Pluristem Therapeutics Stock (PSTI): Why The Price Fell Today

By Amit Chowdhry ● Dec 27, 2021
  • The stock price of Pluristem Therapeutics Inc. (NASDAQ: PSTI) fell by over 15% during intraday trading today. This is why it happened.

The stock price of Pluristem Therapeutics Inc. (NASDAQ: PSTI) fell by over 15% during intraday trading today. Investors are responding negatively to the company’s Phase II PLX-PAD cell studies in COVID-19 failing to meet the primary endpoint.

Pluristem Therapeutics had announced its topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. And the analysis is based on 89 patients enrolled in two Phase II studies in the U.S. (the “U.S. study”) and in Europe and Israel (EU study).

The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. And VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. 

The studies did not meet the primary efficacy endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, there were no differences in the safety profile were observed between PLX-PAD and placebo.

In July 2021, Pluristem had announced its decision to bring the studies to early clinical readout based on 89 patients enrolled, instead of the originally planned 180 patients (140 in the U.S. study and 40 in the EU study). And the decision came in response to COVID-19’s evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients. These changes in the evolution of COVID-19 raised a major concern about the potential variability in the patient population in the Studies. The early termination of recruitment led to a significant reduction in the statistical power of the Studies.

Efficacy trends from the studies included:

— A single administration of 300 million PLX-PAD cells demonstrated overall better results, compared to other treatment groups

— Patients in the U.S. study treated with a single dose of 300 million PLX-PAD cells (n=14) showed an increased survival rate by 40% at day 60 compared to placebo group (n=14) (50% vs. 35%)

— Patients in the EU Study treated with a single dose of 300 million PLX-PAD cells (n=11) showed an increased survival rate by 27% at day 60 compared to control group (n=12) (64% vs. 50%)

— In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 28 by 3.6 days, from 0.2 days in the control group (n=12) to 3.8 days in the treated group (n=11)

— In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 60 by 112% or 6.6 days, from 5.9 days in the control group (n=12) to 12.5 days in the treated group (n=11)

KEY QUOTE:

“Pluristem joined the global effort to fight the evolving and unexpected COVID-19 pandemic. We chose to focus on the most severe intubated patients suffering from ARDS associated with COVID-19, that have no viable treatment to date and are challenging healthcare systems worldwide. With the new coming wave of the Omicron variant, we intend to explore the opportunities based on the efficacy trends obtained from the Studies. I would like to thank everyone who has been involved in the Studies including the patients and their families, our investigators and study personnel, and the team at Pluristem for making extraordinary efforts to conduct these important studies during very challenging times.”

— Pluristem’s CEO and President Yaky Yanay

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.