Actuate Therapeutics, Inc. Q2 2025 earnings summary — revenue, EPS & margin

What went well

Announced positive topline results in May 2025 from the randomized, controlled Phase 2 Actuate-1801 trial of lead candidate elraglusib plus gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic cancer, which met its primary endpoint with a statistically significant median overall survival benefit (10.1 vs 7.2 months, HR=0.63, log-rank p=0.01), a 12-month survival rate of 44.1% versus 22.3% (p=0.0005) and a 37% reduction in the risk of death versus GnP alone.
Reported a favorable safety profile for the elraglusib/GnP combination, with treatment-related adverse events mostly Grade 1-2 and the most common being transient, reversible visual disturbances.
Completed the Phase 1/2 Actuate-1902 study in refractory pediatric malignancies in July 2025, which identified Ewing sarcoma as a potential second indication for elraglusib.
Narrowed net loss to $5.9 million from $6.6 million a year earlier as research and development expense fell to $2.8 million (from $4.4 million) with the pivotal Phase 2 mPDAC trial completing enrollment.

What went wrong

Ended June 30, 2025 with only $6.5 million in cash and cash equivalents and a $2.5 million working-capital deficit; management and its auditors flagged substantial doubt about the company's ability to continue as a going concern, with existing cash projected to fund operations only into October 2025 without additional capital.
General and administrative expense rose to $3.2 million from $1.1 million a year earlier, reflecting public-company costs following the August 2024 IPO.
Remained dependent on dilutive financings, including a June 2025 private placement (net proceeds of about $4.6 million) and sales under the B. Riley committed equity facility.

Guidance Changes

Metric	Period	Current guidance
Cash runway	As of June 30, 2025	$6.5M in cash; management projected existing cash would not fund operations beyond October 2025 without raising additional capital
Ewing sarcoma program	2026	Plans to advance elraglusib toward a Phase 2 study in relapsed/refractory Ewing sarcoma in 2026, subject to available funding

Metric	YoY	Note
Research & development expense	$2.8M (vs $4.4M)	Lower spend as the Phase 2 Actuate-1801 mPDAC trial completed enrollment.
General & administrative expense	$3.2M (vs $1.1M)	Higher public-company, professional and personnel costs following the August 2024 IPO.
Net loss	$5.9M (vs $6.6M)	Lower R&D more than offset higher G&A.
Diluted net loss per share	$(0.30)	Loss per share on 19.6M weighted-average shares outstanding.
Cash & cash equivalents	$6.5M	Thin runway at June 30, 2025; working-capital deficit of $2.5M.

Topic	Previous mention	Current period	Trend
mPDAC Phase 2 (Actuate-1801)	Enrollment completed; awaiting data	Topline announced May 2025 - met primary OS endpoint	Up
Cash position / going concern	Post-IPO capital	$6.5M cash; going-concern doubt; runway into October 2025	Down
Pediatric program	Phase 1/2 ongoing	Study completed; Ewing sarcoma identified as second indication	Up