Humanigen, Inc (NASDAQ:HGEN) (FRA:0KB2) Wednesday announced that it has ended its third quarter with $91.4 million in cash and equivalents after raising around $72.7 million in a Nasdaq public offering and uplisting in September.
The company announced positive interim Phase 3 data recently on lenzilumab to treat patients hospitalized with COVID-19, with an estimated 37% more recoveries observed in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study versus current standard of care.
Humanigen CEO Cameron Durrant said in a statement: “We’ve achieved many important milestones in the third quarter, including completing a public offering to begin trading on Nasdaq, being selected for the National Institutes of Health’s ACTIV-5/Big Effect Trial, strengthening our management team, adding clinical trial sites in Brazil for our Phase 3 clinical trial of lenzilumab in patients with COVID-19, and expanding our manufacturing capacity with new agreements with Catalent and Thermo Fisher.”
He added: “For the last two months of 2020, we remain focused on enrollment of the Phase 3 trial of lenzilumab for patients hospitalized with COVID-19, in which we recently announced a positive analysis of interim Phase 3 data. As enrollment continues for this trial within the United States and in Brazil, we anticipate applying for an EUA in the first quarter of 2021. I’m pleased with how our team has remained dedicated to advancing promising therapeutics for cytokine storm and would like to thank the dedicated health care providers and essential workers who continue to expose themselves to risk during this pandemic.”
READ: Humanigen announces positive interim Phase 3 data on lenzilumab to treat patients hospitalized with COVID-19
During the 3Q, Humanigen executed a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in support of Operation Warp Speed (OWS) to support the development of lenzilumab as a potential treatment for patients with COVID-19.
Humanigen said it intends to file for EUA in the first quarter of 2021 either following interim data at 75% or at study completion. The Phase 3 trial evaluating patients hospitalized with COVID-19 is enrolling at sites across the US and Latin America. Current enrollment stands at 300 patients.
Timothy E. Morris, chief operating and financial officer of Humanigen added: “Our current cash balance is sufficient to complete the phase 3 trial and file the EUA. Now that we are part of Operation Warp Speed and following the announcement of the CRADA, we will explore the possibility of financial assistance from the US government to support development of lenzilumab.”
Contact Sean at [email protected]
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