What went well
- Maturing interim data from the registrational-intent Phase 2b ACR-368 study showed a confirmed overall response rate of 52% in serous endometrial cancer (N=23) versus 22% in non-serous EC (N=37), featured in a late-breaking oral presentation and KOL panel at the ESGO 2026 Congress.
- Expanded the ACR-368 program with Arm 3 (ACR-368 + ultra-low-dose gemcitabine) enrolling all-comer serous EC patients in the US, EU sites activating, and a newly announced Arm 4 evaluating single-agent ACR-368 in the same biomarker-unselected serous population.
- Reported initial ACR-2316 Phase 1 data with favorable tolerability and clinical activity, including partial responses and disease control in small cell lung cancer and squamous NSCLC.
- Nominated ACR-6840, an oral CDK11 inhibitor, as an internally discovered development candidate and launched a wholly owned CLIA-certified laboratory for companion-diagnostic development.
- Reduced full-year net loss to $77.9 million from $80.6 million and ended the year with $118.6 million in cash, equivalents and marketable securities, expected to fund operations into the second quarter of 2027.
What went wrong
- The company remained pre-revenue with a full-year net loss of $77.9 million and continued cash burn, ending 2025 with $118.6 million versus $184.6 million a year earlier.
- Fourth-quarter net loss was $19.0 million; while lower than the prior year, the company's programs remain in early- to mid-stage development ahead of pivotal readouts.
Guidance Changes
| Metric | Period | Current guidance |
|---|---|---|
| Cash runway | As of December 31, 2025 | $118.6M in cash, equivalents and marketable securities; funds operations into Q2 2027 |
| ACR-368 EU CTA approval (Arm 3) | Q1 2026 | Targeted by the first quarter of 2026 |
| ACR-368 Arm 3 initial data / Arm 1 update | Mid-2026 | Expected mid-2026 |
| ACR-368 Arm 4 (monotherapy serous all-comer) | H1 2026 | Enrollment to initiate in the first half of 2026; Phase 3 confirmatory readiness by mid-2026 |
| ACR-368 Arm 3 enrollment complete (up to N=90) | Q4 2026 | Targeted for the fourth quarter of 2026 |
| ACR-6840 (CDK11) IND filing | Q4 2026 | IND submission to the FDA targeted for the fourth quarter of 2026 |
Performance Breakdown
| Metric | YoY | Note |
|---|---|---|
| Research & development expense (Q4 / FY) | $14.7M / $60.0M (vs $18.6M / $64.0M) | Fewer milestones scheduled and incurred and prioritization of endometrial cancer in the ACR-368 trial. |
| General & administrative expense (Q4 / FY) | $5.4M / $24.1M (vs $6.3M / $25.2M) | Lower personnel costs, including non-cash stock-based compensation. |
| Net loss (Q4 / FY) | $19.0M / $77.9M (vs $22.8M / $80.6M) | Lower operating expenses, partly offset by lower interest income. |
| Cash, equivalents & marketable securities | $118.6M | As of December 31, 2025; funds operations into Q2 2027. |
| Diluted net loss per share (Q4 / FY) | $(0.49) / $(2.02) | On roughly 38.5M weighted-average shares outstanding. |
Earnings Call Themes & Trends
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| ACR-368 in serous endometrial cancer | Arm 3 enrolling | 52% cORR in serous EC; Arm 4 (monotherapy) announced; EU sites activating | Up |
| ACR-2316 Phase 1 | Activity across solid tumors | Initial data showing PRs and disease control in SCLC and squamous NSCLC | Up |
| Pipeline expansion | Undisclosed cell-cycle program | ACR-6840 (CDK11) nominated; CLIA lab launched | Up |
| Cash runway | $134.4M into Q2 2027 | $118.6M into Q2 2027 | Steady |
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