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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) announced financial results for Q1 2021, reporting a net loss of $6.5 million ($0.20 loss per share) and increased R&D expenses of $4.5 million due to the Phase 1 trial of EPI-7386. The company raised $48.9 million in a public offering and received FDA Fast Track Designation for EPI-7386. A collaboration with Janssen Research will evaluate EPI-7386 with existing therapies for metastatic castration-resistant prostate cancer. ESSA's cash reserves stood at $74.5 million as of December 31, 2020.
ESSA Pharma Inc. (Nasdaq: EPIX) announced a collaboration with Janssen Research & Development to evaluate its androgen receptor inhibitor, EPI-7386, in combination with apalutamide and abiraterone acetate for metastatic castration-resistant prostate cancer (mCRPC) patients. Janssen will sponsor two Phase 1/2 studies, covering all associated costs except EPI-7386's manufacturing expenses. The trials are set to start in 2021, and ESSA retains all rights to EPI-7386. EPI-7386 has received Fast Track designation from the FDA for mCRPC treatment.
ESSA Pharma Inc. (NASDAQ: EPIX) reported a net loss of $23.4 million for the fiscal year ending September 30, 2020, compared to $12.8 million in the previous year. The increase in loss is attributed to rising Research and Development (R&D) expenditures, which reached $12.1 million, and General and Administration (G&A) expenses of $11.4 million. The company received FDA Fast Track Designation for its drug EPI-7386 and raised $48.9 million in a public offering to support its clinical studies. As of September 30, 2020, ESSA had cash reserves of $78.3 million.
ESSA Pharma Inc. (Nasdaq: EPIX) announced its participation in the Evercore ISI 3rd Annual HealthCONx Conference on December 3, 2020, where CEO Dr. David R. Parkinson will present a corporate overview. One-on-one meetings with executives will be available from December 1-3, 2020. The presentation will be accessible via live webcast on the company's Investor Relations page, and a replay will be available for 90 days. ESSA focuses on developing novel therapies for castration-resistant prostate cancer, with recent regulatory approvals for its drug EPI-7386.
ESSA Pharma Inc. (Nasdaq: EPIX), a clinical-stage pharmaceutical company focused on prostate cancer therapies, will present at the Stifel 2020 Virtual Healthcare Conference on November 16, 2020, at 11:00 AM PT, and at the Jefferies Virtual London Healthcare Conference on November 19, 2020, at 10:45 AM PT. CEO Dr. David R. Parkinson will provide a corporate overview. One-on-one meetings will be available from November 16-19. Presentations will be webcast live, with replays accessible for 90 days on www.essapharma.com.
ESSA Pharma Inc. (NASDAQ: EPIX) announced its intention to voluntarily delist its common shares from the TSX Venture Exchange, effective around October 30, 2020. This decision is based on an evaluation revealing that most trading occurs on the NASDAQ, and aims to enhance liquidity, reduce costs, and optimize regulatory compliance. The delisting will not impact the company's NASDAQ listing. ESSA focuses on developing novel therapies for prostate cancer, specifically for patients with advanced disease.
ESSA Pharma Inc. (Nasdaq: EPIX) presented new preclinical data on EPI-7386, an androgen receptor inhibitor, at the 32nd EORTC-NCI-AACR Symposium. The findings show EPI-7386's interaction with both full-length and splice variant androgen receptors, indicating its superior effectiveness compared to enzalutamide in specific prostate cancer cell models. These insights strengthen the rationale for further studies of EPI-7386 in patients with prostate cancer resistant to current therapies. The company is conducting a Phase 1 study of EPI-7386 in metastatic castration-resistant prostate cancer.
ESSA Pharma Inc. (Nasdaq: EPIX) announced that multiple abstracts on its clinical candidate, EPI-7386, have been accepted for presentation at significant medical events. Notable presentations include the 27th Annual Prostate Cancer Foundation Scientific Retreat on October 20, and the 32nd EORTC-NCI-AACR Symposium on October 24, 2020. EPI-7386, a potent androgen receptor inhibitor, is in development for treating prostate cancer, particularly in patients resistant to existing therapies. The data presented may further characterize its preclinical profile and efficacy.
ESSA Pharma Inc. (Nasdaq: EPIX) announced its participation in the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 11:40 am Eastern. Dr. David R. Parkinson, CEO, will present a corporate overview, with key executives available for one-on-one meetings. The presentation will be webcast live, with a replay available for 90 days on ESSA's website. ESSA focuses on developing therapies for castration-resistant prostate cancer and recently filed an IND for EPI-7386.
ESSA Pharma Inc. (Nasdaq: EPIX) presented data on its clinical candidate, EPI-7386, at the ESMO Virtual Congress 2020. The study demonstrated that EPI-7386, a second-generation N-terminal domain androgen receptor inhibitor, provides superior inhibition of AR-associated activity when combined with existing therapies like enzalutamide, apalutamide, and darolutamide. These findings support further exploration of EPI-7386 in earlier lines of prostate cancer treatment. Currently, the company is conducting a Phase 1 study of EPI-7386 in patients with metastatic castration-resistant prostate cancer (mCRPC).
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