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Aprea Therapeutics, Inc. (APRE)·Q1 2025 Earnings Summary
Executive Summary
- Q1 2025 delivered continued clinical progress: ATRN-119 showed early single-agent anti-tumor activity with tumor shrinkage of 7%, 14%, and 21% in the 550 mg BID cohort, while APR-1051 advanced dose escalation to 100 mg QD with preliminary efficacy data expected in H2 2025 .
- Financially, grant revenue was $0.162M and net loss was $3.93M ($0.66 EPS); opex increased YoY on trial activity (R&D $2.48M vs $1.60M YoY), while G&A declined slightly YoY to $1.76M .
- Liquidity improved relative to prior guidance: cash and equivalents were $19.3M at March 31, 2025, with runway into early Q2 2026 (vs prior guidance of runway into Q1 2026 as of Q4 2024) — a guidance raise on runway duration .
- Estimates context: Street revenue consensus for Q1 was $0.0*, making the reported $0.162M a trivial beat; EPS consensus was unavailable*, and 2 analysts had an average target price of $10.5* [GetEstimates]*.
- Near-term catalysts that can move the stock: open-label safety/efficacy readouts in H2 2025 for APR-1051 and ATRN-119, and RP2D selection expected in H1 2026 .
What Went Well and What Went Wrong
What Went Well
- “2025 is off to a strong start with significant clinical progress across both of our lead therapeutic candidates,” CEO Oren Gilad said, citing early evidence of single-agent activity for ATRN-119 and ongoing enrollment in APR-1051 .
- ATRN-119 demonstrated measurable tumor reductions at a dose below the anticipated RP2D (21% leiomyosarcoma with RB1/ATM, 14% acinar cell pancreatic with ATM, 7% ovarian with BRIP1) — positive signal early in dose escalation .
- Liquidity runway extended: $19.3M cash and equivalents at quarter-end, supporting operations into early Q2 2026 — longer than prior guidance (Q1 2026) .
What Went Wrong
- Losses widened YoY: operating loss rose to $4.09M (vs $3.15M YoY), net loss to $3.93M (vs $2.81M YoY), driven by higher R&D tied to two active clinical programs .
- Grant revenue contracted YoY ($0.162M vs $0.381M YoY), offering limited offset to increased opex .
- Weighted-average share count rose to ~5.99M from ~4.20M YoY, diluting per-share metrics despite similar EPS YoY ($0.66 vs $0.67) .
Financial Results
P&L and EPS trend vs prior periods and estimates
Notes: Gross margin and EBITDA margins are not applicable given minimal grant revenue and clinical-stage model (no product sales).
Liquidity and balance sheet KPIs
Estimates vs actuals (S&P Global)
Estimates disclaimer: Values retrieved from S&P Global*. EPS coverage was unavailable*.
Guidance Changes
Earnings Call Themes & Trends
Note: No Q1 2025 earnings call transcript was found; themes compiled from Q3/Q4 2024 and Q1 2025 earnings materials and press releases.
Management Commentary
- “In our ongoing ATRN-119 clinical program, three patients in the latest twice daily cohort demonstrated stable disease, with tumor shrinkage of 7%, 14% and 21%, marking early evidence of single agent, anti-tumor activity.” — Oren Gilad, Ph.D., President and CEO .
- “Given the encouraging tolerability profile to date, we are in a position to accelerate dose escalation and explore higher doses, potentially improving APR-1051 therapeutic impact.” .
- “Enrollment of the first patient with HPV+ head and neck cancer in the Phase 1 ACESOT-1051 trial is an important step… We continue to believe that APR-1051 has best in class potential.” — Philippe Pultar, MD .
- “The addition of twice daily dosing represents a proactive step to de-risk the trial, potentially increasing the probability of success.” — Oren Gilad, Ph.D. (Dec 2024) .
Q&A Highlights
- No Q1 2025 earnings call transcript was available; therefore, no Q&A themes could be extracted. Commentary herein is based on earnings releases and corporate materials .
Estimates Context
- Revenue vs consensus: Reported $0.162M vs $0.0* consensus — a nominal beat given biotech grant revenue scale [GetEstimates]*.
- EPS: No Q1 2025 EPS consensus was available*; reported EPS was $(0.66) .
- Coverage/targets: Two analysts with an average target price of $10.5* [GetEstimates]*.
- Implication: With minimal top-line and absent EPS consensus, investors will anchor on clinical readouts and cash runway; estimate revisions likely focus on R&D timing rather than P&L magnitude .
Estimates disclaimer: Values retrieved from S&P Global*.
Key Takeaways for Investors
- Clinical signals are emerging for ATRN-119 (7–21% tumor shrinkage at sub-RP2D) — watch H2 2025 open-label safety/efficacy readout for validation and potential narrative inflection .
- APR-1051 dosing is accelerating (100 mg QD with plan for 150 mg), supported by tolerability, with preliminary efficacy data targeted for H2 2025 — potential best-in-class WEE1 profile would be a valuation driver .
- Liquidity runway was extended to early Q2 2026, reducing near-term financing risk and supporting execution to RP2D milestones in H1 2026 .
- P&L pressure persists as trials ramp (R&D up YoY), with limited grant revenue — expect opex-led losses until clinical catalysts translate into partnership or funding events .
- Academic collaboration (MD Anderson) and expanding IP underpin optionality in HNSCC and broader DDR targets; combination strategies (e.g., with ICIs) may broaden the path forward .
- Trading lens: H2 2025 data readouts are key catalysts; interim updates on dosing cohorts (especially BID ATRN-119) can drive sentiment and estimate recalibration .
- Risk monitoring: dose-limiting toxicities, tolerability at higher doses, and enrollment pace — management indicates favorable profiles to date, but continued vigilance is warranted .