LEXINGTON, Mass., Aug. 3, 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 second
quarter ended June 30, 2017.
"In the second quarter, we advanced our anti-CTLA-4 and
anti-PD-1 antibodies in preparation for initiating combination
trials in the second half of this year. We also produced GMP grade
product in our facilities in Berkeley and selected a commercial
supplier for our lead antibodies. In addition, our partnering
efforts are maturing and we expect to close on several transactions
in the second half of this year," said Garo
H. Armen, Ph.D., Chairman and CEO of Agenus. "We are
committed to our path of generating potential first-in-class and
best-in-class immuno-oncology agents, and doing so with speed,
quality and efficiency."
Anticipated Milestones for H2 2017:
- AGEN1884 (anti-CTLA-4) Phase 1 trial: complete dose-escalation
and compile safety and pharmacodynamic data
- AGEN2034 (anti-PD-1) Phase 1/2 trial:
-
- Complete dose-escalation for monotherapy, define optimal
combination dose and collect safety and receptor occupancy
data
- Recruit patients with second line cervical cancer
- AGEN1884+AGEN2034 Phase 1b trial: commence combination
trial
- AutoSynVax™ (neoantigen vaccine): immunological readouts
expected in patients with advanced malignancies
- Advance our cell therapy spin off efforts
- Secure substantial funds from existing agreements and future
transactions
Recent Highlights:
- AGEN1884 interim data presented at ASCO:
-
- Safe at doses up to 3 mg/kg
- Partial response in a patient with angiosarcoma with 92%
reduction in tumor burden at 0.1 mg/kg dose (since ASCO this
patient has experienced a complete response)
- QS-21 Stimulon® update:
-
- GSK's shingles vaccine containing Agenus' QS-21 Stimulon
adjuvant showed strong immunogenicity in patients previously
treated with standard of care (Merck's Zostavax®)
- U.S. regulatory approval of Shingrix is anticipated in Q4
- Manufacturing readiness:
-
- Agenus West successful GMP production of AGEN2034 at 1,000L
scale
- Selection of CMOs for production of commercial grade material
for planned registrational trials
Second Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments were
$96.8 million at June 30, 2017 compared to $76.4 million as of December 31, 2016.
For the six months ended June 30,
2017, Agenus reported a net loss of $48.8 million, or $0.51 per share, compared with a net loss for the
same period in 2016 of $60.1 million
or $0.69 per share. The
decrease in net loss for the six months ended June 30, 2017, compared to the net loss for the
same period in 2016, was primarily due to the accelerated milestone
payment received from Incyte during the first quarter of
2017. Our operating expenses increased $9.2 million over the same period in 2016.
For the second quarter ended June 30,
2017, Agenus reported a net loss of $31.7 million, or $0.32 per share, compared with a net loss for the
second quarter of 2016 of $28.3
million, or $0.33 per share.
The increase in net loss for the three months ended June 30, 2017, compared to the net loss for the
same period in 2016, was 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, August 3, 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
http://investor.agenusbio.com/presentation-webcasts. 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 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.
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 milestones for the second
half of 2017, and the expected timing for FDA approval of GSK's
Shingrix vaccine candidate containing Agenus' QS-21 Stimulon®
adjuvant. 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.
Michael Plater
781-674-4504
michael.plater@agenusbio.com
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
June 30,
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Six months ended June
30,
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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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$
4,207
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$
6,592
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$
31,163
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$
12,551
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Operating
expenses:
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Research and
development
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25,824
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22,362
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58,464
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47,400
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General and
administrative
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8,136
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7,117
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15,906
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16,349
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Non-cash contingent
consideration fair value adjustment
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(865)
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721
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(1,061)
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379
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Operating
loss
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(28,888)
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(23,608)
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(42,146)
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(51,577)
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Other expense,
net
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(2,825)
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(4,712)
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(6,670)
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(8,521)
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Net loss
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(31,713)
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(28,320)
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(48,816)
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(60,098)
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Dividends on Series
A-1 convertible preferred stock
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(51)
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(51)
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(103)
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(102)
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Net loss attributable
to common stockholders
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$
(31,764)
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$
(28,371)
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$
(48,919)
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$
(60,200)
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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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$
(0.32)
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$
(0.33)
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$
(0.51)
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$
(0.69)
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Weighted average
number of common shares outstanding, basic and diluted
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99,202
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86,965
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96,371
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86,826
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Condensed
Consolidated Balance Sheet Data
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(in
thousands)
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(unaudited)
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June 30,
2017
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December 31,
2016
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Cash, cash
equivalents and short-term investments
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$
96,766
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$
76,437
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Total
assets
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176,491
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156,986
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Total stockholders'
deficit
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(17,481)
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(39,126)
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SOURCE Agenus Inc.