Lawsuit filed for Investors who lost money with shares of ESSA Pharma Inc. (NASDAQ: EPIX)

An investor, who purchased shares of ESSA Pharma Inc. (NASDAQ: EPIX), filed a lawsuit over alleged violations of Federal Securities Laws by ESSA Pharma Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of ESSA Pharma Inc. (NASDAQ: EPIX) have certain options and for certain investors are short and strict deadlines running. Deadline: March 25, 2025. NASDAQ: EPIX investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Canada based ESSA Pharma Inc., a clinical stage pharmaceutical company, focuses the development of small molecule drugs for the treatment of prostate cancer. At all relevant times the Company's lead product candidate was masofaniten (EPI-7386), an investigational, oral, small molecule inhibitor of the androgen receptor, which plays a pivotal role in the development and progression of prostate cancer, especially castration-resistant prostate cancer ("CRPC").

ESSA Pharma Inc. was evaluating masofaniten in various clinical trials as a monotherapy and combination therapy for the treatment of prostate cancer. These trials included, among others, EPI-7386-CS-010 (the "M-E Combination Study"), a Phase 1/2 study of masofaniten in combination with enzalutamide compared with enzalutamide alone in patients with metastatic CRPC.
Phase 1 of the M-E Combination Study was a single-arm dose escalation study of masofaniten in combination with a fixed dose of enzalutamide. Based on results from the Phase 1 portion of the M-E Combination Study, ESSA purportedly identified a recommended Phase 2 combination dose of masofaniten 600 mg twice daily combined with enzalutamide 160 mg once daily ("QD"). Phase 2 of the M-E Combination Study compared this recommended combination dose with a 160 mg QD enzalutamide monotherapy-the standard of care for the intended patient population. The primary endpoint of Phase 2 of the M-E Combination Study was the proportion of patients reaching "PSA90," which refers to deep prostate-specific antigen ("PSA") response with a greater than or equal to 90% decline in PSA. PSA90 is an important indicator of a patient's response to prostate cancer treatment.
Because masofaniten was ESSA's lead and most advanced product candidate, establishing its clinical, regulatory, and commercial viability was of central importance to Defendants and investors alike. Indeed, according to ESSA's website, apart from masofaniten, the Company only has two other product candidates, each of which is still in early development at either the research or preclinical stage

ESSA Pharma Inc. reported that its Total Revenue rose from over $32.13 billion for the 12 months period that ended on September 30, 2023, to over $34.42 billion for the 12 months period that ended on September 30, 2024, and that its Net Loss over those respective time periods increased from over $26.45 billion to $28.54 billion.

On October 31, 2024, during after-market hours, ESSA Pharma Inc announced its decision to terminate Phase 2 of the M-E Combination Study, citing "a protocol-specified interim review of the safety, PK [pharmacokinetics] and efficacy data, which showed a much higher rate of PSA90 response in patients treated with enzalutamide monotherapy . . . than were expected based upon historical data" and "no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent." The Company further advised that "a futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study" and that, "[a]s part of the effort to focus its resources," it was "planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination with other agents."

Shares of ESSA Pharma Inc. (NASDAQ: EPIX) declined from $10.25 per share on February 15, 2024, to $1.40 per share on November 01, 2024.

The plaintiff claims that between December 12, 2023 and October 31, 2024, the Defendants made false and/or misleading statements and/or failed to disclose that masofaniten in combination with enzalutamide had no clear efficacy benefit over enzalutamide alone, that accordingly, masofaniten in combination with enzalutamide was less effective in treating prostate cancer than Defendants had led investors to believe, that the M-E Combination Study was unlikely to meet its prespecified Phase 2 primary endpoint, that accordingly, Defendants had overstated masofaniten's clinical, regulatory, and commercial prospects, and that as a result, Defendants' public statements were materially false and misleading at all relevant times.

Those who purchased shares of ESSA Pharma Inc. (NASDAQ: EPIX) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.