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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) presented promising preclinical data for its lead candidate, EPI-7386, at the 2021 AACR Annual Meeting. This investigational drug is a selective inhibitor of the androgen receptor's N-terminal domain, showing high potency and specificity. Key findings include EPI-7386’s capability to inhibit androgen receptor binding to DNA and its effectiveness against various splice variants linked to prostate cancer. The company is currently conducting a Phase 1 clinical trial for metastatic-castration resistant prostate cancer, with further studies planned in collaboration with Janssen and Astellas.
ESSA Pharma Inc. (Nasdaq: EPIX) announced the resignation of Dr. Ari Brettman from its Board of Directors, effective March 26, 2021. Dr. Brettman, a Managing Director at Blackstone's Life Science Group, has been with the Board since 2019. ESSA's Chairman, Richard M. Glickman, expressed gratitude for Dr. Brettman's leadership and insights during his tenure. Dr. Brettman acknowledged the company's growth and highlighted the potential of ESSA's lead candidate, EPI-7386, to transform prostate cancer treatment.
ESSA Pharma Inc. (Nasdaq: EPIX) announced the exercise of an option by underwriters to purchase an additional 724,637 common shares from its recent public offering, bringing total shares issued to 5,555,555 and gross proceeds to approximately $150 million. The offering, which closed on February 22, 2021, will fund clinical activities, including combination studies with EPI-7386 and anti-androgens. Jefferies and Piper Sandler were the joint book-running managers for the offering. Full prospectus details can be found on the SEC and SEDAR websites.
ESSA Pharma Inc. (NASDAQ: EPIX) announced the results of its Annual General Meeting held on February 25, 2021. Shareholders re-elected the board of directors with significant majority support, including David R. Parkinson and Richard M. Glickman, among others. Key approvals included the re-appointment of Davidson & Company LLP as auditors, a new omnibus incentive plan, and amendments to the existing stock option plan. ESSA focuses on developing innovative therapies for prostate cancer, a significant medical area with rising treatment challenges.
ESSA Pharma Inc. (NASDAQ: EPIX) announced that President and CEO Dr. David R. Parkinson will present at three virtual investor conferences in March 2021. The conferences include the Cowen 41st Annual Health Care Conference on March 4 at 12:10 p.m. ET, the H.C. Wainwright Annual Global Life Sciences Conference on March 9 at 7:00 a.m. ET, and the Oppenheimer 31st Annual Healthcare Conference on March 18 at 11:20 a.m. ET. Webcasts will be accessible on the ESSA website and archived for 90 days after each event.
ESSA Pharma Inc. (Nasdaq: EPIX) has announced a clinical collaboration with Astellas Pharma Inc. to evaluate EPI-7386, a novel androgen receptor inhibitor, in combination with enzalutamide for treating metastatic castration-resistant prostate cancer (mCRPC). This Phase 1/2 study is set to begin in 2021 and aims to assess the safety, tolerability, and preliminary efficacy of the combination therapy in patients who haven't received second-generation antiandrogens. ESSA retains all rights to EPI-7386, which has received Fast Track designation from the FDA.
ESSA Pharma Inc. (Nasdaq: EPIX) has successfully closed a public offering of 4,830,918 common shares at $27.00 per share, raising approximately $130 million in gross proceeds. The Company has granted underwriters a 30-day option for an additional 724,637 shares. Funds will be allocated toward clinical activities including multiple studies with EPI-7386, a Phase 2 clinical study, and preparatory work for a Phase 3 study. Jefferies and Piper Sandler served as joint book-running managers for this Offering.
ESSA Pharma Inc. (Nasdaq: EPIX) announced a public offering of 4,830,918 common shares priced at $27.00 per share, totaling approximately $130.4 million. The underwriters have a 30-day option to purchase an additional 724,637 shares. After expenses, the net proceeds are expected to be around $121.6 million, aimed at funding pre-clinical and clinical activities, R&D, as well as general corporate purposes. The offering is set to close around February 22, 2021.
ESSA Pharma Inc. (Nasdaq: EPIX) has initiated a public offering to sell up to $100 million of its common shares. The proceeds will support clinical and pre-clinical activities, along with R&D, manufacturing, and general corporate needs. The offering includes a potential 30-day option for underwriters to acquire an additional 15% of the shares. Jefferies and Piper Sandler lead the offering, which is contingent on market conditions. The shares will be made available under an effective shelf registration statement filed with the SEC.
ESSA Pharma Inc. (NASDAQ: EPIX) presented promising preclinical and clinical data for EPI-7386 at the 2021 ASCO GU Cancers Symposium, relating to its Phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC). EPI-7386 was well-tolerated in the initial 200 mg cohort with no serious adverse events. Notably, one patient showed over a 50% decline in prostate-specific antigen (PSA) levels after 12 weeks. The company plans further evaluation at higher doses, with more data anticipated in the second half of 2021.
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