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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 announced the termination of its Phase 2 clinical trial evaluating masofaniten combined with enzalutamide in metastatic castration-resistant prostate cancer patients. The decision came after a futility analysis showed the enzalutamide control arm performing better than historical controls and similar to the combination therapy, making it unlikely to achieve the primary endpoint. All additional clinical studies with masofaniten will be terminated. The company reported $126.8 million in cash reserves and $124.3 million in net working capital as of September 30, 2024. Management will initiate a strategic review process to maximize shareholder value.
ESSA Pharma presented updated Phase 1/2 clinical data for masofaniten (EPI-7386) in combination with enzalutamide at the 2024 ESMO Congress. The study focused on patients with metastatic castration-resistant prostate cancer (mCRPC). Key findings include:
- 88% of patients achieved PSA90
- 69% achieved PSA90 in less than 90 days
- 63% achieved PSA <0.2ng/mL
- After 15.2 months, median time to PSA progression and radiographic progression-free survival not yet reached
- Combination well-tolerated with durable PSA reductions
- Phase 2 dose expansion ongoing at RP2CDs of masofaniten 600 mg BID with enzalutamide 160 mg QD
The data suggests favorable outcomes compared to historical single-agent enzalutamide treatment in mCRPC patients.
ESSA Pharma (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for prostate cancer treatment, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company will present on September 18, 2024, at 9:10 a.m. ET in New York, NY.
Key executives participating in a fireside chat include David R. Parkinson (President and CEO), Peter Virsik (COO and EVP), and David S. Wood (CFO). A live webcast of the event will be available on ESSA's website in the Investors/Events & Presentations section, and will remain archived for 90 days post-event.
ESSA Pharma (NASDAQ: EPIX) provided a corporate update and reported financial results for Q3 2024. Key highlights include:
1. On track to report updated Phase 1 masofaniten plus enzalutamide data in mCRPC patients in H2 2024.
2. Phase 1b monotherapy results expected in H2 2024.
3. Phase 2 dose expansion ongoing; enrollment completion projected for Q1 2025, with preliminary data expected mid-2025.
4. Q3 2024 net loss of $7.2 million, compared to $7.3 million in Q3 2023.
5. R&D expenses decreased to $5.5 million from $6.3 million year-over-year.
6. Cash reserves of $130.7 million as of June 30, 2024, sufficient to fund operations beyond 2025.
ESSA Pharma (NASDAQ: EPIX), a clinical-stage pharmaceutical company aimed at developing innovative prostate cancer treatments, announced its participation in the JonesHealthcare Seaside Summit. The event will take place on July 15, 2024, at 11:00 a.m. PT. The company's President and CEO, David R. Parkinson, will lead the presentation and join a panel discussion titled 'Innovations and Challenges in Prostate Cancer' at 9:00 a.m. PT. The presentation will be webcast live on the Investors/Events & Presentations section of the ESSA Pharma website and will remain archived for 90 days post-event. However, the panel discussion will not be available via webcast.
ESSA Pharma (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for prostate cancer, announced it will present at the Jefferies Global Healthcare Conference on June 6, 2024, at 12:30 p.m. ET in New York.
Company executives David R. Parkinson (President & CEO) and David S. Wood (CFO) will host and participate in one-on-one meetings.
The event will be webcast live and available on the ESSA website for 90 days.
ESSA Pharma (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on prostate cancer therapies, reported its financial results for the second fiscal quarter ending March 31, 2024. Highlights include the promising Phase 1 data for masofaniten plus enzalutamide, showing a deep and durable reduction in PSA levels among mCRPC patients. Key achievements include 81% of patients achieving PSA90. ESSA forecasts the completion of Phase 2 enrollment by 1Q25, with preliminary data expected in mid-2025. Financially, ESSA experienced a net loss of $9.0 million, up from $7.1 million the previous year, due to increased R&D and G&A expenses. The company holds $135.9 million in cash reserves, enough to fund operations beyond 2025.
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