HGEN - Bull Thesis
(Updated 4/1/22)
BULL THESIS SUMMARY
HGEN overall corporate and executive summary
ACTIV-5/BET-B data expected by end Q1 or early Q2 2022
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
FS/MV 3/4/22 (4/1/22 updated)
(See below for full bull/bear analysis)
BULL THESIS
HGEN overall corporate and executive summary
ACTIV-5/BET-B data expected by end Q1 or early Q2 2022
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 (4/1/22 updated)
See the bull/bear analysis in our BPIQ Pro Forum post here and the full bull/bear analysis w/ Amp view in our Amp Premium Forum post here. To become a subscriber Learn more here.
#HGEN #Lenzilumab #Ifabotuzumab