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Sep 30, 2023
Essa Pharma Q4 2023 Earnings Report
ESSA Pharma reported financial results for the fourth quarter and fiscal year ended September 30, 2023.
Key Takeaways
ESSA Pharma reported on the progress of masofaniten (EPI-7386), its novel N-terminal domain androgen receptor inhibitor, including Phase 1 dose escalation data showing tolerability and PSA reductions when combined with enzalutamide in mCRPC patients. The company is focused on executing the Phase 2 combination study of masofaniten and enzalutamide in mCRPC patients and investigating masofaniten in combination with other standard of care antiandrogens. They anticipate their cash runway will fund planned operations through 2025.
Phase 1 dose escalation is complete for masofaniten/enzalutamide combination study in mCRPC patients.
Compelling safety and efficacy data were reported at Prostate Cancer Foundation 2023 Scientific Retreat and ESMO 2023.
A head-to-head Phase 2 dose expansion is underway evaluating masofaniten/enzalutamide combination versus enzalutamide monotherapy in mCRPC patients.
The company expects its cash runway to fund planned operations through 2025.
Forward Guidance
ESSA Pharma is focused on the Phase 2 combination study of masofaniten and enzalutamide in mCRPC patients and investigating masofaniten in combination with other standard of care antiandrogens. The company’s expected cash runway extends into 2025.
Positive Outlook
- Accuracy of ESSA's financial projections
- Obtaining positive results of clinical trials
- Obtaining necessary regulatory approvals
- General business, market and economic conditions
- Favorable pharmaceutical properties of masofaniten
Challenges Ahead
- Medical uncertainties
- Scientific uncertainties
- Business uncertainties
- Economic uncertainties
- Competitive uncertainties
Historical Earnings Impact
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Avg. Return Before/After Earnings
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