LEXINGTON, Mass., March 15, 2018 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with a pipeline of
immune checkpoint antibodies and cancer vaccines, provided a
corporate update and reported financial results for fourth quarter
and full year 2017.
"Innovation and speed are key drivers of success in I-O. With
our current capabilities and our extensive portfolio of novel I-O
approaches, we have positioned Agenus to develop combination
treatments for more patients and more cancers. Our ability to
rapidly advance clinical trials with our CTLA-4 (AGEN1884) and
Keytruda as well as trials using our own proprietary combinations
with AGEN1884 and PD-1 (AGEN2034) could lead to our BLA filing as
soon as the end of 2019. We recently produced commercial grade
CTLA-4 to assure our commercial readiness," said Garo H. Armen, Ph.D., Chairman and CEO of
Agenus. "This year, we will also file several INDs for our novel
I-O antibodies including first/best-in-class bispecific tumor
microenvironment conditioning agents."
Milestones Achieved:
- Clinical Trials
-
- Launched phase 2 trial with the combination of AGEN1884 with
Keytruda in patients with 1L NSCLC and over 50% PD-L1
expression
- Completed dose escalation trials for AGEN1884 (anti-CTLA-4) and
AGEN2034 (anti-PD-1)
- Launched a phase 2 trial with the combination of our
proprietary CTLA-4 (AGEN1884) and PD-1 (AGEN2034), identified
optimal dose, and expanded trial into relapsed/refractory cervical
cancer
- Reported initial safety and immunogenicity of our neoantigen
vaccine AutoSynVax; combination trials with our checkpoint
antibodies are planned.
- Pipeline - first and/or best-in-class monospecific and
bispecific antibodies
-
- Developed our novel next generation CTLA-4 – IND filing
expected in 2018.
- Developed molecules and initiated IND preparations for our
first/best in class bispecific antibodies designed to condition the
tumor microenvironment through regulatory T cell depletion and
other undisclosed mechanisms; IND filings expected in 2018
- Launched AgenTus Therapeutics, our cell therapy
subsidiary
-
- Appointed Bruno Lucidi as CEO of
AgenTus, advanced our pipeline including our proprietary allogeneic
format and our proprietary phosphorylated targets.
- Completed non-dilutive financial transaction
-
- Completed a $230 million
non-dilutive royalty transaction with HealthCare Royalty Partners
on sales of GlaxoSmithKline's QS-21 containing vaccines and
eliminated liabilities associated with Oberland notes. Net proceeds
to Agenus from this transaction were approximately $28 million.
2018 MILESTONES
- Efficacy data for AGEN 1884 plus Keytruda in 1L NSCLC and
planning for BLA filing
- Efficacy data from AGEN1884 (anti-CTLA-4) and AGEN2034
(anti-PD-1) trials
- Formalize regulatory engagements for the above combos for BLA
filing
- IND filing for next generation CTLA-4 and two undisclosed
bispecific antibodies
- Start combination trial with our CTLA-4 and PD1 with AGEN
neoantigen vaccine AutoSynVax™
- Complete IND enabling studies for AgenTus Therapeutics lead
adoptive cell therapy program
Update on GMP manufacturing
- Expanded and upgraded antibody manufacturing capabilities
- Produced GMP grade CTLA-4 and PD1 antibodies for our clinical
trials and acquired commercial grade AGEN1884 (anti-CTLA-4) and
expecting commercial grade AGEN2034 (anti-PD-1) by mid-year.
Fourth Quarter and Full Year 2017 Financial Results
Cash, and cash equivalents were $60.2
million at December 31, 2017.
Subsequent to the end of the year, Agenus received net proceeds of
approximately $28.1 million from our
royalty bond restructuring.
For the fourth quarter, Agenus' cash used in operating
activities was approximately $25.8
million compared to approximately $26.2 million during the third quarter while our
reported net loss for the quarter was $35.0
million or $0.35 per share,
compared with a net loss for the fourth quarter of 2016 of
$26.1 million, or $0.30 per share.
