ATLANTA, Jan. 27, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against ESSA Pharma Inc. (“ESSA” or the “Company”) (NASDAQ: EPIX). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information regarding the Company’s business, operations, and prospects, including allegations that: (i) masofaniten in combination with enzalutamide had no clear efficacy benefit over enzalutamide alone; (ii) accordingly, ...

Core Viewpoint - ESSA Pharma Inc. has decided to terminate its clinical development of masofaniten and is exploring strategic options to maximize shareholder value following disappointing trial results [2][3][4][6]. Company Updates - The decision to halt the clinical trials for masofaniten was based on an interim analysis indicating that the combination with enzalutamide was unlikely to meet its primary endpoint [2][3][4]. - ESSA is currently reviewing a range of strategic options, which may include mergers, asset sales, or other business combinations, and anticipates potential cost reductions [6]. Financial Results - For the fiscal year ended September 30, 2024, ESSA reported a net loss of $28.5 million, compared to a net loss of $26.6 million for the previous year [8]. - Research and Development (R&D) expenditures for the year were $21.2 million, slightly down from $21.3 million in the prior year, with fourth-quarter R&D expenditures at $4.2 million compared to $5.2 million in the same quarter of the previous year [8]. - General and Administration (G&A) expenditures increased to $13.2 million for the year ended September 30, 2024, up from $10.8 million in the previous year, with fourth-quarter G&A expenditures at $3.5 million compared to $1.9 million in the same quarter of the previous year [9]. Liquidity Position - As of September 30, 2024, ESSA had cash reserves and short-term investments totaling $126.8 million, with net working capital of $124.3 million and no long-term debt [10].

Core Insights - ESSA Pharma Inc. is progressing with its clinical studies on masofaniten, particularly in combination with enzalutamide for treating metastatic castration-resistant prostate cancer (mCRPC) [1][2][3] - The company plans to report updated data from its Phase 1 and Phase 2 studies in the second half of 2024 and mid-2025, respectively [1][3][5] - Financial results indicate a net loss of $7.2 million for the third quarter of fiscal 2024, with sufficient cash reserves to fund operations beyond 2025 [6][7] Clinical Development - The Phase 1 dose escalation study of masofaniten combined with enzalutamide is ongoing, with results expected to be presented at the ESMO 2024 congress [2][3] - Enrollment for the Phase 2 dose expansion study is projected to complete in Q1 2025, with preliminary data anticipated in mid-2025 [1][3] - The combination therapy has shown promising results, with 88% of patients achieving a PSA reduction of 50% or more [3] Financial Performance - For the third quarter ended June 30, 2024, ESSA reported a net loss of $7.2 million, slightly improved from a loss of $7.3 million in the same quarter of 2023 [6] - Research and Development (R&D) expenditures decreased to $5.5 million from $6.3 million year-over-year, reflecting a focus on ongoing clinical trials [6] - General and Administration (G&A) expenditures increased to $3.2 million from $2.6 million year-over-year, influenced by higher share-based payment costs [6] Liquidity Position - As of June 30, 2024, ESSA had cash reserves and short-term investments totaling $130.7 million, sufficient to support operations well into 2025 [7] - The company had 44,368,959 common shares outstanding as of the same date [7]

Core Viewpoint - ESSA Pharma Inc. is set to present at the JonesHealthcare Seaside Summit on July 15, 2024, focusing on innovations in prostate cancer treatment [1][3]. Company Overview - ESSA Pharma Inc. is a clinical-stage pharmaceutical company dedicated to developing novel therapies specifically for prostate cancer [4]. Event Details - The presentation will take place at 11:00 a.m. PT, and a live webcast will be available on the company's website, with an archive accessible for 90 days post-event [2]. - David R. Parkinson, the President and CEO of ESSA, will host the presentation and participate in a panel discussion titled "Innovations and Challenges in Prostate Cancer" at 9:00 a.m. PT [3].

Cash runway sufficient to fund operations beyond 2025 SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, May 14, 2024 - 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, 2024. "The year is off to a strong start with the presentation of updated Phase 1 masofaniten dose es ...

