I clinical trial of EPI-7386 began in Q3 of 2020 following FDA allowance of theINDand Health Canada acceptance. 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 withprostate  cancer. For  more  information,  please  visit www.essapharma.comand 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 tenyears. 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 DisclaimerThis  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 potential results of the collaborationwith Astellas,the anticipated start date in 2021 of the clinical studies andother statements surrounding the Company’s clinical evaluation of EPI-7386.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-Kdated December 15, 2020under the heading“Risk Factors”, a copy of which is available on ESSA’s profile on  EDGAR at www.sec.gov,  and  as  otherwise  disclosed  from  time  to  time  on  ESSA’s  SEDAR  profilewww.sedar.com.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  Canadian  and  United States  securities  laws.  Readers  are  cautioned  against  attributing  undue  certainty  to  forward-looking statements.Company Contact:Peter Virsik, Chief Operating Officer ESSA Pharma Inc. Contact: (778) 331-0962Investor Relations Contact:Alan Lada, Vice PresidentSolebury TroutContact: (617) 221-8006

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