Business Context and Reporting Period
Company: Pluristem Therapeutics Inc. (PSTI)
Filing Type: Form 8-K (Current Report)
Date: May 14, 2020
Context: The registrant provided an update on the status of COVID-19 infected patients treated with its PLX cells under compassionate use programs in Israel and the FDA single patient Expanded Access Program in the U.S. All treated patients were in Intensive Care Units (ICU) on invasive mechanical ventilation suffering from Acute Respiratory Distress Syndrome (ARDS).
Key Financial Metrics
This filing is a Current Report (Item 8.01 Other Events) 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 Data
The filing reports preliminary clinical outcomes for patients treated with PLX cells as of May 14, 2020:
- Total Patients Treated: 18 (in Israel and the U.S.).
- Patients with 28-Day Follow-Up: 8 (1 in the U.S., 7 in Israel).
- Survival Rate (28 days): 87.5% of treated patients.
- Off Mechanical Ventilation (28 days): 75% of treated patients.
- Discharged Alive (28 days): 62.5% of treated patients.
- Comparative Data: The registrant compared its discharge rate to 3.3% (38 out of 1,151 patients) published for the NY area during March-April 2020 for patients requiring mechanical ventilation.
Guidance, Outlook, and Risks
Outlook and Next Steps:
- The company intends to provide a final update on compassionate use and Expanded Access programs upon completion.
- The registrant expects to treat its first patient in its Phase II clinical study in the U.S. for severe COVID-19 cases complicated by ARDS in the coming days.
Risks and Contingencies:
- Forward-looking statements are subject to uncertainties including delays in clinical trials, regulatory non-approval, and scientific difficulties.
- Historic results do not guarantee future conclusions; laboratory results may not translate to real surgical settings.
- Risks include patent insufficiency, product harm to recipients, and competition.
Investor Verification Checklist
- Verify the methodology and sample size of the comparative data (3.3% discharge rate) cited from the NY area.
- Confirm the enrollment timeline for the Phase II clinical study in the U.S.
- Monitor for the final update on the compassionate use and Expanded Access programs once completed.
- Review subsequent filings for any adverse events or changes in the clinical trial status.