On March 10, 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, reported financial results for the year ending December 31, 2020 and announced objectives for 2021 (Press release, Humanigen, MAR 10, 2021, View Source [SID1234576424]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are proud of all the advances Humanigen made in 2020, not just as a company, but as a key player in the development of an effective treatment for hospitalized COVID-19 patients," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We were able to take lenzilumab from the context of preventing and treating cytokine storm in other therapeutic categories and adapt it at unprecedented speed to respond to the COVID-19 pandemic. We also succeeded in achieving our ambitious fundraising goals, culminating with our uplisting to Nasdaq, and expanded our leadership team with a number of critical hires. We look forward to reporting our progress on the ambitious goals we’ve set for 2021 and, if granted an EUA, provide a therapeutic option for hospitalized COVID-19 patients."
2020 Highlights Include:
Clinical Development – Lenzilumab for COVID-19
Lenzilumab’s clinical development program was augmented in 2020 with the filing of an Emergency IND and initiation of a Phase 3 study in hospitalized COVID-19 patients. The study fully enrolled 520 patients, with topline data anticipated to be released before the end of March 2021.
The results of the case-cohort study conducted by the Mayo Clinic were published in a peer-reviewed journal, showing that treatment with lenzilumab significantly reduced risk of mechanical ventilation or death and decreased length of hospital stay compared to patients treated with standard of care.
Lenzilumab was selected by NIH for inclusion in its fully funded and sponsored, 200-patient ACTIV-5/Big Effect Trial comparing lenzilumab and remdesivir to remdesivir alone.
In preparation for potential launch under EUA, Humanigen entered into several supply agreements with contract manufacturing organizations to supply bulk drug, fill/finish, and commercial packaging.
Clinical Development – CAR-T and Oncology
Lenzilumab was administered to the first patient in the ZUMA-19 study, a CAR-T clinical collaboration with Kite (a Gilead company).
A Phase 1 clinical trial of ifabotuzumab, Humanigen’s proprietary anti-EphA3 monoclonal antibody, in solid tumors completed enrollment.
Corporate
The company raised approximately $140 million in net proceeds in two equity financings, and its stock began trading on Nasdaq under the symbol "HGEN."
Humanigen executed a Cooperative Research and Development Agreement ("CRADA") with the Department of Defense ("DoD") and the Biomedical Advanced Research and Development Authority ("BARDA") for developing lenzilumab as a potential treatment for patients with COVID-19 in support of Operation Warp Speed.
Humanigen licensed development and commercial rights of lenzilumab for South Korea and the Philippines to KPM Tech/Telcon.
The company augmented its intellectual property portfolio, securing its first patent for the use of lenzilumab in CAR-T cell therapy.
The company expanded the leadership team with experienced executives, including Dr. Dale Chappell, Chief Scientific Officer; Timothy Morris, Chief Operating Officer and Chief Financial Officer; Edward Jordan, Chief Commercial Officer; and Bob Atwill, Head of Asia-Pacific Region.
2021 Objectives Include:
Submit an EUA for lenzilumab as a treatment for hospitalized and hypoxic patients with COVID-19 pending positive results from the Phase 3 clinical trial.
Begin distribution of lenzilumab under the EUA, if granted.
Submit, for conditional approval, a Marketing Authorization Application ("MAA") for lenzilumab in COVID-19 to the European Medicines Agency for use in Europe.
Submit, for conditional approval, a MAA for lenzilumab in COVID-19 to the Medicines and Healthcare Products Regulatory Agency for use in the United Kingdom.
Submit a Biologics License Application ("BLA") for lenzilumab in COVID-19 to FDA.
Report results on the ongoing Phase 1b/2 ZUMA-19 CAR-T clinical trials with Kite (a Gilead company) and the completed Phase 1 study with ifabotuzumab.
Initiate studies of lenzilumab in acute Graft versus Host Disease ("GvHD") and chronic myelomonocytic leukemia ("CMML").
Secure partnerships to distribute lenzilumab in other regions outside the United States.
Year Ended December 31, 2020 Financial Results
Net loss for the year ended December 31, 2020 was $89.5 million or $2.42 per share as compared to $10.3 million or $0.46 per share for the year ended December 31, 2019. The increase in net loss for the year was largely due to an increase in Research and Development ("R&D") expense of $70.1 million from $2.6 million for the year ended December 31, 2019 to $72.7 million for the year ended December 31, 2020.
The increase in R&D expense is primarily due to increased clinical trial and clinical material manufacturing costs related to the COVID-19 lenzilumab Phase 3 clinical trial. The company expects development costs to decrease in 2021 as a result of the completion of the COVID-19 Phase 3 clinical trial and related manufacturing costs, which will be classified as Cost of Goods Sold if an EUA is granted.
The increase in the net loss for the year ended December 31, 2020 was also due to an increase in Selling, General and Administrative ("SG&A") expenses of $9.5 million from $6.3 million for the year ended December 31, 2019 to $15.8 million for the year ended December 31, 2020. The increase is primarily due to increased compensation costs, including stock-based compensation expense related to the hiring of functional heads in the third quarter of 2020, and an increase in commercial preparation activities as the company prepared for a potential launch of lenzilumab in 2021 under an EUA.
Three Months Ended December 31, 2020 Financial Results
Net loss for the three months ended December 31, 2020 was $32.3 million or $0.63 per share as compared to $2.0 million or $0.09 per share for the three months ended December 31, 2019. The increase in net loss for the period was largely due to an increase in R&D expense of $28.0 million from $0.5 million for the three months ended December 31, 2019 to $28.5 million for the three months ended December 31, 2020.
The increase in R&D expense is primarily due to increased clinical trial and clinical material manufacturing costs related to the COVID-19 Phase 3 clinical trial.
The increase in the net loss for the three months ended December 31, 2020 was also due to an increase in SG&A expenses of $2.9 million from $1.2 million for the three months ended December 31, 2019 to $4.1 million for the three months ended December 31, 2020. The increase in SG&A expense is primarily due to the items noted above for the year ended December 31, 2020.
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet changes, was $69.9 million for the year ended December 31, 2020. During 2020, the company raised $139.8 million in net proceeds from its private placement in June and its underwritten public offering in September 2020. As of December 31, 2020, the company had cash and cash equivalents of $67.7 million.