Core Viewpoint - A class action securities lawsuit has been filed against ESSA Pharma Inc. due to alleged securities fraud affecting investors between December 12, 2023, and October 31, 2024 [1][2] Group 1: Allegations and Claims - The lawsuit claims that the defendants made false statements regarding the efficacy of masofaniten in combination with enzalutamide, suggesting it had no clear benefit over enzalutamide alone [2] - It is alleged that masofaniten was less effective in treating prostate cancer than previously communicated to investors [2] - The M-E Combination Study was reportedly unlikely to meet its prespecified Phase 2 primary endpoint, contradicting the defendants' claims [2] - Defendants are accused of overstating masofaniten's clinical, regulatory, and commercial prospects, leading to materially false and misleading public statements [2] Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until March 25, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees, with no obligation to participate [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4]

Core Viewpoint - A class action has been filed against ESSA Pharma Inc. for allegedly misleading investors about the efficacy of its drug candidate masofaniten, particularly in its combination with enzalutamide for treating prostate cancer [1][2]. Group 1: Allegations and Findings - The complaint alleges that ESSA failed to disclose that masofaniten combined with enzalutamide showed no clear efficacy benefit over enzalutamide alone [2]. - It is claimed that the M-E Combination Study was unlikely to meet its prespecified Phase 2 primary endpoint, indicating that the company overstated masofaniten's clinical and commercial prospects [2]. - On October 31, 2024, ESSA announced the termination of Phase 2 of the M-E Combination Study, citing a higher rate of PSA90 response in patients treated with enzalutamide alone and no clear efficacy benefit from the combination [3]. Group 2: Market Impact - Following the announcement of the study termination, ESSA's stock price fell by $3.80 per share, a decrease of 73.08%, closing at $1.40 per share on November 1, 2024 [3]. Group 3: Class Action Participation - Investors may be eligible to participate in the class action against ESSA Pharma Inc., with options to serve as lead plaintiff or remain an absent class member [4]. - Robbins LLP operates on a contingency fee basis, meaning shareholders incur no fees or expenses for participation [5].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of ESSA Pharma Inc. regarding a class action lawsuit due to alleged misleading statements related to the efficacy of masofaniten in combination with enzalutamide for prostate cancer treatment [1][2]. Group 1: Allegations and Class Period - The class period for the allegations is from December 12, 2023, to October 31, 2024 [2]. - Allegations include that the defendants made materially false and misleading statements about masofaniten's efficacy and overstated its clinical and commercial prospects [2]. Group 2: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by March 25, 2025, to potentially become lead plaintiffs [3]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the case [3]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights and seeks recovery for those who suffered losses due to deceitful practices by companies [4].

Financial Performance - ESSA reported a net loss of $8.5 million for Q1 2025, compared to a net loss of $6.0 million for Q1 2024, representing an increase of approximately 42%[3] - The total operating expenses for Q1 2025 were $9.7 million, compared to $7.6 million for Q1 2024, indicating a year-over-year increase of approximately 28%[12] - The company reported a basic and diluted loss per common share of $0.19 for Q1 2025, compared to $0.14 for Q1 2024[12] Research and Development - Research and Development (R&D) expenditures for Q1 2025 were $5.5 million, slightly up from $5.4 million in Q1 2024, with non-cash share-based payments increasing to $729,780 from $526,241[3] General and Administrative Expenses - General and Administration (G&A) expenditures rose significantly to $4.2 million in Q1 2025 from $2.2 million in Q1 2024, with non-cash share-based payments increasing to $1,972,151 from $277,177[3] Cash and Assets - As of December 31, 2024, ESSA had cash reserves and short-term investments of $120.6 million and net working capital of $118.8 million, with no long-term debt[9] - ESSA's total assets decreased to $122.6 million as of December 31, 2024, down from $128.1 million as of September 30, 2024[11] Strategic Options - The company is exploring strategic options including potential mergers, asset sales, or other business combinations to maximize shareholder value following the termination of clinical trials for masofaniten[2] - The company anticipates headcount and other cost reductions as part of its strategic review process[2] Shareholder Information - The weighted average number of common shares outstanding increased to 44,388,550 in Q1 2025 from 44,129,491 in Q1 2024[12]

