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 reported financial results for the
first quarter ending March 31, 2021 and provided a regulatory
update on lenzilumab.
“We are encouraged by the achievements Humanigen has made since
the beginning of 2021 and by our progress on the emergency use
authorization application,” stated Cameron Durrant, MD, MBA, Chief
Executive Officer, Humanigen. “We successfully completed our Phase
3 study of lenzilumab, referred to as LIVE-AIR, for the
treatment of newly hospitalized and hypoxic COVID-19 patients.
Trial results showed that patients who received lenzilumab and
other treatments, including steroids and/or remdesivir, had a 54%
greater relative likelihood of survival without the need for IMV
compared with patients receiving placebo and other treatments. We
believe this statistically significant result, along with data
regarding additional endpoints and further analysis from the study,
support the submission of applications for emergency use
authorization to the U.S. Food and Drug Administration and
conditional marketing authorization in the United Kingdom and the
European Union. As is typical with COVID-19 study results, a
pre-print of the LIVE-AIR study was published on-line. Positive
results from the Phase 1b study of lenzilumab in combination with
CAR-T gave further encouragement to our therapeutic approach to
breaking the linkage between efficacy and toxicity in CAR-T, and we
are designing a Phase 2 study of lenzilumab combined with all
commercially available CD19 CAR-T therapies in diffuse large B-cell
lymphoma patients.”
Highlights from the First Quarter of 2021 Include:
Clinical – Lenzilumab in COVID-19
- The Phase 3 results from the LIVE-AIR study were announced,
demonstrating that lenzilumab improves survival without the need
for mechanical ventilation in hospitalized, hypoxic patients with
COVID-19.
- Results from the LIVE-AIR Phase 3 study were published in
MedRxiv,
(https://www.medrxiv.org/content/10.1101/2021.05.01.21256470v1.full.pdf)
showing additional analysis from the trial, including patients
treated with remdesivir and/or steroids, and a second analysis
which showed patients under 85 years of age with C-reactive protein
(“CRP”), a widely-utilized inflammatory marker, less than 150 mg/L,
derived the greatest benefit of treatment with lenzilumab.
- With the report of positive top-line results from the LIVE-AIR
study in March 2021, the company met the first of two specified
milestones under the South Korea license agreement with KPM Tech
Co., Ltd. and its affiliate, Telcon RF Pharmaceutical, Inc., and
received $6.0 million (or $4.5 million net of withholding taxes and
other fees and royalties) in the second quarter of 2021.
- In preparation for potential launch under emergency use
authorization (“EUA”) and conditional marketing authorization
(“CMA”), Humanigen entered into several supply agreements with
contract manufacturing organizations (“CMOs”) to supply bulk drug,
fill/finish, and commercial packaging.
Clinical – CAR-T and Oncology
- The positive data from the Phase 1 study of ifabotuzumab in
glioblastoma multiforme was presented at the AACR Annual Meeting
2021.
- The CAR-T Phase 1b study results in diffuse large B-cell
lymphoma(“DLBCL”) with lenzilumab were announced, showing 100%
Objective Response Rate (“ORR”) and no severe cytokine release
syndrome or severe neurotoxicity at the recommended dose.
- With the positive Phase 1b results, the company terminated its
clinical collaboration agreement with Kite, a Gilead Company, and
announced plans to initiate a Phase 2 study with all commercially
available CD19 CAR-T therapies for DLBCL patients.
Corporate
- Dr. Adrian Kilcoyne was appointed to the newly created role of
Chief Medical Officer.
- Entered into a loan facility with Hercules Capital which will
provide the company up to $80 million of secured debt
financing.
- The company launched a public offering of common stock which
closed after quarter-end, resulting in net proceeds to Humanigen of
$94.1 million.
- Two patents were issued for the use of lenzilumab, expanding
the company’s anti-GM-CSF patent portfolio.
Lenzilumab Regulatory Update
The company recently held a meeting with FDA to discuss the
filing of an EUA for lenzilumab for hospitalized, hypoxic COVID-19
patients, where topline data from the LIVE-AIR study were reviewed,
along with the timeline for submission of additional clinical and
manufacturing data for lenzilumab. The company plans to submit an
EUA application at the end of May 2021. The company has also been
in discussion with the Medicines and Healthcare Products Regulatory
Agency (“MHRA”) for the use of lenzilumab in COVID-19 patients in
the United Kingdom and plans to initiate a rolling CMA submission
before the end of the second quarter of 2021. The company also
plans to submit for CMA to the European Medicines Agency (“EMA”)
for the use of lenzilumab in the European Union. Further, the
company is reviewing the possibility of similar submissions for
approval or compassionate use in other territories or countries
worldwide.
