ESSA Pharma Updates and Reports Q2 2024 Financials

ESSA Pharma Inc., a clinical-stage pharmaceutical company dedicated to developing new therapies for prostate cancer, has released a corporate update and financial results for the fiscal second quarter ending March 31, 2024. The company has made significant strides in 2024, particularly with its ongoing studies involving masofaniten in combination with enzalutamide.

David Parkinson, MD, President and CEO of ESSA, highlighted the positive outcomes from the Phase 1 dose escalation study of masofaniten combined with enzalutamide presented at the 2024 ASCO Genitourinary Cancers Symposium. The results demonstrated that the combination is well tolerated and shows profound and lasting reductions in prostate-specific antigen (PSA) levels in patients with metastatic castration-resistant prostate cancer (mCRPC) who have not been treated with second-generation antiandrogens.

Key findings from the Phase 1 study include:
- 88% of patients achieved a 50% reduction in PSA (PSA50).
- 81% achieved a 90% reduction in PSA (PSA90).
- 69% achieved PSA90 within 90 days.
- 63% of patients reached PSA levels below 0.2 ng/mL.

Median time to PSA progression was recorded at 16.6 months, with a median follow-up of 11.1 months. ESSA plans to release further data from this Phase 1 study in the latter half of 2024.

The Phase 2 dose expansion study, which compares masofaniten combined with enzalutamide to enzalutamide monotherapy, is currently in progress. Expected to enroll around 120 patients, the study aims to complete enrollment by the first quarter of 2025, with preliminary data anticipated by mid-2025. The recommended Phase 2 dose is 600 mg of masofaniten taken twice daily, combined with 160 mg of enzalutamide once daily.

Additionally, two more combination arms are part of the ongoing Phase 1 study. One arm is evaluating masofaniten with abiraterone acetate and prednisone in patients with either metastatic castration-sensitive prostate cancer or mCRPC. The other arm is examining masofaniten with apalutamide in patients with non-metastatic castration-resistant prostate cancer post 12 weeks of masofaniten monotherapy.

ESSA is also involved in two investigator-sponsored studies. One in Australia is comparing the neoadjuvant use of masofaniten and darolutamide versus darolutamide monotherapy in high-risk prostatectomy patients. The second study evaluates masofaniten combined with enzalutamide in patients with metastatic castration-sensitive prostate cancer.

The company is on schedule to complete the Phase 1b masofaniten monotherapy study. Preliminary results from this study, presented at the 2023 ASCO-GU Symposium, indicated that masofaniten monotherapy is well tolerated, achieves clinically significant exposures, and shows initial signs of anti-tumor activity. ESSA plans to present comprehensive results from the Phase 1a and 1b monotherapy studies in the second half of 2024.

From a financial perspective, ESSA reported a net loss of $9.0 million for the quarter ending March 31, 2024, compared to a $7.1 million loss for the same period in 2023. This increased loss is attributed primarily to higher investments in clinical trials. Research and development expenditures also rose to $6.2 million in the second quarter of 2024, up from $4.5 million in the same quarter of 2023. General and administrative expenses increased to $4.3 million from $3.7 million a year earlier, mainly due to professional fees for legal and accounting services.

As of March 31, 2024, ESSA had cash reserves and short-term investments totaling $135.9 million, sufficient to fund operations beyond 2025. The company had 44,362,991 common shares issued and outstanding by the end of the period, with an additional 2,920,000 shares issuable upon the exercise of prefunded warrants.

ESSA Pharma Inc. remains focused on developing innovative therapies for prostate cancer, and its ongoing clinical trials and financial health underscore its commitment to advancing treatment options for patients.