Full Press Release Details
Reports First Quarter 2016 Financial Results and Operational Progress
to host conference call at 11am ET today
LEXINGTON, Mass.--(BUSINESS WIRE)--April 28, 2016--Agenus Inc.
(NASDAQ:AGEN), an immuno-oncology company developing checkpoint
antibodies and cancer vaccines, today provided a corporate update and
reported financial results for the first quarter ended March 31, 2016.
"In the first quarter we advanced our checkpoint antibodies by gaining
FDA clearance for the Investigational New Drug applications for our
CTLA-4 antagonist antibody AGEN1884, and for our GITR agonist antibody
partnered with Incyte, INCAGN1876," said Garo H. Armen, Ph.D., Chairman
and CEO of Agenus. "Earlier this week, we commenced a Phase 1 trial of
AGEN1884 in solid tumors with the first patient in the trial having been
dosed. During the remainder of 2016, we expect to begin clinical trials
for additional checkpoint antibody candidates. Our plans this year and
into next include initiating one or more randomized trials with
Prophage , including combination trials with approved and/or
experimental immunotherapeutic agents. Within the next 12 months we also
plan to initiate a Phase 1 trial of our AutoSynVax or ASV vaccine, a
synthetic autologous vaccine candidate that targets cancer neoantigens.
Finally, we expect to consummate non-dilutive funding strategies and
evaluate additional strategic alliances and partnerships to strengthen
our immuno-oncology capabilities."
First Quarter 2016 and Recent Corporate Highlights
April: Initiated Phase 1 trial of AGEN1884, a CTLA-4 antagonist
antibody, in solid tumors. AGEN1884 is the first of a series of
checkpoint antibodies the Company is developing. AGEN1884 was
developed using Agenus' powerful in-house antibody technology platform.
April: Presented preclinical data for three checkpoint antibody
programs at the American Association for Cancer Research (AACR)
conference: INCAGN1949 (an OX40 agonist antibody, partnered on
a 50/50 financial basis with Incyte), INCAGN1876 (an agonist antibody
for the glucocorticoid-induced TNFR-related protein, or GITR, also
partnered on a 50/50 basis with Incyte), and our anti-CTLA-4 program
(AGEN1884 and AGEN2041, partnered with Recepta for certain South
American territories). The poster presentations covered preclinical
pharmacology for each antibody, including detailed studies to support
potential in vivo mechanism(s) of action. Data from the
INCAGN1949 and INCAGN1876 programs will also be presented at the
upcoming Protein and Antibody Engineering Summit (PEGS) in Boston
January: Investigational New Drug applications received
clearance from the U.S. Food and Drug Administration for two
checkpoint antibodies: AGEN1884 (CTLA-4 antagonist) and INCAGN1876
(GITR agonist partnered with Incyte).
January: Began integration efforts for our antibody manufacturing
facility acquired from Xoma in December 2015. The facility will
enable the Company to manufacture checkpoint antibodies for its own
programs and those of its collaborators. The facility is expected to
provide Agenus' antibody supply requirements for most programs through
clinical proof-of-concept studies.
First Quarter 2016 Financial Results
For the first quarter ended March 31 2016, Agenus reported a net loss
attributable to common stockholders of $31.8 million, or $0.37 per
share, basic and diluted, including $9.6 million in non-cash expenses.
This compares to a net loss attributable to common stockholders for the
first quarter of 2015 of $18.8 million, or $0.28 per share, basic and
diluted. The increase in net loss attributable to common stockholders
for the three months ended March 31, 2016, compared to the net loss
attributable to common stockholders for the same period in 2015, was
primarily due to the advancement of our checkpoint programs.
Cash, cash equivalents and short-term investments were $148.2 million as
Conference Call, Webcast and Prepared Statement Information
Agenus executives will host a conference call at 11:00 a.m. Eastern Time
today. To access the live call, dial 1-888-799-5016 (U.S.) or
1-704-908-0465 (international) and refer to conference ID number
91108969. 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 60 days.
Agenus is an immuno-oncology company focused on the discovery and
development of revolutionary new treatments that engage the body's
immune system to benefit patients suffering from cancer. By combining
multiple powerful platforms, Agenus has established a highly integrated
approach to target identification and validation, and for the discovery,
development and manufacturing of monoclonal antibodies that modulate
targets of interest. The Company's broad portfolio of novel checkpoint
and other immuno-modulatory monoclonal antibodies, vaccines and
adjuvants, work in combination to provide the opportunity to create
best-in-class therapeutic regimens. Agenus' heat shock protein-based
vaccine, Prophage , has successfully completed Phase 2 trials in
newly-diagnosed glioblastoma. The Company has formed collaborations with
Merck and Incyte to discover and develop multiple checkpoint antibodies.
For more information, please visit www.agenusbio.com; information
that may be important to investors will be routinely posted on our
| Summary Consolidated Financial Information | |||||||||
| Condensed Consolidated Statements of Operations Data | |||||||||
| (in thousands, except per share data) | |||||||||
| (unaudited) | |||||||||
| Three months ended March 31, | |||||||||
| 2016 | 2015 | ||||||||
| Revenue | $ | 5,959 | $ | 3,953 | |||||
| Operating expenses: | |||||||||
| Research and development | 25,038 | 9,220 | |||||||
| General and administrative | 9,232 | 5,487 | |||||||
| Non-cash contingent consideration fair value adjustment | (342 | ) | 7,538 | ||||||
| Operating loss | (27,969 | ) | (18,292 | ) | |||||
| Other expense, net | (3,810 | ) | (450 | ) | |||||
| Net loss | (31,779 | ) | (18,742 | ) | |||||
| Dividends on Series A-1 convertible preferred stock | (51 | ) | (51 | ) | |||||
| Net loss attributable to common stockholders | $ | (31,830 | ) | $ | (18,793 | ) | |||
| Per common share data, basic and diluted: | |||||||||
| Net loss attributable to common stockholders | $ | (0.37 | ) | $ | (0.28 | ) | |||
| Weighted average number of common shares outstanding, basic and | 86,687 | 66,667 | |||||||
| diluted | |||||||||
| Condensed Consolidated Balance Sheet Data | |||||||||
| (in thousands) | |||||||||
| (unaudited) | |||||||||
| March 31, 2016 | December 31, 2015 | ||||||||
| Cash, cash equivalents and short-term investments | $ | 148,230 | $ | 171,668 | |||||
| Total assets | 221,139 | 242,228 | |||||||
| Total stockholders' equity | 44,453 | 70,728 |
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 development and clinical trial plans,
potential funding and partnership activities, upcoming scientific
conferences and manufacturing capabilities. 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