The company intends to submit a Biologics License Application
(“BLA”) to FDA in 2022, for the use of lenzilumab in hospitalized,
hypoxic COVID-19 patients. Since BLAs typically require more than
one study, the company is currently evaluating the extent to which
ACTIV-5/BET-B may serve as a basis for a BLA-confirmatory study for
lenzilumab.
First Quarter Ended March 31, 2021 Financial Results
Net loss for the three months ended March 31, 2021 was $65.6
million or $1.25 per share as compared to $2.5 million or $0.11 per
share for the three months ended March 31, 2020. The increase in
net loss for the first quarter 2021 as compared to the first
quarter 2020 was largely due to an increase in total expenses,
mainly Research and Development expense (“R&D”) of $59.2
million from $0.7 million for the three months ended March 31, 2020
to $59.9 million for the three months ended March 31, 2021. The
increase in R&D is primarily due to an increase of $51.4
million of expense in lenzilumab manufacturing costs and $7.5
million for clinical trial expenses related to the LIVE-AIR study,
both of which began after the first quarter of 2020. The costs
incurred for the production of lenzilumab will continue to be
included in R&D until lenzilumab is authorized or approved for
commercial use, at which point the amounts expended for production
will be classified as inventory.
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet
changes, was $35.8 million for the three months ended March 31,
2021. During the three months ended March 31, 2021, the company
raised net proceeds of $36.1 million from the sale of shares of
common stock under its At-the-Market offering program. The company
drew the first tranche of $25.0 million under its credit facility
with Hercules Capital, providing net proceeds of $24.4 million. As
of March 31, 2021, the company had cash and cash equivalents of
$92.9 million. The company also completed a public offering in the
second quarter of 2021 with net proceeds of $94.1 million. The
proforma balance of cash and cash equivalents at March 31, 2021
with the proceeds from the public offering is $187.0 million. The
company expects to continue to use its funds on development and
manufacturing of lenzilumab in anticipation of its potential
commercialization under EUA or other conditional marketing
authorizations. In the second quarter of 2021 the company
anticipates the amount of spending on lenzilumab production will be
at least the same level as the first quarter of 2021. If an EUA or
CMA for lenzilumab is not received by mid-2021, the company will
seek to decrease or eliminate spending on the production of
lenzilumab for commercial use.
A summary of key financial highlights as of and for the three
months ended March 31, 2021 and 2020 is as follows ($ in
thousands):
Three Months Ended March 31,
2021
2020
License revenue $
486
$
-
Research and development
59,934
659
General and administrative
4,948
1,398
Loss from operations
(64,396
)
(2,057
)
Net loss $
(65,567
)
$
(2,467
)
Net loss per common share $
(1.25
)
$
(0.11
)
Weighted average common shares
52,655,756
22,854,106
March 31, 2021 December 31, 2020 Cash and cash
equivalents $
92,892
$
67,737
Current assets $
98,758
$
68,212
Current liabilities
53,255
20,415
Working Capital $
45,503
$
47,797
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and
pre-clinical therapies for the treatment of cancers and infectious
diseases via its novel, cutting-edge GM-CSF neutralization and
gene-knockout platforms. Humanigen’s immediate focus is on the
development of lenzilumab as a therapy for hospitalized, hypoxic
COVID-19 patients. Humanigen recently announced plans to initiate a
randomized, multicenter, potentially registrational, Phase 2 study
to evaluate the efficacy and safety of lenzilumab combined with all
commercially available CD19 CAR-T therapies in diffuse large B-cell
lymphoma.
Humanigen is also focused on creating next-generation
combinatory gene-edited CAR-T therapies using strategies to improve
efficacy while employing GM-CSF gene knockout technologies to
control toxicity. In addition, Humanigen is developing its own
portfolio of proprietary first-in-class EphA3-CAR-T for various
solid cancers and EMR1-CAR-T for various eosinophilic disorders.
Humanigen is also exploring the effectiveness of its GM-CSF
neutralization technologies (either through the use of lenzilumab
as a neutralizing antibody or through GM-CSF gene knockout) in
combination with other CAR-T, bispecific or natural killer (NK) T
cell engaging immunotherapy treatments to break the
efficacy/toxicity linkage, including to prevent and/or treat
graft-versus-host disease (GvHD) in patients undergoing allogeneic
hematopoietic stem cell transplantation (HSCT). 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 the timing for submission of
applications for EUA and BLA, and for conditional marketing
authorization in the UK and EU, as well as 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 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 presentation to reflect
events or circumstances after the date hereof, to reflect new
information or the occurrence of unanticipated events, to update
the reasons why actual results could differ materially from those
anticipated in the forward-looking statements, in each case, except
as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210513005967/en/
Humanigen Media Grace Catlett RXMD Gcatlett@rxmedyn.com
516-318-8563
Humanigen Investors Alan Lada Solebury Trout
ALada@SoleburyTrout.com 617-221-8006
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