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 provided a corporate and regulatory
update and reported financial results for the second quarter and
six months ended June 30, 2021.
Update on Status of Emergency Use Authorization (“EUA”)
Application
On May 28, 2021, Humanigen submitted an EUA application for
lenzilumab in patients hospitalized with COVID-19. Since that time,
the company has responded to several requests from the U.S. Food
and Drug Administration (“FDA”) regarding the application. No
formal timelines exist for the FDA to complete their review of our
EUA application and as a result the company is unable to give
guidance on the timing of a decision by the FDA.
“We remain firm in our belief the results of our LIVE-AIR Phase
3 study warrant lenzilumab being granted emergency use
authorization. The achievement of the primary endpoint for the
overall patient population, and the recent supplemental subset
analysis which showed significant response to treatment by Black
and African-American patients in the study, support our view of the
potential benefit lenzilumab could bring to patient care if
authorization were to be granted,” said Cameron Durrant, MD, Chief
Executive Officer, Humanigen.
Timothy Morris, CFO and COO, Humanigen, noted, “While the review
of the EUA application continues, we are preparing for potential
launch in the U.S., and simultaneously working to complete, before
the end of the third quarter 2021, the submission of the Marketing
Authorization Application (“MAA”) to the Medicines Healthcare
products Regulatory Agency (“MHRA”) in the U.K. We have initiated
the MAA process to the European Medicines Agency (“EMA”) and
anticipate the appointment of rapporteurs in the near term.”
Second Quarter and Recent Highlights:
Lenzilumab in hospitalized COVID-19
- Submitted an application to the FDA for an EUA for lenzilumab
for the treatment of patients hospitalized with COVID-19.
- Initiated filing and received acknowledgement the UK submission
for Marketing Authorization for lenzilumab in COVID-19 has been
accepted for expedited COVID-related rolling review by the MHRA.
The submission is expected to be completed by September 30,
2021.
- Initiated the process to make a submission to the European
Medicines Agency for Marketing Authorization of lenzilumab in
COVID-19.
- The company’s commercial partners in South Korea and the
Philippines, KPM Tech and Telcon RF Pharmaceutical, received
approval from South Korea’s Ministry of Food and Drug Safety, the
South Korean equivalent of FDA, to conduct a Phase 1 clinical study
of lenzilumab, to enable submission and potential approval in South
Korea.
- Announced analysis of results from our Phase 3 LIVE-AIR study
of lenzilumab in hospitalized patients with COVID-19 suggesting
Black and African-American patients having a CRP<150 mg/L may be
the highest responders to treatment, with a nearly 9-fold increase
in likelihood of survival without ventilation (“SWOV”) [n=51,
p-value=0.0418]. In the overall population with CRP<150 mg/L,
LIVE-AIR Phase 3 results show patients treated with lenzilumab
demonstrated a 2.5-fold increased likelihood of SWOV [mITT, n=351,
p-value=0.0009].
- Entered into manufacturing agreement with Chime Biologics to
produce lenzilumab bulk drug substance and drug product to be sold,
with requisite regulatory authorization, in regions outside the
United States.
Corporate
- Completed underwritten public offering of common stock, raising
net proceeds of $94.2 million.
- The company was added to the Russell 3000® Index in June
2021.
- Ken Trbovich was appointed to the newly-created role of SVP
Investor Relations.
ACTIV-5 Update
In August 2021, the National Institutes of Health (“NIH”)
announced the expansion of the Accelerating COVID-19 Therapeutic
Interventions and Vaccines (“ACTIV-5”) and Big Effect Trial, in the
“B” arm of the trial (“BET-B”), referred to as ACTIV-5/BET-B.
Following feedback from and consultation with the company, the NIH
advanced the study to a Phase 2/3 study with target enrollment of
at least 400 patients and amended the protocol for ACTIV-5/BET-B in
a manner that aligns with the design of the company’s LIVE-AIR
trial. As a result of the advancement to a Phase 2/3 and amended
protocol, the company anticipates that ACTIV-5/BET-B may serve as a
second confirmatory study required for submission to FDA as part of
a Biologics License Application (“BLA”) that the company would
submit if the ACTIV-5/BET-B data further validate the benefits of
lenzilumab in COVID-19 patients.
Second Quarter and Six Months Ended June 30, 2021 Financial
Results
Net loss for the three months ended June 30, 2021 was $70.8
million or $1.20 per share as compared to $24.0 million or $0.79
per share for the three months ended June 30, 2020. The net loss
for the six months ended June 30, 2021 was $136.4 million or $2.45
per share as compared to $26.5 million or $1.00 per share for the
six months ended June 30, 2020. The increase in net loss for both
periods was largely due to an increase in total expenses, mainly
Research and Development (“R&D”) expense which rose
significantly as the company accelerated its efforts to manufacture
lenzilumab for potential commercialization upon a regulatory
authorization. R&D expense increased $41.9 million from $21.1
million for the three months ended June 30, 2020, to $63.0 million
for the three months ended June 30, 2021, and increased $101.1
million from $21.8 million for the six months ended June 30, 2020,
to $122.9 million for the six months ended June 30, 2021. The
manufacturing expense included in R&D was $57.1 million for the
second quarter of 2021 as compared to $17.1 million for the prior
year quarter, and $107.1 million for the six months ended June 30,
2021, as compared to $17.4 million for the prior year period. The
costs incurred to produce lenzilumab will continue to be included
in R&D expense until lenzilumab is authorized or approved for
commercial use, at which point the amounts expended for production
would be reclassified as inventory. A meaningful portion of these
expenses are associated with initiation of manufacturing processes
on a site-by-site basis.