Financial Performance - Net loss for the period increased to $8,531,931 for the three months ended December 31, 2024, compared to a net loss of $5,964,322 for the same period in 2023, reflecting a rise of approximately 42%[27] - Comprehensive loss for the three months ended December 31, 2024, was $8,531,931, compared to a loss of $5,964,322 for the same period in 2023, reflecting an increase of approximately 43%[213] - The company has never been profitable and expects to incur losses for the foreseeable future as it winds down clinical and preclinical development programs[213] Assets and Liabilities - Total assets decreased from $128,112,003 as of September 30, 2024, to $122,634,340 as of December 31, 2024, representing a decline of approximately 4.1%[26] - Total liabilities increased to $3,867,336 as of December 31, 2024, from $3,506,233 as of September 30, 2024, an increase of about 10.3%[26] - Cash and cash equivalents decreased from $103,709,537 at the beginning of the period to $93,310,889 by the end of the period, a reduction of about 10.5%[29] Expenses - Research and development expenses were $5,474,147 for the three months ended December 31, 2024, slightly up from $5,376,764 in the prior year, indicating a year-over-year increase of about 1.8%[27] - General and administration expenses surged to $4,210,719 in Q1 2024, compared to $2,217,868 in Q1 2023, marking an increase of approximately 89.9%[27] - Clinical costs increased to $3,248,718 in Q4 2024 from $1,827,247 in Q4 2023, marking an increase of approximately 78% due to expanded clinical trial activities[214] - Share-based payments increased significantly to $2,701,931 in Q1 2024 from $803,418 in Q1 2023, reflecting a rise of approximately 236%[30] - Share-based payments in general and administrative expenses increased to $1,972,151 in Q4 2024 from $277,177 in Q4 2023, reflecting a substantial rise in non-cash expenses[222] Clinical Trials and Research - The company has terminated its clinical trial of masofaniten, its primary molecule, and is currently evaluating its future operations[34] - The Company terminated its clinical trials for masofaniten (EPI-7386) based on interim review data showing a higher PSA90 response rate in patients treated with enzalutamide monotherapy compared to the combination therapy[82] - The decision to discontinue clinical trials was mutually agreed upon by senior management and the board of directors, indicating a strategic shift in focus[82] - The Company has decided to withdraw its Investigational New Drug application and related clinical trial applications for masofaniten[84] - The company has suspended enrollment in a clinical trial with Janssen due to operational recruitment challenges[128] - The company has terminated its preclinical development programs while exploring other potential clinical applications for NTD inhibitors[134] Strategic Review and Future Plans - The Company is undergoing a comprehensive review of strategic options to maximize shareholder value, which may include mergers, acquisitions, or other strategic transactions[79] - The company is reviewing strategic options, which may include mergers, asset sales, or seeking new product candidates for development[136] - The company is not currently engaged in any collaborations for clinical development and future plans depend on ongoing strategic evaluation[168] Market and Competitive Position - The prostate cancer market is significant, with an estimated 299,010 new cases in 2024 and 35,250 deaths expected[92] - Approximately 260,000 men with prostate cancer were treated in the U.S. in 2023 with systemic treatments who had not yet received a second-generation antiandrogen[92] - ESSA's competitive position is believed to be strong due to its unique approach to prostate cancer treatment targeting AR activation[167] Intellectual Property and Regulatory Compliance - ESSA has in-licensed intellectual property related to compounds that modulate AR activity, providing exclusive rights to develop and commercialize products based on this IP[175] - The company is required to pay up to C$2.4 million for the first drug product developed under the license and C$510,000 for each subsequent product[177] - The patent protection for masofaniten (EPI-7386) is expected to last until expiration dates ranging from 2036 to 2043[183] - Regulatory compliance is essential for the production and manufacture of future product candidates, subject to various governmental regulations[185] Shareholder and Financial Obligations - The Company has a maximum of 10,810,907 common shares reserved for issuance under the Omnibus Incentive Plan as of December 31, 2024[57] - The Company has $139,204 due to related parties, an increase from $98,360 as of September 30, 2024[68] - The company has not incurred any immediate financial obligations related to the termination of the clinical trial, indicating a potential for cost savings in the short term[34]

NEW YORK, Feb. 6, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of ESSA Pharma Inc. (NASDAQ: EPIX).Shareholders who purchased shares of EPIX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/essa-pharma-inc-loss-submission-form/?id=127279&from=4CLASS PERIOD: December 12, 2023 to ...

SAN DIEGO, Feb. 4, 2025 /PRNewswire/ -- Robbins LLP reminds investors that a class action was filed on behalf of all persons and entities that purchased or otherwise acquired ESSA Pharma Inc. (NASDAQ: EPIX) securities between December 12, 2023 and October 31, 2024. ESSA is a clinical stage pharmaceutical company that focuses on the development of small molecule drugs for the treatment of prostate cancer. The Company's lead product candidate was masofaniten, which was in clinical trial in combination with en ...

NEW YORK, Feb. 3, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of ESSA Pharma Inc. (NASDAQ: EPIX).Shareholders who purchased shares of EPIX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/essa-pharma-inc-loss-submission-form/?id=126284&from=4 CLASS PERIOD: December 12, 2023 to ...

NEW YORK, Jan. 31, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in ESSA Pharma Inc. ("ESSA Pharma Inc." or the "Company") (NASDAQ: EPIX) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of ESSA Pharma Inc. investors who were adversely affected by alleged securities fraud between December 12, 2023 and October 31, 2024. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/essa-pharma- ...

NEW YORK, Jan. 28, 2025 /PRNewswire/ --Why: Rosen Law Firm, a global investor rights law firm, announces that a shareholder filed a class action on behalf of purchasers and acquirers of securities of ESSA Pharma Inc. (NASDAQ: EPIX) between December 12, 2023 and October 31, 2024, inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than March 25, 2025.So what: If you purchased ESSA Pharma Inc. securities during ...