LEXINGTON, Mass., May 9, 2019 /PRNewswire/ -- Agenus Inc. (NASDAQ:
AGEN), an immuno-oncology (I-O) company with a pipeline of immune
checkpoint antibodies, cancer vaccines and adoptive cell
therapies1, provided corporate updates and reported
financial results for the first quarter of 2019.
"2019 is off to a strong start. We have made significant
progress towards our efforts to bring transformative treatments to
cancer patients." said Garo H. Armen, Ph.D., Chairman and CEO
of Agenus. "In the first quarter of this year, we have strengthened
our balance sheet, accelerated enrollment in our BLA path trials,
and started a new clinical trial with our second generation
CTLA4."
- Achievements
-
- Strengthened balance sheet
-
- Closed on our collaboration with Gilead, which included
$120M upfront, $30M equity investment and up to $1.7B in potential additional fees and milestone
payments plus royalties
- Received $7.5 million from Gilead
as milestone payment for IND acceptance of AGEN1423 (now GS-1423),
by the FDA
- Enrollment in lead trials progressing; On track for
BLA in 2020
-
- Ongoing trials in cervical cancer are designed to support BLA
via accelerated pathway
- We plan to expand PD-1 development in additional indications
through novel funding mechanisms
- Enrollment proceeding in next-gen CTLA-4 trial
-
- Started first-in-human trial with our next-gen CTLA4.
- Enrollment advancing, and combinations and data expected this
year
- Advanced new discoveries, towards the clinic
-
- First-in-class bispecific licensed to Gilead, GS-1423 IND
accepted by the FDA
- On track to file an IND for a CD137 agonist and an off-the
shelf phosphorylated neoantigen vaccine
- QS-21 Updates
-
- Sales of Shingrix, containing our QS-21 Stimulon®,
continue to increase; GSK projects 2019 sales will exceed
$1.3Bn and pledged $100M investment to expand production of its
adjuvant system
- A large-scale trial with QS-21 containing Mosquirix®
vaccine against malaria, began in Africa
- AgenTus Cell Therapy Business:
-
- 2019 INDs are on track
- Partnership and private financing discussions are underway
First Quarter 2019 Financial Results
We ended the first quarter of 2019 with a cash balance of
$158 million as compared to
$53 million at December 31,
2018.
For the first quarter ended March 31,
2019, we reported net income of $17
million or $0.14 per share
compared to a net loss for same period in 2018 of $54 million, or $0.53 per share. In the first quarter we
recognized revenue of $80 million
which includes revenue from our transaction with Gilead and
non-cash royalties earned.
Conference Call, Webcast and Prepared Statement
Information
Date: Thursday, May 9, 2019
Time: 8:30 a.m. ET
Domestic Dial-in Number: (866) 682-6100
International Dial-in Number: (862) 298-0702
Conference ID: Agenus
Live Webcast: accessible from the Company's website
at http://investor.agenusbio.com/presentation-webcasts or
with this
link https://www.webcaster4.com/Webcast/Page/1556/30499
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 combination approaches that leverage a broad repertoire of
antibody therapeutics, proprietary cancer vaccine platforms, and
adoptive cell therapies (through its AgenTus Therapeutics
subsidiary). 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 and our
twitter handle @agenus_bio. Information that may be important to
investors will be routinely posted on our website and twitter.
About AgenTus Therapeutics, Inc.
AgenTus Therapeutics, a subsidiary of Agenus, is a
preclinical-stage biopharmaceutical company focused on the
discovery, development, and commercialization of breakthrough
"living drugs" to advance potential cures for cancer
patients. AgenTus employs 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 also aims
to advance adoptive cell therapy formats which would enable
off-the-shelf living drugs. AgenTus has 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 and AgenTus'
clinical development and regulatory plans and timelines, expected
timing for releasing clinical data, projected sales for GSK's
Shingrix vaccine, Agenus' plan to expand PD-1 development in
additional indications through novel funding mechanisms,
anticipated IND filings, and partnership and financing plans for
AgenTus. 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, as well as the Risk
Factors included in the Private Placement Offering Memorandum for
BEST. 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
1 Through AgenTus Therapeutics, a subsidiary of
Agenus
Select Financial
Information
|
(in thousands, except
per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
158,306
|
|
$
|
53,054
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Revenues, research
and development and other
|
$
|
71,286
|
|
$
|
1,636
|
Revenues, non-cash
royalty
|
|
|
8,605
|
|
-
|
Research and
development expenses
|
|
40,130
|
|
29,441
|
General,
administrative, and other expenses, net
|
10,150
|
|
8,004
|
Non-cash interest
expense
|
|
|
9,428
|
|
2,669
|
Non-cash contingent
consideration fair value adjustment
|
2,748
|
|
5,016
|
Loss on early
extinguishment of debt
|
|
-
|
|
10,767
|
Net income
(loss)
|
|
|
|
$
|
17,435
|
|
$
|
(54,261)
|
Net income (loss) per
share attributable to Agenus Inc. common stockholders:
|
|
|
|
Basic
|
|
|
|
|
$
|
0.14
|
|
$
|
(0.53)
|
Diluted
|
|
|
|
|
$
|
0.12
|
|
$
|
(0.53)
|
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SOURCE Agenus Inc.