Executive Summary

ESSA Pharma reported fiscal Q4 2024 net loss of $6.36M and diluted EPS of -$0.14; sequential losses narrowed vs Q3 (-$7.23M; -$0.16 EPS) as operating expenses declined .
The company terminated all masofaniten clinical trials following a futility analysis and withdrew related IND/CTAs; management initiated a strategic alternatives review expected to include cost reductions .
Liquidity remains strong: $126.8M in cash and short-term investments and no long-term debt at Sept 30, 2024; 44.39M shares outstanding .
EPS beat third-party consensus for Q4 2024 (-$0.19) by $0.05; S&P Global consensus estimates were unavailable via our data tool, so we reference MarketBeat for consensus and note S&P Global unavailability. Revenue was not reported (pre-revenue biotech) .
Stock narrative catalyst near-term is progress and disclosures on the strategic review and any potential transactions following program termination .

What Went Well and What Went Wrong

What Went Well

Sequential improvement in losses and operating expense discipline: Q4 total operating expenses fell to $7.70M from $8.64M in Q3; net loss improved to $6.36M from $7.23M .
Robust liquidity and no long-term debt support optionality: $126.8M cash/ST investments; net working capital $124.3M .
Management clarity and decisive action: “We recently made the difficult decision to terminate the clinical development of masofaniten… We are currently evaluating and reviewing our strategic options focused on maximizing shareholder value…” — David Parkinson, MD, President & CEO .

What Went Wrong

Clinical efficacy shortfall: Phase 2 interim showed no clear efficacy benefit for masofaniten + enzalutamide versus enzalutamide alone; futility analysis led to termination of all trials and regulatory withdrawals .
Control arm outperformed expectations: Enzalutamide monotherapy achieved PSA90 of 73% vs 64% for the combo; other PSA endpoints similarly favored control, undermining the combination’s value proposition .
Increased G&A vs prior year: Q4 G&A was $3.51M vs $1.92M in Q4 2023, driven by higher share-based payments and salaries; annual G&A rose to $13.21M from $10.81M .

Financial Results

Income Statement Metrics (Quarterly)

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD)	None reported	None reported	None reported
Research & Development ($USD Millions)	$6.18	$5.48	$4.19
General & Administration ($USD Millions)	$4.32	$3.15	$3.51
Total Operating Expenses ($USD Millions)	$10.49	$8.64	$7.70
Interest and Other ($USD Millions)	$1.50	$1.41	$1.34
Net Loss ($USD Millions)	$(8.99)	$(7.23)	$(6.36)
Diluted EPS ($USD)	$(0.20)	$(0.16)	$(0.14)

Liquidity and Capitalization

Metric	Q2 2024	Q3 2024	Q4 2024
Cash + Short-term Investments ($USD Millions)	$135.9	$130.7	$126.8
Shares Outstanding (period-end)	44,362,991	44,368,959	44,388,550
Long-term Debt	$0 (no long-term debt facilities)	$0 (no long-term debt facilities)	$0 (no long-term debt facilities)

Clinical KPI Highlights (Phase 2 Interim – PSA Endpoints)

Endpoint	Enzalutamide 160mg QD	Masofaniten 600mg BID + Enzalutamide 160mg QD
PSA90 Response Rate*	73%	64%
PSA50 Response Rate*	87%	88%
PSA50 @ 90 days	86%	93%
PSA90 @ 90 days	71%	67%

*PSA90/50 calculated in patients completing at least 1 month of treatment .

EPS vs Estimates

Metric	Q4 2023	Q4 2024 Actual	Q4 2024 Wall St. Consensus	Beat/Miss
EPS ($USD)	$(0.12)	$(0.14)	$(0.19)	+$0.05 vs consensus

Note: S&P Global consensus estimates were unavailable via our data tool at the time of analysis.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Phase 2 (masofaniten + enzalutamide) preliminary data timing	Mid-2025	Report preliminary data mid-2025; complete enrollment Q1 2025	All clinical trials terminated; IND/CTAs withdrawn	Withdrawn
Phase 2 enrollment completion	Q1 2025	Complete enrollment Q1 2025	Program terminated	Withdrawn
Combination arms (abiraterone; apalutamide)	2H 2024+	Ongoing enrollment in additional arms	Terminated in conjunction with masofaniten program	Withdrawn
Strategic direction	N/A	No strategic alternatives process communicated	Comprehensive strategic alternatives process initiated; may include M&A, asset sale, shareholder distribution, wind-up, liquidation; cost reductions expected	New
License Agreement	N/A	Licensed IP in place	License Agreement terminated effective Dec 12, 2024	Terminated
Cash runway	Through/beyond 2025	Cash runway sufficient beyond 2025	$126.8M cash/ST investments; headcount/cost reductions expected under strategic review	Maintained liquidity; cost actions pending

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was found/published; themes below reflect management disclosures across Q2, Q3, and Q4 press releases.

