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ESSA Pharma Inc. (EPIX0.00%) has submitted its Form 10-K filing for the fiscal year ended September 30, 2024.
The company announced the termination of its Phase 2 clinical trial evaluating masofaniten (EPI-7386) in combination with enzalutamide versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC) naĂŻve to second-generation antiandrogens. This decision was based on a protocol-specified interim review showing a higher rate of PSA90 response in patients treated with enzalutamide monotherapy than expected.
ESSA has also decided to terminate all remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten (EPI-7386), either as a monotherapy or in combination with other agents. The company will withdraw its Investigational New Drug (IND) application and Clinical Trial Applications (CTAs).
ESSA has initiated a comprehensive review process to explore strategic options to maximize shareholder value. These options may include a merger, amalgamation, arrangement, reverse take-over, business combination, asset sale or acquisition, shareholder distribution, wind-down, liquidation and dissolution, or other strategic transactions.
The company reported a net loss of $28,542,821 for the fiscal year ended September 30, 2024, compared to a net loss of $26,582,343 for the previous fiscal year. Research and development expenses for the year totaled $21,206,824, with significant costs attributed to clinical trials and preclinical studies.
As of September 30, 2024, ESSA had cash and cash equivalents of $103,709,537 and short-term investments of $23,050,582. The company believes it has sufficient capital to fund its operations through 2025, including the wind down of its clinical trials and preclinical development programs.
ESSA's future plans include a focus on evaluating strategic alternatives, which may involve significant costs and resources. There is no assurance that any particular strategic transaction will be consummated or that it will enhance shareholder value.
The company continues to face risks related to its financial position, including the need for additional capital, potential litigation, and the impact of regulatory changes. ESSA has not declared any dividends and does not anticipate doing so in the foreseeable future.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the ESSA Pharma Inc. annual 10-K report dated December 17, 2024. To report an error, please email earnings@qz.com.