ACTU 8-K SEC Filing Analysis

Latest settled — T+5d

ACTU ▼ -15.92% at T+5d

NEUTRAL call ✗ call lost -15.92% · α vs SPY -15.99% · entry $2.89 → $2.43

Next anchor: T+20d due 19h ago

Last close $1.82 (close Jun 8) · -37.02% from $2.89 entry

Entry anchored
May 11, 2026
via day open

T+1d

0.00%

call 0.00% · α -0.54%

$2.89

settled 29d ago

T+5d

-15.92%

call -15.92% · α -15.99%

$2.43

settled 23d ago

T+20d

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call — · α —

—

due 19h ago

T+60d

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call — · α —

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in 8w

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Executive Summary

Actuate Therapeutics announced FDA clearance of an Investigational New Drug (IND) application to conduct a Phase 1/2 study of its oral elraglusib tablet formulation in advanced solid tumors, with initiation planned for 2H 2026. The company also reported positive Phase 2 data in metastatic pancreatic cancer (mPDAC) showing elraglusib + GnP doubled 1-year overall survival vs GnP alone (44.4% vs 22.3%, p=0.0004) and improved median OS by 40% (HR 0.62, p=0.02). However, the filing explicitly states the company's financial condition raises substantial doubt about its ability to continue as a going concern, requiring additional capital to fund operations beyond July 2026.

Actionable Insight

The FDA IND clearance for oral elraglusib is a meaningful clinical milestone that de-risks the oral formulation pathway, but the going concern disclosure (cash only through July 2026) creates existential near-term risk. The strong Phase 2 mPDAC data supports the drug's potential, but the company will likely need to raise capital via dilutive financing within weeks/months. Monitor for equity offering announcements and upcoming RAS inhibitor synergy data expected mid-2026.

Key Facts

FDA cleared IND for Phase 1/2 study of oral elraglusib tablet in advanced solid tumors (melanoma, NSCLC, colorectal, pancreatic cancers), initiation planned for 2H 2026
Phase 2 RCT in 1L mPDAC (n=233) met primary endpoint: elraglusib + GnP doubled 1-year OS vs GnP alone (44.4% vs 22.3%, p=0.0004)
Elraglusib + GnP improved median OS by 40% vs GnP alone (HR 0.62, p=0.02)
2.5x increase in 1-year OS in patients with liver metastases (p=0.0003)
Company's financial condition raises substantial doubt about ability to continue as a going concern; requires additional capital to fund operations beyond July 2026
Nonclinical studies show >95% bioavailability for oral tablet formulation
IP provides exclusivity to 2038 before PTE in all major markets
Potential for pediatric review voucher worth $150-200 million
Martin Huber, MD, former CEO of Mersana Therapeutics, joined Board of Directors

Financial Impact

No revenue or earnings reported; company is pre-revenue clinical-stage biotech. Cash runway only through July 2026 per going concern disclosure.

cash runwaygoing concerndilution risk

Risk Factors

Going concern risk: company requires additional capital to fund operations beyond July 2026
Dilution risk from likely near-term equity financing given $78M market cap and limited cash runway
Clinical risk: oral formulation Phase 1/2 data may not replicate IV formulation efficacy
Regulatory risk: no assurance of FDA/EMA approval for any indication
Single-product dependency on elraglusib

Market Snapshot

Exchange

Nasdaq

Sector

Pharmaceutical Preparations

Analyst Consensus

90% bullish (10 analysts)

Documents Analyzed

This report is based on 6 SEC documents filed with EDGAR.

Document	Accession Number
8-K Filing (Primary)	0001683168-26-003684
Document: actuate_8k.htm	0001683168-26-003684
Document: actuate_ex9901.htm	0001683168-26-003684
Document: 0001683168-26-003684-index-headers.html	0001683168-26-003684
Document: 0001683168-26-003684-index.html	0001683168-26-003684
Document: 0001683168-26-003684.txt	0001683168-26-003684

6 reports for ACTU

T+1T+5T+20T+60

Track record builds as more directional reports settle.

Filters

Reports for ACTU — sortable, filterable
	Type				Now
Jun 9, 2026 today	Press Release BULLISH ★ 7/10	$1.82 awaiting T+5	awaiting T+5	—	$1.82 (+0.00%)
May 11, 2026 29d ago	8-K MIXED ★ 7/10	$2.89 $2.43	▼ −15.92%	▼ −15.99%	$1.82 (−37.02%)
May 6, 2026 4w ago	DEFA14A NEUTRAL ★ 4/10	$2.99 $2.89	▼ −3.34%	▼ −4.48%	$1.82 (−39.13%)
May 6, 2026 4w ago	8-K NEUTRAL ★ 4/10	$2.99 $2.89	▼ −3.34%	▼ −4.48%	$1.82 (−39.13%)
Apr 14, 2026 8w ago	Press Release BULLISH ★ 8/10	$2.08 $2.27	▲ +8.89%	▲ +7.50%	$1.82 (−12.50%)
Mar 9, 2026 13w ago	Press Release NEUTRAL ★ 4/10	$2.95 $2.68	▼ −9.00%	▼ −7.64%	$1.82 (−38.20%)

US Market Status

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