LEXINGTON, Mass., March 12, 2020 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of agents designed to activate immune response to cancers
provided a corporate update and reported financial results for the
fourth quarter and full year of 2019.
"We are excited by the clinical responses seen in our phase 1
trial of AGEN1181 alone and in combination with our PD-1," said
Garo Armen, Ph.D., Chairman and CEO,
Agenus. "2020 is a year of clinical data for us; with readouts from
6 separate programs. Additionally, the data we have generated from
our cervical cancer combination trial may represent the most
meaningful treatment option for these patients."
AGEN1181 Clinical Responses in a Phase 1 Trial
Early data suggest that AGEN1181 could be a breakthrough in
IO treatment:
- Low-dose AGEN1181 (1 mg/kg) generated a complete response in
advanced endometrial cancer with a poor prognosis (PD-L1[-], MSS,
CD16a low affinity)
- Low-dose AGEN1181 + balstilimab delivered new partial
responses
- Trial is in dose escalation and expansion to support rapid
development
Updated data of balstilimab & zalifrelimab show 26.5%
objective response rates which are durable in an all-comer,
non-biomarker selected population of patients with refractory
cervical cancer
- Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) in
second line cervical cancer demonstrate 26.5% response
rates (4 CRs, 5 PRs, 8 SD), responses are durable (median not
yet reached 6.9mos+) and may reveal best in class treatment
option
- Combination receives FDA Fast Track designation for the
investigation in relapsed/refractory metastatic cervical
cancer
Key Milestones Expected in 2020
- 2 BLA filings for balstilimab (anti-PD-1) and zalifrelimab
(anti-CTLA-4)
- 3 INDs for new discoveries targeting myeloid & macrophage
biology and allogeneic iNKT cell therapy
- 6 clinical data readouts
- Expect to trigger ~$60M in
milestone payments for the year
- Additional partnerships and/or collaboration discussions
underway
2019: A Year of Financial and Operational
Achievements
- New business development transactions and milestone payments
generated $183 million
-
- $150M initially from our
collaboration with Gilead ($120M in
cash up front and $30M equity
investment). Collected an additional $22.5M in cash milestones.
- $10 million upfront from a
collaboration with Urogen. Potential for ~$200M in future milestones
- Completed accrual and pre-planned interim analysis of two
pivotal trials to support the planned BLA filing of balstilimab and
zalifrelimab in second-line cervical cancer
- Launched 4 clinical programs with our
first-in-class/best-in-class discoveries, including AGEN1181,
AGEN1223, AGEN2373, and GS-1423 (licensed to GILD)
- Advanced allogeneic cell therapy program for planned IND
filing
Fourth Quarter and Full Year 2019 Financial Results
We ended 2019 with a cash balance of $62
million as compared to $53
million at December 31, 2018.
Based on our year end cash balance and cash receipts in our current
quarter, we expect our cash balance to be in excess of $100M at the end of the first quarter of
2020.
Cash used in operations for the quarter ended December 2019 was $32
million compared to $36
million for the same period in 2018. Cash used in operations
for the year ended December 2019 was
$19 million as compared to cash used
in operations of $131 million for the
same period in 2018.
For the fourth quarter ended December 31,
2019, we reported net loss of $31
million or $0.22 per share
compared to a net loss for same period in 2018 of $49 million, or $0.40 per share. For the year ended December 31, 2019, we reported a net loss of
$112 million or $0.80 per share compared to a net loss for the
same period in 2018 of $162 million
or $1.44 per share.
During the year ended December
2019 we recognized revenue of $150
million which includes revenue from our transaction with
Gilead, non-cash royalties earned and a royalty sales
milestone. This compares to revenue of $37 million for the year ended December
2018. For the year ended 2019 we also recorded $42 million of non-cash interest expense due to
our transaction with HCR related to the sale of future
royalties.
Select Financial
Information
|
(in thousands, except
per share data)
|
(unaudited)
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December 31,
2019
|
|
December 31,
2018
|
|
|
|
|
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|
|
|
|
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|
|
|
Cash and cash
equivalents
|
|
|
|
|
$
61,808
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$
53,054
|
|
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Three months ended
December 31,
|
|
Year ended December
31,
|
|
|
|
|
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2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, research
and development
|
|
$
18,824
|
|
$
1,090
|
|
$
99,845
|
|
$
19,475
|
Revenues, non-cash
royalty
|
|
|
352
|
|
5,361
|
|
30,424
|
|
17,309
|
Revenues, royalty
sales milestone
|
|
15,100
|
|
-
|
|
15,100
|
|
-
|
Revenues,
other
|
|
|
|
226
|
|
-
|
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4,679
|
|
-
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Total
Revenue
|
|
|
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34,502
|
|
6,451
|
|
150,048
|
|
36,784
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Research and
development expenses
|
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36,834
|
|
36,031
|
|
168,339
|
|
124,600
|
General and
administrative expenses
|
|
12,319
|
|
9,724
|
|
46,041
|
|
37,340
|
Other expense
(income)
|
|
|
(209)
|
|
887
|
|
(778)
|
|
2,857
|
Non-cash interest
expense
|
|
|
11,784
|
|
8,536
|
|
42,201
|
|
24,599
|
Loss on early
extinguishment of debt
|
|
-
|
|
-
|
|
-
|
|
10,767
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Non-cash contingent
consideration fair value adjustment
|
4,625
|
|
121
|
|
5,805
|
|
(1,335)
|
Net loss
|
|
|
|
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(30,851)
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(48,848)
|
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(111,560)
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(162,044)
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Net loss per share
attributable to Agenus Inc. common stockholders
|
$
(0.22)
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$
(0.40)
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$
(0.80)
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$
(1.44)
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Cash (used in)
provided by operations
|
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$
(31,780)
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$
(35,812)
|
|
$
(18,682)
|
|
$
(131,095)
|
Conference Call, Webcast and Prepared Statement
Information
Date: Thursday, March 12, 2020
Time: 8:30 a.m. ET
Domestic Dial-in Number: 1-844-492-3727 (U.S.)
International Dial-in Number: 1-412-317-5118 (International)
Conference ID: Agenus
The call will also be webcast and will be accessible from the
Company's website
at http://investor.agenusbio.com/presentation-webcasts or
via the
link: https://www.webcaster4.com/Webcast/Page/1556/33333.
A replay will be available on the Company's website
approximately two hours after the call.
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, adoptive cell therapies (through its AgenTus
Therapeutics subsidiary), 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 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.
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' anticipated BLA filings and the
anticipated benefits of Fast Track designation. 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.
Regina Grebla, PhD
781-674-4495
Regina.Grebla@agenusbio.com
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SOURCE Agenus Inc.