Topic	Previous Mentions (Q2 2024 and Q3 2024)	Current Period (Q4 2024)	Trend
R&D execution	Positive Phase 1 combo tolerability; strong PSA reductions; Phase 2 enrollment underway; data flow expected 2H 2024–mid 2025	Futility analysis; no clear efficacy benefit; all trials terminated	Negative reversal
Product performance (PSA endpoints)	ASCO-GU data: PSA50 88%, PSA90 81%, PSA<0.2ng/mL 63% (Phase 1 combo)	Phase 2 interim: enzalutamide control outperformed expectations (PSA90 73% vs 64% combo)	Deteriorated vs expectations
Cash runway/liquidity	$135.9M (Q2), $130.7M (Q3); runway beyond 2025	$126.8M cash/ST investments; no long-term debt	Stable/strong; gradual draw
Regulatory/legal	Routine forward-looking statements and risk disclosures	License Agreement terminated; initiation of strategic alternatives; expanded risk disclosures	Increased actions
Strategic alternatives	Not highlighted	Strategic review initiated with wide range of options; cost reductions expected	New priority

Management Commentary

“We recently made the difficult decision to terminate the clinical development of masofaniten… We are currently evaluating and reviewing our strategic options focused on maximizing shareholder value and look forward to providing further updates…” — David Parkinson, MD, President & CEO (Dec 17, 2024) .
“We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile… would not likely meet the primary endpoint… nor our internal requirements…” — David Parkinson, MD (Oct 31, 2024) .
“Senior management, together with the board of directors, are actively focused on preserving capital and will initiate a strategic process to explore and review a range of strategic options…” — Richard Glickman, LLD, Chairman (Oct 31, 2024) .

Q&A Highlights

No Q4 2024 earnings call transcript was found; MarketBeat lists a scheduled call on Dec 17, 2024, but a transcript was not available. Management indicates further updates will be provided as the strategic alternatives process advances .

Estimates Context

EPS: Q4 2024 actual EPS was -$0.14; third-party consensus cited by MarketBeat was -$0.19, implying a $0.05 beat. S&P Global consensus data was unavailable through our data tool at time of analysis; thus, we reference MarketBeat and note S&P Global unavailability .
Revenue: ESSA does not report product revenue; statements present operating expenses and interest income only; consensus revenue unavailable .
Implications: Following program termination and anticipated cost reductions under the strategic review, Street estimates may need to adjust operating expense run-rate and EPS trajectory to reflect reduced R&D/G&A and potential strategic transactions; management explicitly expects headcount and other cost reductions .

Key Takeaways for Investors

Sequential P&L improvement: Q4 net loss and opex both declined versus Q3; diluted EPS improved to -$0.14 from -$0.16 as interest income partly offset opex .
Clinical program outcome: Phase 2 interim showed no clear efficacy benefit; all masofaniten trials and related regulatory filings were withdrawn, removing the prior clinical catalyst path .
Strategic review is key near-term: Management launched a broad strategic alternatives process (M&A, asset sale, distribution, wind-up, etc.) and signalled cost reductions; updates to this process are the primary stock narrative driver .
Balance sheet supports optionality: $126.8M cash/ST investments, $124.3M net working capital, and no long-term debt give ESSA runway to execute strategic actions .
EPS beat vs third-party consensus: Q4 EPS (-$0.14) was better than -$0.19 consensus cited by MarketBeat; S&P Global estimates were unavailable via our tool .
Prior guidance withdrawn: Previously expected Phase 2 enrollment completion by Q1 2025 and mid-2025 data are now moot; investors should refocus on strategic outcomes rather than clinical milestones .
Monitor legal/regulatory steps: License Agreement termination and forward-looking risk disclosures underscore evolving corporate posture; diligence on potential liabilities and process costs is warranted .

Cross-Period Comparison (Additional Reference)

Q2 2024: Net loss $8.99M; EPS -$0.20; strong Phase 1 combo data; cash/ST investments $135.9M .
Q3 2024: Net loss $7.23M; EPS -$0.16; Phase 2 enrollment ongoing; cash/ST investments $130.7M .
Q4 2024: Net loss $6.36M; EPS -$0.14; program terminated; strategic review initiated; cash/ST investments $126.8M .

Notes:

Item 2.02 8-K furnished on Dec 17, 2024 attaches the full press release and financial statements for Q4 and FY 2024 .
Revenue is not reported; ESSA is a clinical-stage, pre-revenue company, as evidenced by the absence of a revenue line in the statements .
S&P Global estimates were unavailable via the tool; where consensus is referenced, we cite MarketBeat and explicitly note S&P unavailability .

ESSA Pharma Inc. (EPIX)·Q4 2024 Earnings Summary