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EP

ESSA Pharma Inc. (EPIX)·Q3 2024 Earnings Summary

Executive Summary

  • Fiscal Q3 2024 net loss was $7.233M and EPS was $-0.16, an improvement sequentially vs Q2 2024 net loss of $8.990M and EPS of $-0.20; modest YoY improvement vs Q3 2023 net loss of $7.299M and EPS of $-0.17 .
  • No product revenue reported; operating lines comprised R&D and G&A expenses with investment income offsetting losses .
  • Operational guidance maintained: updated Phase 1 combination durability data slated for ESMO in H2 2024, Phase 1b monotherapy results expected in H2 2024, Phase 2 enrollment completion targeted for Q1 2025 with preliminary data in mid-2025 .
  • Liquidity remains strong with cash reserves and short‑term investments of $130.7M; management states runway sufficient to fund operations beyond 2025 .
  • Wall Street consensus (S&P Global) was unavailable at time of retrieval; vs-estimates comparisons are omitted pending access.

What Went Well and What Went Wrong

What Went Well

  • Sequential loss improvement (Q3 net loss $7.233M vs $8.990M in Q2) and narrower EPS loss ($-0.16 vs $-0.20), aided by investment income .
  • R&D expenses decreased YoY (Q3 $5.484M vs $6.271M), reflecting reduced preclinical work as trials advance .
  • Management reaffirmed near-term clinical catalysts and expanded site activations: 25 sites active in US/Canada/Australia with 14 additional planned in Europe and clear timelines through mid‑2025; “we are progressing towards a stream of significant milestones throughout the next nine to twelve months…” — David Parkinson, MD, President & CEO .

What Went Wrong

  • G&A expenses increased YoY (Q3 $3.154M vs $2.639M), driven in part by higher non‑cash share‑based payments .
  • Continued pre‑revenue profile and operating losses (no product revenue line; net loss $7.233M) .
  • Clinical efficacy metrics in Q3 remained “still maturing” with median time to PSA progression reported as 16.6 months based on prior readouts; updated durability data was deferred to ESMO in H2 2024, delaying potential clinical proof catalysts in the quarter .

Financial Results

Income Statement, Liquidity and Operating Metrics (USD Millions unless noted)

MetricQ1 FY2024 (Dec 31, 2023)Q2 FY2024 (Mar 31, 2024)Q3 FY2024 (Jun 30, 2024)
Net Loss ($)$5.964 $8.990 $7.233
Diluted EPS ($)$-0.14 $-0.20 $-0.16
R&D Expense ($)$5.377 $6.178 $5.484
G&A Expense ($)$2.218 $4.316 $3.154
Investment/Interest & Other ($)$1.631 $1.504 $1.405
Cash & Equivalents ($)$35.345 $91.683 $85.985
Cash + Short‑Term Investments ($)$142.1 $135.9 $130.7

Q3 FY2024 vs Prior Quarter (Q2 FY2024) and Prior Year (Q3 FY2023)

MetricQ3 FY2023Q2 FY2024Q3 FY2024
Net Loss ($)$7.299 $8.990 $7.233
Diluted EPS ($)$-0.17 $-0.20 $-0.16
R&D Expense ($)$6.271 $6.178 $5.484
G&A Expense ($)$2.639 $4.316 $3.154

Note: No product revenue reported in these periods (statements of operations present operating expenses and investment income only) .

KPIs (Clinical Efficacy — Phase 1 Combination Data References)

KPIQ1 FY2024Q2 FY2024Q3 FY2024
PSA50 achieved (%)88% 88% 88%
PSA90 achieved (%)81% 81% 81%
PSA90 achieved <90 days (%)69% 69% 69%
PSA <0.2 ng/mL (%)63% 63% 63%
Median time to PSA progression (months)16.6 (maturing) 16.6 (maturing) 16.6 (maturing)
Median follow‑up (months)11.1 11.1 11.1

