EPIX ESSA Pharma Inc.

7.11
+0.09  (+1%)
Previous Close 7.02
Open 7.05
52 Week Low 2.82
52 Week High 8.3089
Market Cap $206,250,513
Shares 30,028,511
Float 13,476,105
Enterprise Value $51,808,069
Volume 135,113
Av. Daily Volume 135,091
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Drug Pipeline

Drug Stage Notes
EPI-7386
Castrate resistant prostate cancer
Phase 1
Phase 1
Phase 1 initiation of dosing announced July 15, 2020.

Latest News

  1. HOUSTON and VANCOUVER, BC, Sept. 17, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX) (TSXV:EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of data of ESSA's clinical candidate, EPI-7386, at the ESMO Virtual Congress 2020. 

    The oral poster presentation titled, "Preclinical profile of EPI-7386, a second-generation N-terminal domain androgen receptor inhibitor for the treatment of prostate cancer" was published on Thursday, September 17th.

    The studies highlight new information about EPI-7386 including:

    • In vitro cellular gene expression analyses demonstrate that EPI-7386:
      • In an in vitro VCaP model, combination treatment of EPI-7386 with…

    HOUSTON and VANCOUVER, BC, Sept. 17, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX) (TSXV:EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of data of ESSA's clinical candidate, EPI-7386, at the ESMO Virtual Congress 2020. 

    The oral poster presentation titled, "Preclinical profile of EPI-7386, a second-generation N-terminal domain androgen receptor inhibitor for the treatment of prostate cancer" was published on Thursday, September 17th.

    The studies highlight new information about EPI-7386 including:

    • In vitro cellular gene expression analyses demonstrate that EPI-7386:
      • In an in vitro VCaP model, combination treatment of EPI-7386 with enzalutamide, apalutamide or darolutamide display broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone.
      • Shows superior activity to enzalutamide in an AR-V7-driven cellular model by modulating both AR-FL and AR-V7-driven gene expression with or without the addition of an external androgen such as R1881.

    "Previously, we presented in vitro data demonstrating that combination treatment of EPI-7386 with enzalutamide displays broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone. These newest transcriptomic analyses demonstrate a similar effect on inhibiting AR-regulated genes by combining EPI-7386 with apalutamide and darolutamide. These data provide additional rationale for studying the potential benefit of combining EPI-7386 with a variety of second-generation anti-androgens in earlier line prostate cancer patients," said Dr. David R. Parkinson, President & Chief Executive Officer.  

    About ESSA Pharma Inc.

    ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. ESSA's proprietary "aniten" compounds bind to the N-terminal domain of the androgen receptor ("AR"), inhibiting AR driven transcription and the AR signaling pathway in a unique manner which bypasses the drug resistance mechanisms associated with current anti-androgens. The Company is currently conducting a phase 1 study of EPI-7386 in patients with mCRPC who are failing current standard-of-care therapies. 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 generally represents a transition to the lethal variant of the disease, mCRPC, and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those who have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo animal studies, ESSA's novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

    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 that preclinical data support the development of EPI-7386 broadly in prostate cancer, the timing and enrollment of a Phase 1 study of EPI-7386,   future presentations with respect to EPI-7386 and the content thereof, and other 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 20-F dated December 19, 2019 under the heading "Risk Factors", a copy of which is available on ESSA's profile on the SEDAR website at www.sedar.com, ESSA's profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA's SEDAR profile. 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.

    Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Cision View original content:http://www.prnewswire.com/news-releases/essa-pharma-announces-the-presentation-of-additional-preclinical-data-for-epi-7386-at-the-esmo-virtual-congress-2020-301133275.html

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  2. HOUSTON and VANCOUVER, BC, Sept. 14, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX) (TSXV:EPI) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer today announced that the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer ("mCRPC") resistant to standard-of-care treatment.

    "We are pleased with the FDA's decision to grant Fast Track designation for development of EPI-7386 to treat mCRPC patients resistant to standard-of-care treatments," said…

    HOUSTON and VANCOUVER, BC, Sept. 14, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX) (TSXV:EPI) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer today announced that the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer ("mCRPC") resistant to standard-of-care treatment.

