Business Context and Reporting Period
Company: Alpha Tau Medical Ltd.
Filing Type: Form 6-K (Report of Foreign Private Issuer)
Date: May 11, 2026
Subject: Announcement of positive interim results from the U.S. Alpha DaRT trial (REGAIN) for patients with recurrent glioblastoma (GBM).
Key Financial Metrics
This filing is a current report regarding clinical trial results and does not contain financial statements. The filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes and Clinical Results
The Company reported interim safety and efficacy data following treatment of three patients (treated in December 2025, February 2026, and March 2026) as of the May 3, 2026 cutoff date:
- Efficacy:
- First two patients demonstrated a continued complete response (total disappearance of enhancing tumor lesions).
- Third patient demonstrated stable disease with a 30% decrease in tumor dimension.
- Overall results reflect 100% local disease control and a 67% complete response rate across the initial cohort.
- No local or distant recurrence or residual symptoms observed.
- Safety:
- One Grade 3 serious adverse event (SAE) observed, which resolved with steroid administration.
- No unanticipated SAEs observed.
Outlook, Risks, and Management Commentary
Regulatory Status: The interim analysis was conducted in accordance with the FDA's request prior to expanding the scope of the Investigational Device Exemption (IDE).
Management Commentary: The Company characterized the results as "groundbreaking" in its press release.
Risks: The filing notes the occurrence of one Grade 3 SAE, though it resolved. As with all clinical trials, future results may vary, and regulatory approval is not guaranteed.
Investor Verification Checklist
- Verify the full text of the press release (Exhibit 99.1) for detailed patient demographics and specific MRI data.
- Confirm the FDA's specific requirements for the next phase of the IDE expansion.
- Monitor upcoming filings for the Company's cash runway and capital requirements, as this filing contains no financial data.
- Review the long-term follow-up data for the three patients to assess durability of the complete response.