Humanigen Announces Abstracts Accepted for the British Thoracic Society Winter Meeting 2021

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced three abstracts pertaining to the potential use of lenzilumab in hospitalized COVID-19 patients will be presented at the British Thoracic Society Winter 2021 Meeting taking place Nov. 24-26, 2021. The society counts more than 4,000 members comprised of doctors, nurses, respiratory physiotherapists, scientists, and other professionals with a respiratory interest.

“We are pleased to have the opportunity to share the results of our Phase 3 study of lenzilumab in hospitalized COVID-19 patients with our medical and scientific colleagues in the United Kingdom,” said Cameron Durrant, MD, Chairman & CEO, Humanigen. “We believe the analysis of our LIVE-AIR data using baseline C-reactive protein (CRP) levels is important because it identifies a subset of patients, approximately 75% of the study population, for which lenzilumab treatment appears to show the greatest benefit. This is particularly relevant in the United Kingdom, where the government funded the formation of the International Severe Acute Respiratory Infection Consortium (ISARIC), a UK-wide consortium of doctors and scientists, that developed the 4C Mortality Score, which utilizes CRP levels as the only biomarker marker used to calculate the score. By focusing on patients most likely to benefit from treatment with lenzilumab, analysis shows the number needed to be treated to potentially prevent a death over a subsequent 28-day period may be reduced from 22.7 to 13.9.”

Lenzilumab is not authorized, or approved, in any country.

Abstract #S48
Lenzilumab Efficacy and Safety in Newly Hospitalized Covid-19 Subjects: Results from the LIVE-AIR Phase 3 Randomized Double-Blind Placebo-Controlled Trial

Summary: The abstract describes top-line results from Humanigen’s LIVE-AIR Phase 3 study, which reveal a 54% improvement (HR: 1.54; p=0.0403) in SWOV in lenzilumab-treated patients hospitalized with COVID-19 compared to those treated with standard of care plus placebo. The study also demonstrated significant improvement in SWOV for the predefined subgroup of subjects who received both corticosteroids and remdesivir (HR: 1.92; nominal p=0.0067). The incidence of treatment-emergent serious adverse events was similar across treatment groups. Treatment with lenzilumab resulted in no serious infusion-related reactions, no increase in the incidence of secondary infections and no attributable serious adverse events, including, hematologic or liver enzyme abnormalities. In addition, no cases of pulmonary alveolar proteinosis were reported.