    "We are pleased with the FDA's decision to grant Fast Track designation for development of EPI-7386 to treat mCRPC patients resistant to standard-of-care treatments," said Dr. David R. Parkinson, Chief Executive Officer of ESSA Pharma. "This designation signifies recognition of the unmet medical need for new and effective treatments for this patient population. EPI-7386 may represent a promising novel treatment option for these patients and the designation offers the opportunity to interact more closely with the FDA during the development of EPI-7386."

    Fast Track is a designation granted by the FDA that is intended to facilitate development and expedite review of drugs to address an unmet medical need in the treatment of a serious life-threatening condition, and for which nonclinical or clinical data has demonstrated the potential of the drug to address this medical need.

    A drug that receives Fast track Designation is eligible for some, or all, of the following:

    • Eligibility for accelerated approval and priority review, if relevant criteria are met
    • Rolling review, enabling ESSA Pharma to submit completed sections of its New Drug Application ("NDA") for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed (NDA review usually does not begin until the Company has submitted the entire NDA to the FDA)
    • More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data to support drug approval
    • More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers

    About EPI-7386 Phase 1 Study

    The Phase 1 clinical trial (NCT04421222) expects to enroll approximately 18 mCRPC patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites. The study will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.

    About ESSA Pharma Inc.

    ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. The Company filed an IND with the U.S. Food and Drug Administration for EPI-7386 in the first calendar quarter of 2020 and clearance was received April 30,2020. A Clinical Trial Application was filed with Health Canada in April 2020 and authorization was received June 3rd, 2020. 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 generally represents a transition to the lethal variant of the disease, mCRPC, and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those who have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo animal studies, ESSA's novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

    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, the belief that EPI-7386 may represent a promising novel new treatment option, the potential benefits of the Fast Track designation including eligibility for accelerated approval and priority FDA review, planned enrollment of a Phase 1 study of EPI-7386,  and other 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 20-F dated December 19, 2019 under the heading "Risk Factors", a copy of which is available on ESSA's profile on the SEDAR website at www.sedar.com, ESSA's profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA's SEDAR profile. 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.

    Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Cision View original content:http://www.prnewswire.com/news-releases/essa-pharma-announces-fast-track-designation-granted-by-the-fda-to-epi-7386-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-301129748.html

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  3. HOUSTON and VANCOUVER, BC, Sept. 10, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX, TSXV:EPI, ))) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer announced the Company will be presenting at the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020 and at the Cantor Fitzgerald Global Healthcare Conference 2020 on Thursday September 17, 2020.

    Dr. David. R. Parkinson, Chief Executive Officer, will present a corporate overview of the Company's business and participate in a fireside chat at the respective conferences.  Dr. Parkinson along with ESSA's Chief Operating Officer, Peter Virsik, and Chief Financial Officer, David S.

    HOUSTON and VANCOUVER, BC, Sept. 10, 2020 /PRNewswire/ - ESSA Pharma Inc. (NASDAQ:EPIX, TSXV:EPI, ))) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer announced the Company will be presenting at the H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020 and at the Cantor Fitzgerald Global Healthcare Conference 2020 on Thursday September 17, 2020.

    Dr. David. R. Parkinson, Chief Executive Officer, will present a corporate overview of the Company's business and participate in a fireside chat at the respective conferences.  Dr. Parkinson along with ESSA's Chief Operating Officer, Peter Virsik, and Chief Financial Officer, David S. Wood will be available for one-on-one meetings.

    The presentations will be webcast live and can be accessed through the Investor Relations page at www.essapharma.com.  A replay of the presentations will be available on the Company's website for 90 days.

    H.C. Wainwright 22nd Annual Global Investment Conference 

    Presentation Date:        Wednesday September 16, 2020

    Presentation Time:       9:00am Pacific / 12:00pm Eastern

    Cantor Fitzgerald Global Healthcare Conference 2020:

    Fireside Chat Date:       Thursday September 17, 2020

    Fireside Chat Time:      11:40am Pacific / 2:40pm Eastern

    About ESSA Pharma Inc.

    ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. The Company filed an IND with the U.S. Food and Drug Administration for EPI-7386 in the first calendar quarter of 2020 and clearance was received April 30,2020. A Clinical Trial Application was filed with Health Canada in April 2020 and authorization was received June 3rd, 2020. 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 generally represents a transition to the lethal variant of the disease, mCRPC, and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those who have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo animal studies, ESSA's novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

    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, the belief that the Company is on a solid path to complete the Phase 1 dose escalation, expansion, and combination studies as planned,  timing and enrollment of a Phase 1 study of EPI-7386,  other statements surrounding the Company's clinical evaluation of EPI-7386, the funds from the recent financing supporting multiple combination studies with existing anti-androgen drugs, and the Company's current cash reserves.

    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 20-F dated December 19, 2019 under the heading "Risk Factors", a copy of which is available on ESSA's profile on the SEDAR website at www.sedar.com, ESSA's profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA's SEDAR profile. 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.

    Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Cision View original content:http://www.prnewswire.com/news-releases/essa-pharma-to-participate-in-multiple-upcoming-investor-conferences-301126962.html

    SOURCE ESSA Pharma Inc

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  4. VANCOUVER, BC and HOUSTON, Aug. 6, 2020 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ:EPIX) (TSXV:EPI), 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 third quarter ended June 30, 2020. All references to "$" in this release refer to United States dollars, unless otherwise indicated.

    "This past quarter has seen ESSA receive acceptance from the FDA and Health Canada to commence the clinical trial of EPI-7386, leading to the significant milestone of dosing the first patient in July,"  stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "With the funds…

    VANCOUVER, BC and HOUSTON, Aug. 6, 2020 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ:EPIX) (TSXV:EPI), 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 third quarter ended June 30, 2020. All references to "$" in this release refer to United States dollars, unless otherwise indicated.

    "This past quarter has seen ESSA receive acceptance from the FDA and Health Canada to commence the clinical trial of EPI-7386, leading to the significant milestone of dosing the first patient in July,"  stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "With the funds we have received from the recent financing, we believe we are in a very strong position to complete the Phase 1 dose escalation, expansion, and combination studies as planned."

    Recent Corporate Highlights

    • On July 31st, the Company closed a public offering of common shares, led by Jefferies, as sole book-running manager, for gross proceeds of US$48,990,000. Certain existing investors participated in the financing along with new investors: Pfizer Inc. (NYSE:PFE), Avidity Partners, CAM Capital, Point72, Ridgeback Capital, Sphera Healthcare,Vivo Capital, and others.



    • On July 15th, the Company announced that the first patient had been dosed in a Phase 1 clinical trial designed to evaluate the safety and tolerability of EPI-7386 in mCRPC patients who failed standard of care treatments, including second generation anti-androgens. The trial, to be conducted at five sites in the United States and Canada, is expected to enroll approximately 18 patients in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort. Funds from the recent financing will support multiple combination studies with existing anti-androgen drugs.



    • On June 22nd , the Company presented new preclinical data on ESSA's clinical candidate, EPI-7386, at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II. In an oral poster presentation titled, "Pre-clinical development of the second-generation N-terminal domain androgen receptor inhibitor, EPI-7386, for the treatment of prostate cancer", results from preclinical studies of EPI-7386 including studies evaluating androgen receptor binding, gene expression analyses and the toxicologic profile were presented.

    Summary Financial Results

    • Net Income (Loss). ESSA recorded a net loss of $4.9 million ($0.24 loss per common share based on 20,824,568 weighted average common shares outstanding) for the quarter ended June 30, 2020, compared to a net loss of $3.3 million ($0.52 loss per common share based on 6,383,737 weighted average common shares outstanding) for the quarter ended June 30, 2019. This included non-cash share-based payments of $1.5M for the quarter ended June 30, 2020 compared to $255,365 for the quarter ended June 30, 2019, recognized for stock options granted and vesting.



    • Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended June 30, 2020 were $2.7 million compared to $1.95 million for the quarter ended June 30, 2019. The increase in R&D expenditures for the quarter were primarily related to preparing the IND application for EPI-7386, preparatory clinical costs, manufacturing and chemistry costs, and non-cash costs related to share-based payments ($382,941 for quarter ending June 30, 2020 compared to $72,306 for quarter ended June 30, 2019). R&D costs in the comparative period were primarily related to preclinical research of the Company's next-generation aniten compounds.



    • General and administration ("G&A") expenditures. G&A expenditures for the quarter ended June 30, 2020 were $2.2 million compared to $1.2 million for the quarter ended June 30, 2019. The increase in the quarter is primarily due to non-cash share-based payments. ($1.1M for quarter ending June 30, 2020 compared to $183,059 for the quarter ending June 30, 2019.)

    Liquidity and Outstanding Share Capital

    Cash on hand at June 30, 2020 was $36.5 million, with working capital of $36.5 million, reflecting the aggregate gross proceeds of the August 2019 financing of $36 million and the acquisition of Realm Therapeutics plc which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

    As of June 30, 2020, the Company had 20,841,261 common shares issued and outstanding.

    In addition, as of June 30, 2020, there were 12,331,127 common shares issuable upon the exercise of warrants and broker warrants. This includes 11,919,404 prefunded warrants at an exercise price of $0.0001 that were issued in lieu of common shares in the August 2019 financing, and 411,723 other warrants at a weighted average exercise price of $38.93. There are 5,309,584 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.42 per common share.

    About ESSA Pharma Inc.

    ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. The Company filed an IND with the U.S. Food and Drug Administration for EPI-7386 in the first calendar quarter of 2020 and clearance was received April 30,2020. A Clinical Trial Application was filed with Health Canada in April 2020 and authorization was received June 3rd, 2020.

    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 generally represents a transition to the lethal variant of the disease, mCRPC, and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those who have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo animal studies, ESSA's novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

    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, the belief that the Company is on a solid path to complete the Phase 1 dose escalation, expansion, and combination studies as planned,  timing and enrollment of a Phase 1 study of EPI-7386,  other statements surrounding the Company's clinical evaluation of EPI-7386, the funds from the recent financing supporting multiple combination studies with existing anti-androgen drugs, and the Company's current cash reserves .

    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 20-F dated December 19, 2019 under the heading "Risk Factors", a copy of which is available on ESSA's profile on the SEDAR website at www.sedar.com, ESSA's profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA's SEDAR profile. 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.

    Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    ESSA PHARMA INC.

    CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

    (Unaudited)

    Amounts in thousands of United States dollars





    June 30, 2020



    September 30, 2019











    Cash

    $

    36,482



    $

    53,323

    Prepaid and other assets



    1,805



    1,451











    Total assets

    $

    38,287



    $

    54,774











    Current liabilities



    1,268



    5,575

    Derivative liability 



    84



    18

    Shareholders' deficiency



    36,936



    49,181











    Total liabilities and shareholders' deficiency

    $

    38,287



    $

    54,774

    ESSA PHARMA INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)

    Amounts in thousands of United States dollars, except share and per share data











    Three months ended

    June 30, 2020



    Three months ended

    June 30, 2019









    OPERATING EXPENSES







        Research and development

    $

    2,704



    $

    1,951

        Financing costs

    197



    139

        General and administration

    2,176



    1,213









    Total operating expenses

    (5,077)



    (3,303)









        Gain (loss) on derivative liability

    (40)



    15

        Other items

    (184)



    3









    Net loss before taxes

    (4,933)



    (3,285)

    Income tax expense





    (16)









    Net loss for the period

    $

    (4,933)



    $

    (3,301)









    Basic and diluted loss per common share

    $

    (0.24)



    $

    (0.52)









    Weighted average number of

    common shares outstanding

    20,824,568



     

    6,383,737

     

    Cision View original content:http://www.prnewswire.com/news-releases/essa-pharma-provides-corporate-update-and-reports-financial-results-for-fiscal-third-quarter-ended-june-30-2020-301108123.html

