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ESSA Pharma (EPIX) - 2025 Q1 - Quarterly Report
2025-02-11 12:00
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]
Class Action Filed Against ESSA Pharma Inc. (EPIX) - March 25, 2025 Deadline to Join - Contact The Gross Law Firm
Prnewswire· 2025-02-06 10:45
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 ...
Shareholder Rights Law Firm Robbins LLP Urges EPIX Shareholders with Large Losses to Seek Counsel for the ESSA Pharma Inc. Class Action
Prnewswire· 2025-02-05 01:35
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 ...
March 25, 2025 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against EPIX
Prnewswire· 2025-02-03 10:45
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 ...
Levi & Korsinsky Announces the Filing of a Securities Class Action on Behalf of ESSA Pharma Inc.(EPIX) Shareholders
Prnewswire· 2025-01-31 10:45
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- ...
EPIX Investors Have Opportunity to Lead ESSA Pharma Inc. Securities Fraud Lawsuit
Prnewswire· 2025-01-29 04:15
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 ...
EPIX Investor Notice: Shareholder Rights Law Firm Robbins LLP Reminds Investors of the Class Action Against ESS Pharma Inc.
GlobeNewswire News Room· 2025-01-28 20:14
SAN DIEGO, Jan. 28, 2025 (GLOBE NEWSWIRE) -- 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 wi ...
EPIX Investors Have Opportunity to Lead ESSA Pharma Inc. Securities Fraud Lawsuit with the Schall Law Firm
Prnewswire· 2025-01-28 08:46
Core Viewpoint - A class action lawsuit has been filed against ESSA Pharma Inc. for alleged violations of securities laws, specifically related to misleading statements about the efficacy of its drug masofaniten in combination with enzalutamide [1][4]. Group 1: Lawsuit Details - The lawsuit is based on claims that ESSA made false and misleading statements regarding the effectiveness of masofaniten when used with enzalutamide for treating prostate cancer [4]. - The class period for the lawsuit is defined as December 12, 2023, to October 31, 2024, during which investors are encouraged to participate if they suffered losses [2]. Group 2: Investor Information - Investors who purchased ESSA's securities during the class period are urged to contact the Schall Law Firm before March 25, 2025, to discuss their rights [2][3]. - The class has not yet been certified, meaning that until certification occurs, affected investors are not represented by an attorney [3].
SHAREHOLDER ALERT: Class Action Lawsuit Filed on Behalf of ESSA Pharma Inc. (EPIX) Investors – Holzer & Holzer, LLC Encourages Investors With Significant Losses to Contact the Firm
GlobeNewswire News Room· 2025-01-27 16:12
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, ...
ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Fourth Quarter and Year Ended September 30, 2024
Prnewswire· 2024-12-17 12:00
Company has initiated a process to explore and review strategic options focused on maximizing shareholder value SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Dec. 17, 2024 /PRNewswire/ - ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company that, prior to the discontinuation of its clinical trials and preclinical and other development programs, has been focused on developing novel therapies for the treatment of prostate cancer, today provided a corporat ...