LEXINGTON, Mass., May 7, 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
first quarter of 2020.
"We accelerated the development of AGEN1181, advanced our plans
to file our BLAs and filed two INDs for our allogeneic iNKT cell
therapy to treat cancer and COVID-19," said Garo Armen, Ph.D., Chairman and CEO, Agenus.
"Our ability to rapidly enroll in our bali and zali
trials, in just 2 years, underscores the speed with which we
can advance our AGEN1181 +/- bali and our innovative
pipeline of products including allogeneic cell therapy
programs."
- AGEN1181, reveals clinical
benefit1 in >70% of response-evaluable
patients
Early data suggest that AGEN1181 could be a
breakthrough in IO treatment:
-
- Confirmed CR with AGEN1181 (1 mg/kg) in advanced
endometrial cancer with a poor prognosis
- Confirmed PR (significant tumor reduction) in advanced
endometrial cancer with low-dose AGEN1181 + balstilimab
- Disease stabilization in the majority of response-evaluable
patients
- Advisory board endorsed accelerated plans
for AGEN1181 development
- Balstilimab & zalifrelimab demonstrate ~26% response
rates which are durable in an all-comer, non-biomarker selected
population
-
- Large cohort analysis (n=55) bali + zali demonstrate
~26% response rates (4 CRs, 10 PRs) in refractory cervical
cancer
- Responses are durable over 12 months
- Allogeneic iNKTs advancing to clinic for the treatment of
cancer and COVID-19
-
- COVID-19: iNKTs designed to eliminate COVID-19 virus,
dampen harmful inflammation, and promote protection from
reinfection (FIM 1H2020)
- CANCER: iNKTs designed to promote anti-tumor immunity in cancer
& enable optimal combinations with Agenus checkpoint
antibodies
- Potential best and first in class TIGIT programs advancing
to IND filing starting in 4Q2020
-
- Fc enhanced TIGIT antibody (AGEN1327) has outperformed all
tested competitor antibodies with superior T cell activation in
PD-1 or LAG-3 combos
- TIGIT bispecific (AGEN1777) demonstrated potent tumor killing
in a difficult to treat colon cancer model where PD-1 antibodies
alone are ineffective
- Key Upcoming Milestones Expected
-
- BLA filings and pre-commercial activities
- IND filings for (2) TIGIT programs in 4Q2020 & 1H2021
- Ongoing read-outs from lead clinical trials (AGEN1181,
Balstilimab, Zalifrelimab)
- Deliver new partnerships
- Reduce annualized burn by $50M to
mitigate any pandemic related business risk
First Quarter Financial Results
We ended the first quarter of 2020 with a cash balance of
$92.3 million as compared to
$61.8 million at December 31, 2019.
For the first quarter ended March 31,
2020, we reported a cash burn from our operations of
$32 million. Net loss for the quarter
was $45 million or $0.31 per share which included non-cash expenses
of $16 million. We generated net
income for the same period in 2019 of $17
million or $0.14 per
share. In the first quarter of 2019 we recognized revenue of
$80 million which included revenue
related to the upfront license fee from our transaction with Gilead
in addition to non-cash royalties earned. For the same period
in 2020 we recorded revenue of $15
million primarily related to non-cash royalties earned.
|
Select Financial
Information
|
|
(in thousands, except
per share data)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
92,284
|
|
$
61,808
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Revenues, research
and development
|
|
$
1,928
|
|
$
70,871
|
|
Revenues, non-cash
royalty
|
|
|
13,156
|
|
8,605
|
|
Revenues,
other
|
|
|
|
44
|
|
415
|
|
Total
Revenue
|
|
|
|
15,128
|
|
79,891
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
36,363
|
|
40,130
|
|
General and
administrative expenses
|
|
10,613
|
|
10,805
|
|
Other expense
(income)
|
|
|
1,243
|
|
(655)
|
|
Non-cash interest
expense
|
|
|
13,844
|
|
9,428
|
|
Loss on modification
of debt
|
|
|
2,720
|
|
-
|
|
Non-cash contingent
consideration fair value adjustment
|
(4,384)
|
|
2,748
|
|
Net (loss)
income
|
|
|
|
$
(45,271)
|
|
$
17,435
|
|
Net (loss) income per
share attributable to Agenus Inc. common stockholders:
|
|
|
|
|
Basic
|
|
|
|
|
$
(0.31)
|
|
$
0.14
|
|
Diluted
|
|
|
|
|
$
(0.31)
|
|
$
0.12
|
|
|
|
|
|
|
|
|
|
|
Cash (used in)
provided by operations
|
|
$
(32,073)
|
|
$
76,587
|
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 or with this
link https://www.webcaster4.com/Webcast/Page/1556/34323.
A replay will be available on the Company's website
approximately one hour after the call and will remain available
until July 7, 2020.
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 the anticipated regulatory and development
timelines, as well as anticipated efficacy of Agenus' TIGIT
programs, AGEN1181 and iNKT cell therapies, the expected reduction
to annual cash burn and anticipated upcoming corporate milestones.
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.
Jennifer S. Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
1 Clinical benefit includes complete response,
partial response, disease stabilization
View original
content:http://www.prnewswire.com/news-releases/agenus-first-quarter-results-and-update-301054567.html
SOURCE Agenus Inc.