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ESSA Pharma Inc. (NASDAQ: EPIX) is a clinical-stage pharmaceutical company dedicated to advancing novel therapeutics for cancer patients, specifically those battling castration-resistant prostate cancer (CRPC). Founded on cutting-edge research, ESSA Pharma is pioneering the development of small molecule drugs that selectively target the amino-terminal domain of the androgen receptor. This innovative approach aims to overcome known AR-dependent resistance mechanisms in CRPC, potentially offering improved progression-free and overall survival for patients.
ESSA Pharma's flagship candidate, Masofaniten (formerly EPI-7386), is a first-in-class N-terminal domain androgen receptor (AR) inhibitor. Additionally, the company has demonstrated promising results in Phase 1/2 clinical trials that combine Masofaniten with Enzalutamide, another AR inhibitor. These trials have shown deep, durable reductions in prostate-specific antigen (PSA) levels, which are crucial markers in prostate cancer treatment.
Recent data presented at the European Society of Medical Oncology (ESMO) 2023 Congress and the Prostate Cancer Foundation Scientific Retreat reveal that the combination therapy of Masofaniten and Enzalutamide is well-tolerated and effective in reducing PSA levels in patients with metastatic CRPC. The randomized Phase 2 dose expansion study is currently enrolling, with the goal of further elucidating the clinical benefits of this combination therapy.
In recent developments, ESSA Pharma has entered into an ATM Sales Agreement with Jefferies LLC to raise up to US$50 million in capital, ensuring a strong financial runway for ongoing and future projects. The company also reported encouraging financial results for the fiscal year ended September 30, 2023, and the fiscal first quarter of 2024, reflecting a robust cash position expected to fund operations through 2025.
ESSA Pharma's strategy includes exploring additional combinations of Masofaniten with other standard-of-care antiandrogens. The U.S. Food and Drug Administration has granted Fast Track designation to Masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatments, underscoring the potential importance of this therapy.
For more information, visit the company’s website at www.essapharma.com, or follow them on Twitter and LinkedIn.
ESSA Pharma Inc. (NASDAQ: EPIX) reported a comprehensive loss of $6.7 million for the first quarter ended December 31, 2022, an improvement from $9.1 million in the same period of 2021. The company continues to advance its clinical studies of EPI-7386, a novel treatment for metastatic castration-resistant prostate cancer (mCRPC), with completion of the Phase 1 combination study with enzalutamide expected in 1H2023, followed by a Phase 2 study. As of December 31, 2022, ESSA maintained a solid cash position of $163.1 million, sufficient to fund operations through 2025.
ESSA Pharma Inc. (NASDAQ: EPIX) announced its participation in a fireside chat at the Guggenheim Healthcare Talks 5th Annual Oncology Conference on February 9, 2023, at 9:00 a.m. Eastern Time in New York City. Key executives, including President and CEO David R. Parkinson, will also hold one-on-one meetings. A live webcast of the presentation will be available on ESSA's website, with an archived replay accessible for 30 days after the event. ESSA focuses on developing novel therapies for prostate cancer, aiming to provide innovative treatment solutions for patients.
ESSA Pharma Inc. (EPIX) reported key corporate updates and financial results for the fiscal year ending September 30, 2022. The company achieved significant milestones with its lead candidate EPI-7386, showing initial anti-tumor activity in clinical trials for metastatic castration-resistant prostate cancer (mCRPC). ESSA recorded a net loss of $35.1 million, compared to $36.8 million in 2021, while R&D expenses remained consistent at $24.4 million. As of September 30, 2022, the company had a strong cash position of $167.2 million, expected to fund operations through 2025.
ESSA Pharma (NASDAQ: EPIX) announced its participation in two investor conferences, aimed at discussing its innovative prostate cancer therapies. The events include:
- Jefferies London Healthcare Conference: November 17, 2022, at 3:15 p.m. GMT.
- Piper Sandler 34th Annual Healthcare Conference: November 29, 2022, at 4:30 p.m. ET.
David R. Parkinson, CEO, along with other executives, will host one-on-one meetings. A live webcast of the Jefferies chat will be available on ESSA's website, archived for 90 days.
ESSA Pharma Inc. (NASDAQ: EPIX) reported on October 31, 2022, that Janssen Research and Development has suspended enrollment in the Phase 1 clinical study of EPI-7386 in advanced prostate cancer due to recruitment challenges. Despite this setback, three patients treated showed favorable safety and initial clinical activity, with two achieving a 90% reduction in PSA levels within 12 weeks. ESSA plans to continue discussions with Janssen for a potential combination study and retains global rights to EPI-7386, which has received FDA Fast Track designation.
ESSA Pharma Inc. (NASDAQ: EPIX) presented preclinical data for its first generation androgen receptor (AR) degrader, EPI-8207, at the 34th EORTC-NCI-AACR Annual Symposium in Barcelona. The data shows EPI-8207 effectively degrades AR, including splice variants and mutants associated with castration-resistant prostate cancer. This research highlights the potential of ANITAC in targeting AR signaling, a key driver in prostate cancer progression. The study indicates EPI-8207's high potency in inhibiting AR-dependent transcription, positioning ESSA for advancements in prostate cancer therapy.
ESSA Pharma Inc. (NASDAQ: EPIX) announced promising results from a Phase 1/2 trial of its lead candidate, EPI-7386, in combination with enzalutamide for treating metastatic castration-resistant prostate cancer. The study showed that the combination therapy was safe with no dose-limiting toxicities, and 5 out of 6 patients experienced significant prostate-specific antigen (PSA) reductions. The pharmacokinetics indicated minimal impacts on enzalutamide exposure. ESSA is currently enrolling a third dose escalation cohort to optimize the therapeutic dose.
ESSA Pharma Inc. (NASDAQ: EPIX) announced the appointment of Philip Kantoff, M.D., to its Board of Directors, enhancing its leadership in prostate cancer treatment. Dr. Kantoff, a notable oncologist with extensive experience in clinical development, aims to assist ESSA in advancing its pipeline targeting the androgen receptor's N-terminal domain. His previous roles include CEO of Convergent Therapeutics and Chairman at Memorial Sloan Kettering Cancer Center. This strategic addition is expected to bolster ESSA's research and development efforts in prostate cancer therapies.
ESSA Pharma Inc. (NASDAQ: EPIX) provides a corporate update and financial results for Q3 ended June 30, 2022. The company reported a net loss of $8.8 million ($0.20 loss per share), consistent with the previous year. R&D expenditures increased slightly to $6.4 million. ESSA's lead candidate, EPI-7386, advanced to the dose expansion phase of its clinical trial, showing safety and initial anti-tumor activity. Cash reserves stand at $174.6 million, sufficient to fund operations through 2024.
ESSA Pharma Inc. (EPIX) presented promising Phase 1a trial results for EPI-7386, a novel prostate cancer treatment, indicating the drug was well-tolerated and achieved significant efficacy in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Out of 36 participants, the drug showed initial anti-tumor effects with reduced tumor volumes and stable PSA levels. The company plans to initiate a Phase 1b expansion study in Q3 2022. Notably, EPI-7386 may be explored in combination with other therapies to enhance its efficacy against prostate cancer.
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