What went well
- Presented updated Actuate-1801 mPDAC data at the ASCO Gastrointestinal Cancers Symposium in January 2026 (November 22, 2025 cutoff) showing a statistically significant median overall-survival benefit for elraglusib plus GnP (10.1 vs 7.2 months, p=0.02, HR=0.62), a near-doubling of the 12-month survival rate (44.4% vs 22.3%) and an almost fivefold higher 24-month survival rate (12.9% vs 2.6%).
- Advanced the Elraglusib Oral Tablet, filing an Investigational New Drug (IND) application in April 2026 and receiving FDA clearance to begin a Phase 1/2 dose-finding study in adult patients with advanced, refractory cancers.
- Surpassed 500 patients treated with elraglusib across Phase 1 and Phase 2 studies, reinforcing a favorable safety profile and the company's 'pipeline in a molecule' strategy.
- Held net loss to $5.6 million, narrower than the $6.3 million loss a year earlier.
What went wrong
- Cash fell to $8.1 million at March 31, 2026 (from $13.2 million at year-end) with working capital of $3.8 million; substantial doubt about the company's ability to continue as a going concern continued, with cash projected to fund operations only into July 2026.
- Net loss widened sequentially to $5.6 million (from $4.6 million in the prior quarter) as research and development expense rose to $2.6 million.
- A depressed share price forced dilutive ATM sales at low prices (around $2.68 per share in early 2026), limiting the capital raised relative to shares issued.
Guidance Changes
| Metric | Period | Current guidance |
|---|---|---|
| Cash runway | As of March 31, 2026 | $8.1M in cash; management estimated existing cash would not fund operations beyond July 2026 without raising additional capital |
| Elraglusib Oral Tablet Phase 1/2 | 2026 | FDA-cleared dose-finding study in advanced refractory cancers to identify the recommended Phase 2 dose; multiple Phase 2/registrational studies identified (first-line mPDAC, melanoma, colorectal, NSCLC), subject to funding |
Performance Breakdown
| Metric | YoY | Note |
|---|---|---|
| Research & development expense | $2.6M (vs $3.2M) | Lower clinical spend year over year, with a sequential increase tied to oral-tablet program activities. |
| General & administrative expense | $3.1M (vs $3.1M) | Broadly flat versus the prior-year quarter. |
| Net loss | $5.6M (vs $6.3M) | Lower R&D versus the prior year, though higher than the prior quarter. |
| Diluted net loss per share | $(0.24) | Loss per share on 23.5M weighted-average shares outstanding. |
| Cash & cash equivalents | $8.1M | $8.1M at March 31, 2026; working capital of $3.8M. |
Earnings Call Themes & Trends
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| mPDAC data (ASCO GI) | Topline OS benefit | Matured data showing durable long-term survival benefit at 12 and 24 months | Up |
| Oral tablet program | Formulation in development | IND filed and FDA-cleared for Phase 1/2 dose-finding | Up |
| Cash / going concern | $13.2M; runway into July 2026 | $8.1M cash; runway into July 2026; dilution at low share prices | Down |
More on Actuate Therapeutics, Inc.
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