Subsequent to Q3, ESMO 2024 presented more mature data (n=16) with PSA90 rising to 88% and median time to PSA progression not reached at 15.2 months; RP2CD set at masofaniten 600 mg BID + enzalutamide 160 mg QD .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance (Q3 FY2024)Change
Updated Phase 1 masofaniten + enzalutamide durability dataH2 2024Report updated data in H2 2024 On track to present at ESMO 2024 in H2 2024 Maintained
Phase 1b monotherapy resultsH2 2024Present complete Phase 1a/1b results in H2 2024 Present complete Phase 1b results in H2 2024 Maintained
Phase 2 dose expansion enrollment completionQ1 2025Expected completion in Q1 2025 Projecting completion in Q1 2025 Maintained
Preliminary Phase 2 data (combination vs enzalutamide)Mid‑2025Preliminary data mid‑2025 Preliminary data mid‑2025 Maintained
Cash runwayBeyond 2025Sufficient beyond 2025 Sufficient well beyond 2025 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Masofaniten + enzalutamide efficacy/tolerabilityPhase 1 dose escalation showed deep and durable PSA reductions; combination well‑tolerated; PSA50 88%, PSA90 81% Continued emphasis on updated durability data and ESMO timing; efficacy metrics reiterated as “maturing” Maintained focus; durability update scheduled
Phase 2 expansion and site activationOpen‑label randomized 2‑arm design; ~120 patients; ~25 sites active; RP2CD masofaniten 600 mg BID + enzalutamide 160 mg QD 25 sites active across US/Canada/Australia; +14 European sites planned by Q3 2024; enrollment completion targeted Q1 2025 Geographic expansion; steady enrollment
Additional combination arms & investigator‑sponsored trialsAbiraterone/prednisone and apalutamide arms; darolutamide neoadjuvant and enzalutamide in mCSPC studies initiated/enrolling Ongoing enrollment in abiraterone/prednisone and apalutamide arms; investigator‑sponsored darolutamide and enzalutamide studies enrolling Pipeline breadth maintained
Liquidity & runwayCash + ST investments $142.1M; runway beyond 2025 Cash + ST investments $130.7M; runway beyond 2025 Strong but modestly declining balances; runway intact

Management Commentary

  • “With continued focus on execution, we are progressing towards a stream of significant milestones throughout the next nine to twelve months, with the first being the presentation at ESMO of more mature durability data…” — David Parkinson, MD, President & CEO .
  • “We are focused on the enrollment of the Phase 2 dose expansion study… with 25 sites activated in the US, Canada and Australia and an additional 14 sites being activated in Europe.” — David Parkinson, MD, President & CEO .
  • Liquidity: “As of June 30, 2024, the Company had available cash reserves and short‑term investments of $130.7 million… sufficient to fund operations beyond 2025” .

Q&A Highlights

  • No formal Q&A content was provided in the company’s Q3 press release; commentary was limited to prepared statements, timelines, and financials .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 FY2024 EPS and revenue was unavailable at time of retrieval; vs‑estimate comparisons are omitted pending access. We default to S&P Global for consensus when available.

Key Takeaways for Investors

  • Sequential improvement: Q3 net loss ($7.233M) and EPS ($-0.16) improved vs Q2 ($8.990M, $-0.20), suggesting disciplined OpEx and supportive investment income into the quarter .
  • R&D tightening YoY (Q3 $5.484M vs $6.271M) indicates pivot from preclinical to clinical execution; monitor spend mix as Phase 2 progresses .
  • Near‑term clinical catalysts could drive stock narrative: ESMO 2024 update (durability), Phase 1b monotherapy results (H2 2024), Phase 2 enrollment completion (Q1 2025), preliminary data (mid‑2025) .
  • G&A YoY increase ($3.154M vs $2.639M) bears watching; largely non‑cash share‑based payments contributed — important for modeling OpEx trajectory .
  • Strong liquidity with $130.7M cash + ST investments and runway beyond 2025 reduces near‑term financing risk; track balances vs enrollment ramp .
  • Pre‑revenue profile persists; operating losses remain until definitive efficacy readouts and potential registration path emerge .
  • Trading lens: catalysts are timing‑certain and near‑term (ESMO, H2 2024), so watch for data‑driven volatility and positioning ahead of readouts .