LEXINGTON, Mass., May 4, 2017 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of
immune checkpoint antibodies and cancer vaccines, provided a
corporate update and reported financial results for the first
quarter ended March 31, 2017.
"In the first quarter we amended our agreement with Incyte and
streamlined and optimized our R&D operations; our balance sheet
has been strengthened and our projected burn reduced. Importantly,
these steps allow us to focus on clinical programs that support our
path to commercialization. In the forefront are our antibodies
targeting CTLA-4 and PD-1," said Garo H.
Armen, Ph.D., Chairman and CEO of Agenus.
"These initiatives also provide us with the ability to advance
our other assets on an accelerated path, including our innovative
programs which include next generation immune targets, such as
TIGIT and 4-1BB, our neoantigen vaccine, AutoSynVax™
and our cell therapy programs which we anticipate will be advanced
through an externally funded subsidiary."
Cell Therapy Program
Agenus unveils previously
undisclosed I-O cell therapy discovery program. This program has
been advanced over the last 18 months, including the identification
of at least one potential development candidate. The Company
plans to pursue its cell therapy assets with the formation of a
separate business entity to be majority owned by Agenus and funded
externally.
Anticipated Clinical Milestones for H2 2017:
- AGEN1884 (anti-CTLA-4) Phase 1 trial: dose-escalation to be
completed with safety and pharmacodynamic data compiled; ASCO
poster presentation in June
- AGEN2034 (anti-PD-1) Phase1/2 trial:
-
- Dose-escalation with monotherapy and combination doses
- Patient recruitment in a second line cervical cancer
trial.
- AGEN1884+AGEN2034: commencement of a Phase 1b combination
trial, paving the way for a rapid path to registration
- AutoSynVax™ (neoantigen vaccine):
readouts for immunogenicity expected in patients with advanced
malignancies
Recent Highlights:
- Incyte agreement:
-
- Cash infusion of $80 million;
projected cost savings of $70M over
an 18-month time period
- Incyte responsible for fully funding GITR and OX40 clinical
programs
- Agenus eligible for royalties at 15%
- TIGIT reverted to Agenus
- Organizational streamlining:
-
- Basel, Switzerland site to
close-down later this year; key functions to transition to
Cambridge, UK.
- Patient enrollment commenced for Phase 1/2 clinical trial for
anti-PD-1 antagonist AGEN2034
- Initiated Phase 1 clinical trial for AutoSynVax™;
patient accrual complete
- QS-21 milestones:
-
- GSK's shingles vaccine containing Agenus' QS-21 filed for
regulatory approval in Japan in
addition to existing filings for US, Canada and EU
- Regulatory approvals anticipated in H2
- GSK's malaria vaccine containing QS-21 to be distributed in
select African countries as per WHO's recommendation.
- Identification of next generation anti-CTLA-4 antibody:
-
- Novel differentiated candidate targeting CTLA-4
- Manufacturing readiness:
-
- Agenus West successful GMP production of AGEN1884 at 1,000L
scale
First Quarter 2017 Financial Results
Cash, cash
equivalents and short-term investments were $124 million as of March
31, 2017 compared to $76
million as of December 31,
2016. For the first quarter ended March 31 2017, Agenus reported a net loss of
$17.1 million, or $0.18 per share, compared with a net loss for the
first quarter of 2016 of $31.8
million, or $0.37 per share.
The decrease in net loss for the three months ended March 31, 2017, compared to the net loss for the
same period in 2016, was primarily due to the accelerated milestone
payment received from Incyte. Our operating expenses
increased $6.1 million over the same
period in 2016 primarily due to the later stage advancement of our
programs.
Conference Call, Webcast and Prepared Statement
Information
Agenus executives will host a conference call on
Thursday, May 4, 2017 at 11:00 a.m. Eastern Time. To access the live call,
dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (international) and
ask to be joined into the Agenus call. The call will also be
webcast and will be accessible from the company's website at
www.agenusbio.com/webcast. A replay will be available on the
Company's website approximately two hours after the call and will
remain available for 90 days.
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 a number of 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 based 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.
Forward-Looking Statement
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' clinical
trial plans and activities, anticipated 2017 milestones, the
closing of the Company's Basel
site and related transfer to its UK site, updates on GSK's malaria
vaccine containing QS-21, and the Company's intentions around its
previously undisclosed cell therapy program. 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.
Michelle Linn, 781-674-4541
michelle.linn@agenusbio.com
Summary
Consolidated Financial Information
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations Data
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
$
26,956
|
|
$
5,959
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
32,640
|
|
25,038
|
|
General and
administrative
|
7,770
|
|
9,232
|
|
Non-cash contingent
consideration fair value adjustment
|
(196)
|
|
(342)
|
|
|
|
|
|
|
Operating
loss
|
(13,258)
|
|
(27,969)
|
|
|
|
|
|
|
Other expense,
net
|
(3,845)
|
|
(3,810)
|
|
|
|
|
|
|
Net loss
|
(17,103)
|
|
(31,779)
|
|
|
|
|
|
|
Dividends on Series
A-1 convertible preferred stock
|
(51)
|
|
(51)
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(17,154)
|
|
$
(31,830)
|
|
|
|
|
|
|
Per common share
data, basic and diluted:
|
|
|
|
|
Net loss attributable
to common stockholders
|
$
(0.18)
|
|
$
(0.37)
|
|
Weighted average
number of common shares outstanding, basic and diluted
|
93,508
|
|
86,687
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheet Data
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
March 31,
2017
|
|
December 31,
2016
|
|
Cash, cash
equivalents and short-term investments
|
$
123,824
|
|
$
76,437
|
|
Total
assets
|
203,269
|
|
156,986
|
|
Total stockholders'
equity (deficit)
|
8,905
|
|
(39,126)
|
|
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SOURCE Agenus Inc.