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet
changes, was $103.8 million for the six months ended June 30, 2021.
During the same period, the company raised net proceeds of $36.1
million from the sale of shares of common stock under its
At-the-Market offering program, drew the first tranche of $25.0
million under its credit facility with Hercules Capital, providing
net proceeds of $24.4 million, and completed a public offering of
common stock with net proceeds of $94.2 million. As of June 30,
2021, the company had cash and cash equivalents of $120.5 million.
The company expects to continue to use its funds on the
manufacturing of lenzilumab in anticipation of its potential
commercialization under EUA in the US or conditional marketing
authorization in the UK. For the third quarter of 2021 the company
anticipates the R&D expense related to lenzilumab production
will be same level as the second quarter of 2021. If an EUA or CMA
for lenzilumab is not received in the third quarter of 2021, the
company would seek to decrease its spending on lenzilumab
production.
A summary of key financial highlights as of and for the three
and six months ended June 30, 2021 and 2020 is as follows ($ in
thousands):
Three Months Ended June 30, Six Months Ended June 30,
2021
2020
2021
2020
License revenue $
1,036
$
-
$
1,522
$
-
Research and development
63,012
21,143
122,946
21,802
General and administrative
8,076
1,956
13,024
3,354
Loss from operations
(70,052
)
(23,099
)
(134,448
)
(25,156
)
Net loss $
(70,803
)
$
(24,022
)
$
(136,370
)
$
(26,489
)
Net loss per common share $
(1.20
)
$
(0.79
)
$
(2.45
)
$
(1.00
)
Weighted average common shares
58,843,567
30,222,568
55,735,008
26,538,337
June 30, 2021 December 31, 2020 Cash and cash
equivalents $
120,536
$
67,737
Current assets $
121,640
$
68,212
Current liabilities
50,314
20,415
Working Capital $
71,326
$
47,797
About Humanigen, Inc.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’. Lenzilumab is a
first-in class antibody that binds to and neutralizes
granulocyte-macrophage colony-stimulating factor (GM-CSF). Results
of preclinical models indicate GM-CSF is an upstream regulator of
many inflammatory cytokines and chemokines involved in the cytokine
storm. Early in the COVID-19 pandemic, investigation showed high
levels of GM-CSF secreting T cells were associated with disease
severity and intensive care unit admission. Humanigen’s Phase 3
LIVE-AIR study suggests early intervention with lenzilumab may
prevent consequences of a full-blown cytokine storm in hospitalized
patients with COVID-19. Humanigen is developing lenzilumab as a
treatment for cytokine storm associated with CD19-targeted CAR-T
cell therapies and exploring the effectiveness of lenzilumab in
other inflammatory conditions such as acute Graft versus Host
Disease (aGvHD) in patients undergoing allogeneic hematopoietic
stem cell transplantation (HSCT), eosinophilic asthma, and
rheumatoid arthritis. Humanigen is also developing a portfolio of
clinical and pre-clinical therapies for the treatment of
inflammation and immuno-oncology. For more information, visit
www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and
Facebook.
Forward-Looking Statements
All statements other than statements of historical facts
contained in this press release are forward-looking statements.
Forward-looking statements reflect management's current knowledge,
assumptions, judgment, and expectations regarding future
performance or events. Although management believes that the
expectations reflected in such statements are reasonable, they give
no assurance that such expectations will prove to be correct, and
you should be aware that actual events or results may differ
materially from those contained in the forward-looking statements.
Words such as "will," "expect," "intend," "plan," "potential,"
"possible," "goals," "accelerate," "continue," and similar
expressions identify forward-looking statements, including, without
limitation, statements regarding Humanigen’s beliefs as to the
potential benefits of lenzilumab in COVID-19 patients; the timing
for submission of applications for MAA in the U.K. and EU; the
potential that the company will receive EUA or other marketing
approval outside the United States for lenzilumab, which is not
assured; the potential that ACTIV-5/BET-B may serve as a
confirmatory study to support a future BLA in the US or augment
other regulatory applications; our anticipated spending to prepare
to commercialize lenzilumab in the U.S. and other markets, if EUA
or other marketing approval were granted; and statements regarding
Humanigen’s beliefs relating to the technologies in Humanigen’s
current pipeline.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to, the risks inherent in
the company’s lack of profitability and potential need for
additional capital to grow its business; its ability to
successfully commercialize lenzilumab under an EUA or other
conditional marketing authorizations, if granted; its dependence on
partners to further the development of its product candidates; the
uncertainties inherent in the development, attainment of the
requisite regulatory authorizations and approvals and launch of any
new pharmaceutical product; the outcome of pending or future
litigation; and the various risks and uncertainties described in
the "Risk Factors" sections and elsewhere in Humanigen's periodic
and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You should not rely upon any
forward-looking statements as predictions of future events. The
Company undertakes no obligation to revise or update any
forward-looking statements made in this press release to reflect
events or circumstances after the date hereof or to reflect new
information or the occurrence of unanticipated events, except as
required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210812005787/en/
Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563
Humanigen Investor Relations Ken Trbovich Humanigen
trbo@humanigen.com 650-410-3206
Humanigen (NASDAQ:HGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Humanigen (NASDAQ:HGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024