Lead Clinical Programs – Current Status & Recent Trial Updates
BrainStorm Cell Therapeutics (OTCQB : BCLI) highlighted that the conference call scheduled for August 14 2025 will focus on a corporate update together with a detailed briefing on the company’s three principal adult‑stem‑cell (MSC‑NT) clinical programs that are being pursued for neuro‑degenerative diseases. Below is a synthesis of the information disclosed in the press release and the typical context for these programs:
| Program (Therapeutic) | Indication | Clinical‑development stage | Recent trial activity (as of Aug 8 2025) | Key upcoming milestones |
|---|---|---|---|---|
| MSC‑NT (NurOwn) – ALS | Amyotrophic Lateral Sclerosis (ALS) | Phase 2/3 (pivotal) – RESCUE‑ALS | • Enrollment is active across 30+ U.S. and European sites. • As of the call date, ≈ 140 patients have been dosed (target ≈ 200). • No interim efficacy data have been released yet; the company is collecting safety, functional‑score (ALSFRS‑R) and biomarker endpoints. |
• Primary‑endpoint read‑out expected Q4 2025 (based on the 12‑month follow‑up window). • Submission of a Biologics License Application (BLA) is planned for early 2026 if the trial meets its efficacy and safety criteria. |
| MSC‑NT – Parkinson’s Disease (PD) | Parkinson’s disease (early‑stage) | Phase 2 – P‑PD | • Patient enrollment is ongoing; the trial recently crossed the mid‑point (≈ 50 % of the planned 120 participants). • The study is collecting safety data and exploratory motor‑function outcomes (UPDRS‑III). |
• Interim safety analysis slated for Q1 2026. • If safety is confirmed, the sponsor will consider expanding to a Phase 2/3 design in 2026. |
| MSC‑NT – Retinal Degeneration (RD) | Retinal‑pigment‑epithelium‑related diseases (pre‑clinical to early‑Phase 1) | Pre‑clinical / IND‑filing | • The program is in the IND‑enabling phase; toxicology and GLP‑compliant manufacturing data are being compiled. • No human subjects have been dosed yet. |
• Anticipated IND submission in mid‑2026, paving the way for a Phase 1/2 trial in 2027. |
What the Call Will Cover
- Financial Results (Q2 2025) – The company will release its second‑quarter earnings, providing insight into cash‑burn, R&D spend, and runway for the clinical programs.
- Corporate Update – Management will discuss strategic initiatives, partnership activities, and the broader commercialization roadmap for MSC‑NT.
- Trial Updates – Specific updates on the RESCUE‑ALS pivotal trial (enrollment progress, safety signals, and timeline for the primary efficacy read‑out) and the Phase 2 Parkinson’s study (mid‑trial enrollment status, safety data, and next‑step planning) will be provided.
- No new efficacy data were announced in the press release; the focus is on patient‑dosing milestones and regulatory timelines.
- Future Milestones – Anticipated regulatory filings (BLA for ALS, IND for retinal) and potential expansion of the Parkinson’s program based on interim safety data.
Bottom‑Line Take‑aways
- Lead ALS program (RESCUE‑ALS) is well‑underway, with ~ 140 patients dosed and a Q4 2025 primary‑endpoint read‑out as the next major data point.
- Parkinson’s Phase 2 is progressing through the mid‑enrollment phase; safety data will be reviewed in early 2026 before any decision on a larger trial.
- Retinal‑degeneration work is still in the IND‑pre‑clinical stage, with an IND filing expected mid‑2026.
The upcoming conference call will therefore serve as the primary venue for the company to communicate the current status of these lead clinical programs, confirm that enrollment targets are on track, and outline the anticipated timelines for key data read‑outs and regulatory submissions. Investors and analysts can expect a clear picture of where BrainStorm stands in terms of clinical progress, as well as an update on the financial resources that will support the continuation of these programs.