Business Context and Reporting Period
Company: Shuttle Pharmaceuticals Holdings, Inc. (SHPH)
Filing Type: Form 8-K (Current Report)
Date of Report: January 23, 2025
Reporting Period: Event date January 23, 2025; Change Order effective February 1, 2025.
Context: The Company, an emerging growth company, reported the entry into a Change Order with Theradex Systems, Inc., a contract research organization (CRO), regarding its Phase 2 clinical trial for Ropidoxuridine.
Key Financial Metrics
This filing does not contain financial statements, revenue, profit, cash flow, margin, debt, or liquidity metrics. The document focuses exclusively on a contractual amendment for a clinical trial.
Material Changes
The Company entered into a Change Order to a previously disclosed Work Order with Theradex Systems, Inc. Key modifications include:
- Patient Count: Increased from 15 to 16 patients in the Phase 2 study due to the inclusion of a replacement patient.
- Study Sites: Increased the number of sites in the "Phase 2 - Start up" phase from four to six.
- Procedural Additions: Added one investigator site and one safety teleconference per activity to facilitate medical monitor review of safety data.
- Budget Impact: The Change Order includes small budget increases attributed to the additional sites and pass-through costs for increased travel related to regulatory visits.
Guidance, Outlook, and Risks
Outlook: The filing indicates continued progression of the Phase 2 Study of Ropidoxuridine as a radiation sensitizing agent for patients with newly diagnosed IDH-Wildtype Glioblastoma with unmethylated MGMT Promotor.
Risks and Contingencies: The filing notes that certain portions of the Change Order exhibit have been redacted as they are considered private or confidential. No specific financial risks or forward-looking guidance regarding revenue or timelines were provided in this text.
Investor Verification Checklist
- Verify the total financial impact of the budget increases mentioned in the Change Order (specific dollar amounts are not disclosed in the summary text).
- Review the full text of Exhibit 10.1 (Change Order) for detailed cost breakdowns and redacted confidential terms.
- Confirm the current enrollment status of the Phase 2 study to assess the significance of the patient count increase.
- Monitor future filings for any material changes to the study timeline resulting from the addition of sites and patients.