Cash used in operating activities for the year ended
December 31, 2017 was $94.2 million compared to $80.0 million for the year ended 2016. The
Company incurred a net loss of $120.7
million or $1.23 per share,
for the year ended December 31, 2017
compared with a net loss of $127.0
million, or $1.46 per share,
in the same period in 2016.
Summary
Consolidated Financial Information
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Condensed
Consolidated Statements of Operations Data
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(in thousands, except
per share data)
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(unaudited)
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Three months ended
December 31,
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Year ended December
31,
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2017
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2016
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2017
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2016
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Revenue
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$
8,354
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$
5,576
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$
42,877
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$
22,573
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Operating
expenses:
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Research and
development
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31,872
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25,983
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|
116,125
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|
94,971
|
General and
administrative
|
9,784
|
|
8,670
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|
33,741
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33,126
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Non-cash contingent
consideration fair value adjustment
|
(3,310)
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(9,401)
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(3,188)
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1,953
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Operating
loss
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(29,992)
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(19,676)
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(103,801)
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(107,477)
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Other expense,
net
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(5,043)
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(6,447)
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(16,891)
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(19,518)
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Net loss
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(35,035)
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(26,123)
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(120,692)
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(126,995)
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Dividends on Series A
convertible preferred stock
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(52)
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(51)
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(206)
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(204)
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Net loss attributable
to common stockholders
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$
(35,087)
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$
(26,174)
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$
(120,898)
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$
(127,199)
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Per common share
data, basic and diluted:
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Net loss attributable
to common stockholders
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$
(0.35)
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$
(0.30)
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$
(1.23)
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$
(1.46)
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Weighted average
number of common shares outstanding, basic and diluted
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100,961
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|
87,416
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|
98,415
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|
87,070
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Condensed
Consolidated Balance Sheet Data
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(in
thousands)
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(unaudited)
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December 31,
2017
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December 31,
2016
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Cash, cash
equivalents and short-term investments
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$
60,187
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$
76,437
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Total
assets
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138,402
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156,986
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Total stockholders'
deficit
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(75,816)
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(39,126)
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About Agenus
Agenus is a clinical-stage immuno-oncology company focused on
the discovery and development of therapies that engage the body's
immune system to fight cancer. The Company's vision is to expand
the patient populations benefiting from cancer immunotherapy by
pursuing combination approaches that leverage a broad repertoire of
antibody therapeutics and proprietary cancer vaccine platforms. The
Company is equipped with a suite of antibody discovery platforms
and a state-of-the-art GMP manufacturing facility with the capacity
to support early phase clinical programs. Agenus is headquartered
in Lexington, MA. For more information, please
visit www.agenusbio.com; information that may be important to
investors will be routinely posted on our website.
About AgenTus Therapeutics, Inc.
AgenTus
Therapeutics is a preclinical-stage biopharmaceutical company that
will focus on the discovery, development, and commercialization of
breakthrough "living drugs" to advance potential cures for cancer
patients. AgenTus will employ naturally-derived and
engineered receptors, specifically T cell receptors (TCRs) and
Chimeric Antigen Receptors (CARs), designed to supercharge human
immune effector cells to seek and destroy cancer. AgenTus
will also aim to advance adoptive cell therapy formats which would
enable off-the-shelf living drugs. AgenTus will have
locations in Lexington, MA and Cambridge, UK. For
more information, please
visit www.agentustherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding Agenus' planned BLA
filing by the end of 2019 and 2018 milestones, including planned
IND filings, planned ASV combination trial and other clinical trial
plans and activities. These forward-looking statements are subject
to risks and uncertainties that could cause actual results to
differ materially. These risks and uncertainties include, among
others, the factors described under the Risk Factors section of our
most recent Quarterly Report on Form 10-Q or Annual Report on Form
10-K filed with the Securities and Exchange Commission. Agenus
cautions investors not to place considerable reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this press release, and
Agenus undertakes no obligation to update or revise
the statements, other than to the extent required by
law. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement.
Contact:
Agenus Inc.
Jennifer Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
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SOURCE Agenus Inc.