Financial Performance - As of March 31, 2024, ESSA Pharma Inc. reported cash and cash equivalents of $91,683,074, an increase from $33,701,912 as of September 30, 2023, representing a growth of approximately 172%[26] - For the three months ended March 31, 2024, the company incurred a net loss of $8,989,535, compared to a net loss of $7,060,239 for the same period in 2023, reflecting an increase in loss of approximately 27%[28] - The company reported a basic and diluted loss per common share of $0.20 for the three months ended March 31, 2024, compared to $0.16 for the same period in 2023, an increase of 25%[28] - Cash flows from operating activities for the six months ended March 31, 2024, were $(13,604,966), compared to $(10,387,656) for the same period in 2023, indicating a worsening cash flow situation[29] - Comprehensive loss for the six months ended March 31, 2024, was $14,934,482, compared to a loss of $13,831,809 for the same period in 2023, reflecting an increase of approximately 8%[215] - The company has never been profitable and expects to incur losses for the foreseeable future as it continues product development and seeks regulatory approvals[215] Research and Development - Research and development expenses for the six months ended March 31, 2024, were $11,554,751, up from $9,825,113 in the same period of 2023, indicating a rise of about 17.6%[28] - The Company reported research and development expenses of $3.2 million for the three months ended March 31, 2024, compared to $754,000 for the same period in 2023, indicating a significant increase[61] - Clinical costs related to the Phase 1 clinical trial of masofaniten (EPI-7386) amounted to $4,840,408 for the six months ended March 31, 2024, compared to $2,003,198 in 2023, representing a significant increase of approximately 142%[216] - The company is focused on developing small molecule drugs for the treatment of prostate cancer, with no products currently in commercial production or use as of March 31, 2024[33] - The company is focused on developing novel therapies for prostate cancer, specifically targeting the androgen receptor's N-terminal domain with its investigational compound masofaniten (EPI-7386)[81] Assets and Liabilities - Total assets decreased to $137,896,175 from $149,122,131, a decline of about 7.5%[26] - As of March 31, 2024, the accumulated deficit increased to $(194,415,216) from $(179,461,359) as of September 30, 2023, reflecting a rise of approximately 8.3%[26] - Total accounts payable and accrued liabilities increased to $4.1 million as of March 31, 2024, from $3.4 million as of September 30, 2023[48] - The balance of prepaid expenses rose to $1.2 million as of March 31, 2024, compared to $585,420 as of September 30, 2023[47] - Working capital as of March 31, 2024, was $133,123,568, down from $140,337,994 at the end of December 2023, indicating a decrease of about 5%[214] Investments and Financing - The company generated net cash provided by investing activities of $70,741,345 for the six months ended March 31, 2024, compared to $(2,371,351) in the same period of 2023, showing a significant improvement[29] - The Company filed a prospectus supplement to sell up to $50 million in Common Shares under an ATM Sales Agreement with Jefferies LLC[143] - The Company has recognized share-based payments expense totaling $1,922,124 for the six months ended March 31, 2024[65] Clinical Trials and Efficacy - The Company is advancing masofaniten (EPI-7386) through two clinical trials, including a combination trial with enzalutamide, to assess safety and drug-drug interactions[108] - The combination study of masofaniten with enzalutamide is ongoing, with initial results showing 88% of evaluable patients achieving PSA50 and 63% achieving PSA <0.2 ng/mL[132] - The Phase 1 clinical trial of masofaniten (EPI-7386) has completed enrollment for the monotherapy component and is actively enrolling for the combination component with abiraterone acetate and apalutamide[109] - The Phase 1/2 study evaluating masofaniten in combination with enzalutamide is currently enrolling patients, with updated dose escalation data presented at ESMO 2023[140] - The Company presented initial clinical data showing masofaniten's favorable safety profile and preliminary anti-tumor activity in heavily pretreated mCRPC patients[149] Regulatory Environment - The regulatory environment requires compliance with stringent safety, efficacy, and quality standards, which necessitates substantial time and financial resources for drug approval[187] - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug, with a single trial potentially sufficient in rare cases[199] - The cost of preparing and submitting a New Drug Application (NDA) exceeds $2,500,000, with significant annual user fees applicable[204] - The FDA conducts a preliminary review of an NDA within 60 days and aims for most applications to be reviewed within ten months from the date of filing[201] Intellectual Property - ESSA's competitive position is strengthened by its unique approach to prostate cancer treatment, targeting AR-NTD, which may bypass resistance pathways associated with current therapies[177] - The Company has a strong intellectual property position with 72 issued patents, including 20 U.S. patents, covering multiple structural classes of compounds[184]

Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in Phase 1 dose escalation in patients with mCRPC naïve to second generation antiandrogens, including 81% of patients achieving PSA90, 69% of patients achieving PSA90 in less than 90 days, and 63% of patients achieving PSA <0.2ng/mL Phase 2 dose expansion underway evaluating masofaniten plus enzalutamide in patients with mCRPC naïve to second generation antiandrogens; ESSA projecting completio ...

SOUTH SAN FRANCISCO, USA and VANCOUVER, CANADA, March 7, 2024  /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, is pleased to announce the results of the votes on matters considered at its Annual General Meeting of Shareholders held virtually on March 6, 2024 (the "Meeting"). At the Meeting, the shareholders of the Company (the "Shareholders") resolved to set the numbe ...

Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in Phase 1 dose escalation in patients with mCRPC, including 81% of patients achieving PSA90, 69% of patients achieving PSA90 in less than 90 days, and 63% of patients achieving PSA <0.2ng/mL Phase 2 masofaniten plus enzalutamide combination dose expansion study ongoing Cash runway sufficient to fund operations beyond 2025 SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Feb. 13, 2024 /P ...

FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37410 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Table of Contents (Exact name of registrant as specified in its charter) British Columbia, Canada 98-1250703 (State or ...