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Jun 30, 2024
Essa Pharma Q3 2024 Earnings Report
Provided a corporate update and reported financial results for the fiscal third quarter.
Key Takeaways
ESSA Pharma is progressing towards significant milestones, including the presentation of mature durability data from the Phase 1 dose escalation study and the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide.
On track to report updated Phase 1 masofaniten plus enzalutamide dose escalation data in patients with mCRPC naïve to second generation antiandrogens in the second half of 2024.
Presentation of Phase 1b monotherapy results expected to be reported in the second half of 2024.
Phase 2 dose expansion underway evaluating masofaniten plus enzalutamide in patients with mCRPC naïve to second generation antiandrogens; ESSA projecting completion of enrollment in the first quarter of 2025, with preliminary data expected in mid-2025.
Cash runway sufficient to fund operations well beyond 2025.
Essa Pharma
Essa Pharma
Forward Guidance
ESSA Pharma anticipates a stream of significant milestones over the next nine to twelve months, with ongoing studies and data presentations expected to drive progress.
Positive Outlook
- Presentation at ESMO of more mature durability data from the Phase 1 dose escalation study evaluating masofaniten combined with enzalutamide in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens.
- Focus on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 25 sites activated in the US, Canada and Australia and an additional 14 sites being activated in Europe.
- Reporting key data across these trials throughout the remainder of this year through 2025.
- Advancement and evaluation of masofaniten.
- Obtaining necessary regulatory approvals.
Challenges Ahead
- Various known and unknown risks and uncertainties that may cause ESSA's actual results to be materially different.
- Subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies.
- The accuracy of ESSA's financial projections.
- Obtaining positive results of clinical trials.
- General business, market and economic conditions.