Long-time PharmaCyte CEO Kenneth Waggoner has departed the biotech, leaving amid a cost freeze on all programs and an ongoing clinical hold on its “Cell-in-a-Box” technology.
Waggoner’s exit, which comes after nine years with the biotech, is effective immediately. In his absence, the board has tapped Joshua Silverman, a member of PharmaCyte’s board and former assistant press secretary to the president of the U.S., to lead as interim CEO.
The Las Vegas biotech has now been forced to think outside the box, forming a committee to “evaluate, investigate and review” PharmaCyte’s strategy, operations and risks. The committee’s main goal is to create shareholder value, Silverman said in an Oct. 7 release.
The biotech’s board has frozen all spending on PharmaCyte programs, including pre-clinical and clinical activities, until the review is complete and a plan of action is in place. Meanwhile, the company’s main technology, dubbed Cell-in-a-Box, remains under an FDA clinical hold.
In 2020, PharmaCyte submitted an application to the FDA to begin human trials for its live-cell encapsulation technology for the potential development of cell therapies to treat cancer, diabetes and malignant ascites. Instead, the agency slapped a hold on the application, telling PharmaCyte to conduct multiple additional preclinical studies first.
The FDA also requested additional information regarding data, manufacturing information and product release specifications. Specifically, the agency asked that PharmaCyte perform qualification studies for the drug substance-filling step.
Since the hold, PharmaCyte has been working with partner SG Austria to meet the FDA requirements.
“Inclusive to our concerns over the FDA clinical hold is the exploration of the current relationship with SG Austria and determining whether the interests of SG Austria and those of PharmaCyte are appropriately aligned in order to continue to pursue the development of this technology,” Silverman said.
PharmaCyte is currently considering other opportunities that could create new paths toward shareholder value, Silverman added.
The biotech’s stock appears unaffected by the CEO’s departure and review announcement, closing yesterday at $2.48 per share and rising slightly to $2.54 at 10:30 am E.T. today.