HGEN - Bull Thesis

BULL THESIS

• HGEN overall corporate and executive summary

  • Multiple upcoming Phase 3 trials for 2022

  • Lenzi appears to be an active and safe anti-GM-CSF antibody therapeutic with human clinical proof of concept data

• Lenzilumab

  • COVID-19

    • Grouped among most promising COVID-19 therapies in EU and by NIH

    • Phase 3 COVID trial in May 2020 and additional data in June 2020 caused stock to rise almost 400% over 1 month

    • UK rolling submission accepted in July 2021 and apparently still pending

    • Expect to submit BLA in US in 2022 if positive ACTIV-5/BET-B results

    • ACTIV-5/BET-B data expected by end Q1 or early Q2 2022

      • Could be included in an amended Emergency Use Authorization submission if trial is successful

    • LIVE-AIR Phase 3 trial showed good efficacy in sub-population

      • Subgroup patients with baseline CRP<150 mg/L who received lenzilumab had a more than 2.5-fold higher likelihood to survive without IMV than patients who received placebo (p<0.001)

      • Published in a leading journal: LANCET

  • Numerous opportunities for Lenzi outside Covid 19

    • RR DLBCL

      • ZUMA-19 (completed 1b trial and no safety issues)

        • Reported data in April 2021

        • At recommended Phase 2 dose, lenzilumab + CAR-T demonstrated 100% ORR and no severe cytokine release syndrome or severe neurotoxicity

    • GvHD

      • Partnership w/ IMPACT and University of Zurich

      • RATinG Phase ⅔ trial, first patient to be dosed in H1 2022

    • NHL

      • Anticipating Phase 3 trial enrollment in H1 2022

      • Lenzilumab could be used to improve safety and efficacy of CD19 CAR-T therapies

    • CMML

      • PREACH-M Phase ⅔ trial, first patient dosed Oct 2021 and primary endpoint of 12 month CR and PR

• Ifabotuzumab

  • GBM

    • Completed Phase 1 trial and planning Phase 1b trial in early 2022

FS/MV 3/4/22

See our updated bull, bear, Amp View forum post HERE after becoming a subscriber. Learn more here.