EPIX: Risk Profile of Patients in Phase 1/2 Trial of Masofaniten Reveals Majority at High Risk for Early Enzalutamide Failure…

By David Bautz, PhD

NASDAQ:EPIX

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Business Update

Majority of Patients in Phase 1/2 Clinical Trial of Masofaniten at High Risk for Early Enzalutamide Failure

In January 2024, ESSA Pharma Inc. (NASDAQ:EPIX) announced that updated Phase 1/2 clinical trial data for masofaniten (formerly EPI-7386) in combination with enzalutamide (Enz) was presented at the 2024 ASCO Genitourinary Cancers Symposium. A copy of the poster presentation can be found here and an analysis of the data can be found in our previous report here.

Included in the poster was a risk assessment of the patients in the Phase 1/2 study using risk criteria that were developed from the PREVAIL trial and recently used in the ENZA-p study (Emmett et al., 2021). A total of 14/18 participants in the masofaniten Phase 1/2 study had ≥ 2 risk factors of early treatment failure on enzalutamide (e.g., were high risk for early failure), which are given below:

•     LDH >= upper limit of normal

•     ALP >= upper limit of normal

•     Albumin <35 g/L

•     De novo metastatic disease at diagnosis

•     <3 years since initial diagnosis

•     >5 bone metastases

•     Visceral metastases

•     PSA doubling time <84 days

What this means is that the patient cohort in the Phase 1/2 trial was not composed of ‘easier to treat’ patients and that comparisons to trials that utilized single agent enzalutamide are relevant. Thus, the data presented last month showing that the combination of masofaniten and enzalutamide leads to deep and durable reductions in PSA and (thus far) a greater median time to PSA progression when compared to trials of enzalutamide monotherapy are very compelling results in light of what would normally be expected.

Financial Update

On February 13, 2024, ESSA announced financial results for the first quarter of fiscal year 2024 that ended December 31, 2023. For the first quarter of fiscal year 2024, the company reported a net loss of $6.0 million compared to a net loss of $6.7 million for the first quarter of fiscal year 2023. R&D expenses for the first quarter of fiscal year 2024 were $5.4 million compared to $5.3 million for the first quarter of fiscal year 2023. The increase was primarily due to additional investment in the clinical work on masofaniten partially offset by decreased manufacturing costs and lower non-cash share-based payments. G&A expenses for the first quarter of fiscal year 2024 were $2.2 million compared to $2.5 million for the first quarter of fiscal year 2023. The decrease was primarily due to lower non-cash share-based payments.

As of December 31, 2023, ESSA had approximately $142.1 million in cash, cash equivalents, and short-term investments. We estimate this is sufficient to fund operations beyond 2025. As of February 7, 2023, the company had approximately 44.2 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 55.3 million.

Conclusion

While cross-trial comparisons are difficult, we believe that comparing results from the dose escalation portion of the Phase 1/2 study of masofaniten in combination with enzalutamide to enzalutamide monotherapy trials is valid given the similar patient cohorts and the fact that a majority of the patients had ≥ 2 risk factors for early treatment failure on enzalutamide. We look forward to additional updates from the Phase 1 dose escalation portion of the trial in the second half of 2024 and for guidance from the company on when an update from the Phase 2 portion of the study will be available. With no changes to our model our valuation remains at $29 per share.

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