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  5. HOUSTON and VANCOUVER, BC, July 31, 2020 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ:EPIX) (TSXV:EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the closing of an underwritten public offering of 7,100,000 common shares of the Company at a public offering price of US$6.00 per share, before underwriting discounts, for an aggregate offering of approximately US$42.6 million (the "Offering"). ESSA granted the underwriters a 30-day option to purchase up to an additional 1,065,000 common shares (the "Option"), and the underwriters exercised the Option on July 29, 2020. The proceeds to ESSA from the Offering, including the exercise of the…

    HOUSTON and VANCOUVER, BC, July 31, 2020 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ:EPIX) (TSXV:EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the closing of an underwritten public offering of 7,100,000 common shares of the Company at a public offering price of US$6.00 per share, before underwriting discounts, for an aggregate offering of approximately US$42.6 million (the "Offering"). ESSA granted the underwriters a 30-day option to purchase up to an additional 1,065,000 common shares (the "Option"), and the underwriters exercised the Option on July 29, 2020. The proceeds to ESSA from the Offering, including the exercise of the Option, were approximately US$45.0 million after deducting underwriting discounts and commissions (such commission being equal to 6% of the aggregate gross proceeds of the Offering) and other estimated offering expenses. Existing investors participated in the financing along with new investors Pfizer Inc. (NYSE:PFE), Avidity Partners, CAM Capital, Point72, Ridgeback Capital, Sphera Healthcare and Vivo Capital.

    ESSA intends to use the net proceeds of the Offering for pre-clinical and clinical activities, chemistry, manufacturing and controls, research and development, as well as working capital and general corporate purposes.  Such proceeds will primarily be used to expand the ongoing Phase 1 dose-escalation and extension studies and allow the potential for conducting multiple combination studies with EPI-7386.  The proceeds are also expected to cover initial expenses of the following Phase 2 trial and allow further investment in the Company's pipeline programs.  Based on current Company estimates, the net proceeds from the Offering combined with the Company's current cash reserves are expected to provide sufficient cash resources through 2023.

    Jefferies acted as sole book-running manager for the Offering. Oppenheimer & Co. acted as lead manager for the Offering and Bloom Burton Securities Inc. acted as co-manager for the Offering.

    The securities described above were offered by ESSA in the United States pursuant to a shelf registration statement on Form F-3 (File No. 333-225969) that was previously filed by ESSA with the Securities and Exchange Commission (the "SEC") and became effective on July 17, 2018 and in Canada pursuant to ESSA's Canadian short form base shelf prospectus (the "Canadian Base Shelf Prospectus") dated July 12, 2018 that was previously filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario.

    A preliminary prospectus supplement related to the Offering was filed with the SEC on July 28, 2020, and a final prospectus supplement related to the Offering was filed with the SEC on July 29, 2020, and each are available on the SEC's website at http://www.sec.gov. A preliminary prospectus supplement to ESSA's Canadian Base Shelf Prospectus was also filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario on July 28, 2020 and is available at http://www.sedar.com and a final prospectus related to the Offering was filed with the securities regulatory authorities in each of the provinces of British Columbia, Alberta and Ontario on July 29, 2020 and is available at http://www.sedar.com.  

    About ESSA Pharma Inc.

    ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. The Company filed an IND with the U.S. Food and Drug Administration for EPI-7386 in the first calendar quarter of 2020 and clearance was received April 30,2020. A Clinical Trial Application was filed with Health Canada in April 2020 and authorization was received June 3rd, 2020.

    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 generally represents a transition to the lethal variant of the disease, mCRPC, and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those who have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo animal studies, ESSA's novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.

    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, the timing and enrollment of a Phase 1 study of EPI-7386,  future presentations with respect to EPI-7386 and the content thereof, other statements surrounding the Company's clinical evaluation of EPI-7386, the Company's current cash reserves and the anticipated use of proceeds from the Offering.

    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 20-F dated December 19, 2019 under the heading "Risk Factors", a copy of which is available on ESSA's profile on the SEDAR website at www.sedar.com, ESSA's profile on EDGAR at www.sec.gov, and as otherwise disclosed from time to time on ESSA's SEDAR profile. 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.

    Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Cision View original content:http://www.prnewswire.com/news-releases/essa-pharma-completes-public-offering-for-aggregate-gross-proceeds-of-us48-990-000--301103940.html

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