BARDA rejects Pluristem's request for radiation study funding

Shares in Pluristem fell 11% in premarket trading following news the U.S. Biomedical Advanced Research and Development Authority rejected its request for funding. (NRCgov/CC BY 2.0)

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has rejected Pluristem Therapeutics’ request for funding to conduct a study. Pluristem wanted the money to show its cell therapy PLX-R18 is better than standard of care at treating acute radiation syndrome (ARS).

Israel’s Pluristem advanced its placenta-derived allogeneic cell therapy PLX-R18 with the support of the National Institutes of Health. Pluristem said the studies linked the cell therapy to statistically significant improvements in the rate of survival and recovery of blood cell production in irradiated animals, encouraging it to seek to put the ARS treatment through further tests.

However, Pluristem will have to take the asset forward without the support of BARDA. Pluristem disclosed the setback in a statement that revealed “BARDA has chosen not to move forward with the funding of the current proposal” at this time.

According to Pluristem, BARDA knocked back the request for funding based on “technical considerations as determined by a Technical Evaluation Panel” along with its current funding and strategic needs and its aim to “balance” its current portfolio. 

Pluristem CEO Yaky Yanay brushed off the setback, pointing to existing ARS collaborations to show the company can continue to take PLX-R18 forward in the absence of support from BARDA. 

“While we had hoped to receive the funding of the proposal, we understand that at this time there are a set of parameters that led BARDA to this decision. We will continue to advance our current ARS projects with the U.S. National Institute of Allergy and Infectious Diseases, U.S. Department of Defense, Fukushima Hospital and the University in Japan and pursue additional opportunities and collaborations in this area,” Yanay said in a statement.

Investors took a more downbeat view of the situation. Shares in Pluristem fell 11% in premarket trading following the news. With $19.2 million in current assets as of the end of 2019, $7.3 million of which was in cash and equivalents, Pluristem was looking to BARDA funding to enable it to take the cell therapy forward without using up its internal resources.