ESSA Pharma Updates and Reports Fiscal Q3 2024 Financial Results

ESSA Pharma Inc., based in South San Francisco, California and Vancouver, Canada, is a clinical-stage pharmaceutical company concentrating on developing innovative therapies for prostate cancer. Recently, ESSA provided a corporate update and financial results for the third fiscal quarter, ending June 30, 2024.

Dr. David Parkinson, President and CEO of ESSA, highlighted the company's progress towards several significant milestones expected over the next nine to twelve months. The initial key milestone involves presenting more mature durability data from the Phase 1 dose escalation study of masofaniten combined with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who are naïve to second-generation antiandrogens. This data will be presented at the European Society for Medical Oncology (ESMO) 2024 Congress.

ESSA is actively working on the enrollment for the Phase 2 dose expansion study, which evaluates masofaniten in combination with enzalutamide. Currently, 25 sites are activated across the US, Canada, and Australia, with an additional 14 sites being prepared in Europe. The company expects to report key data from these trials through the remainder of this year and into 2025.

The ongoing Phase 1/2 study is investigating masofaniten combined with enzalutamide in patients with mCRPC who have not been treated with second-generation antiandrogens but may have received chemotherapy in the metastatic castration-sensitive setting. Results presented at the ASCO-GU symposium in January 2024 indicated that the combination regimen is well tolerated at the administered dose levels, with some patients undergoing up to 25 cycles of dosing. Significant reductions in PSA levels were observed in the evaluable patients across all dosing cohorts. Specifically, 88% of patients achieved PSA50, 81% achieved PSA90, and 63% achieved PSA levels of less than 0.2 ng/mL. The median time to PSA progression was recorded at 16.6 months with a median follow-up of 11.1 months.

The Phase 2 portion of this study, which randomizes patients to receive either the combination therapy or enzalutamide monotherapy, is projected to complete enrollment by the first quarter of 2025. Preliminary data from this phase is expected by mid-2025.

Additional masofaniten combination arms are being evaluated in the ongoing Phase 1 study. One arm investigates masofaniten combined with abiraterone acetate and prednisone in patients with either metastatic castration-sensitive prostate cancer or mCRPC. Another arm assesses masofaniten with apalutamide in non-metastatic castration-resistant prostate cancer patients after 12 weeks of masofaniten monotherapy. Furthermore, two investigator-sponsored studies are currently enrolling to explore combinations of masofaniten with darolutamide or enzalutamide in various patient groups.

ESSA is also on schedule to finalize the Phase 1b monotherapy study of masofaniten for patients with mCRPC resistant to second-generation antiandrogens. Initial results presented at the 2023 ASCO-GU Symposium indicated that the monotherapy was well-tolerated, achieved significant clinical exposures, and showed preliminary anti-tumor activity in some patients.

Financially, ESSA reported a net loss of $7.2 million for the third quarter of 2024, slightly less than the $7.3 million loss reported for the same period in 2023. Research and development expenditures decreased to $5.5 million from $6.3 million, largely due to reductions in preclinical activities. General and administrative expenses rose to $3.2 million from $2.6 million, influenced by non-cash costs related to share-based payments.

As of June 30, 2024, ESSA had cash reserves and short-term investments amounting to $130.7 million, sufficient to fund operations well beyond 2025. The company had 44,368,959 common shares outstanding and an additional 2,920,000 shares issuable upon the exercise of pre-funded warrants.

ESSA continues its focus on developing advanced therapies for prostate cancer, with numerous studies and trials underway that promise to contribute significantly to the field in the coming years.