Agenus Corporate Update and First Quarter 2021 Financial Report
May 06 2021 - 7:45AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of checkpoint antibodies, cell therapies,
adjuvants, and vaccines designed to activate immune response to
cancers and infections, today provided a corporate update and
reported financial results for the first quarter of 2021.
“We have delivered on multiple key initiatives since our last
update and expect to achieve additional impactful milestones during
the remainder of the second quarter and the rest of 2021,” said
Garo Armen, PhD, Chief Executive Officer of Agenus. “Among
important developments are the continuing clinical responses we are
seeing with AGEN1181. We intend to advance AGEN1181 in combination
with balstilimab in cancers for which current immunotherapies have
shown no activity given AGEN1181’s positive clinical responses in
these tumors. Treating these cancers successfully will be of
substantial value to patients while potentially representing large
commercial opportunities for Agenus.”
Balstilimab (anti-PD-1): BLA submitted to U.S. FDA for
recurrent/metastatic cervical cancer
- A Biologics License Application (BLA) was submitted to the U.S.
Food and Drug Administration (FDA) for the accelerated approval of
balstilimab for the treatment of patients with recurrent or
metastatic cervical cancer with disease progression on or after
chemotherapy.
- The submission was based on an update to data presented at the
European Society for Medical Oncology (ESMO) Virtual Congress 2020
and published in an Oncogene editorial. This updated dataset
includes maturation of late patient responses, with the overall
data showing response rates of 20% in PD-L1 positive tumors, 15% in
all tumors (PD-L1 positive and negative), and a median duration of
response of 15.4 months.
- Data demonstrating that balstilimab is a potentially
differentiated anti-PD-1 antibody will be presented at the 2021
American Society for Clinical Oncology (ASCO) Annual Meeting from
June 4 – 8, 2021.
- Discussions with the FDA regarding accelerated BLA filing for
balstilimab plus zalifrelimab are ongoing; additional guidance and
updated response rate data will be provided upon the FDA acceptance
of the balstilimab monotherapy BLA.
AGEN1181 (anti-CTLA-4): Data demonstrate continued
strong activity, including in tumors unresponsive to immunotherapy,
as presented at AACR 2021
- At the American Association for Cancer Research (AACR) annual
meeting, a new partial response with AGEN1181 monotherapy was
reported in the first and only melanoma patient treated to date, as
well as a new conversion to complete response with AGEN1181 plus
balstilimab in an ovarian cancer patient.
- Continued clinical activity in patients with biomarkers which
indicate a poor prognosis with approved immunotherapies, including
patients with microsatellite stable (MSS) tumors and melanoma,
endometrial, and ovarian cancer with the low-affinity FcyRIIIA
allele. No immune-mediated hypophysitis, pneumonitis, or hepatitis
were reported.
- As of AACR 2021, a total of seven confirmed objective responses
were achieved in a Phase 1/2 trial of AGEN1181 in solid tumors out
of 52 evaluable patients: 2 confirmed responses among 21 treated
with monotherapy, and 5 confirmed responses among 31 treated with
AGEN1181 in combination with balstilimab.
- Phase 2 trial in colorectal cancer was initiated;
registrational trials are targeted to commence in 2021 with a focus
on indications enabling a rapid path to BLA submission. Further
data updates expected later this year.
AGEN1777 (anti-TIGIT bispecific): Phase 1 anticipated
2021
- IND submission is planned for the current quarter.
- Phase 1 study is expected to commence in the third
quarter.
Intelligent cell platform: Phase 1 study ongoing with
iNKT cell therapy in patients with cancer and ARDS secondary to
COVID-19
- Phase 1 trial in hematologic cancers was initiated; expansion
into solid tumors is expected this year.
- Preliminary Phase 1 data for acute respiratory distress
syndrome (ARDS) secondary to COVID-19 suggest iNKTs (invariant
natural killer T cells) can be dosed without adverse events
attributable to the therapy and may demonstrate early signals of
activity. Dose escalation is expected to be completed this year
with data readouts to be presented at upcoming conferences.
Additional programs and initiatives continue to
advance
- A data update on a Phase 1 trial of AGEN2373 (a CD137 agonist
antibody) will be presented at the 2021 ASCO Annual Meeting.
- Agenus entered into a clinical collaboration with Nelum
Pharmaceuticals for zalifrelimab in combination with NLM-001,
Nelum’s small molecule hedgehog inhibitor, and chemotherapy for
first-line advanced pancreatic cancer.
First Quarter Financial Results
We ended our first quarter 2021 with a cash balance of $119
million as compared to $100 million at December 31, 2020.
Cash used in operations for the three months ended March 31,
2021 was $43 million compared to $35 million for the quarter ended
March 31, 2020. Net loss for the quarter ended March 31, 2021 was
$54 million or $0.27 per share which includes non-cash expenses of
$12 million compared to a net loss for the same period in 2020 of
$45 million, or $0.31 per share which includes non-cash expenses of
$3 million.
We recognized revenue of $12 million and $15 million for the
quarters ended March 31, 2021 and 2020, respectively, which
includes revenue related to non-cash royalties earned and revenue
recognized under our collaboration agreements.
Select
Financial Information |
|
(in thousands,
except per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
119,366 |
|
$ |
99,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
Revenues,
research and development |
$ |
1,571 |
|
$ |
1,928 |
|
Revenues,
non-cash royalty |
|
8,484 |
|
|
13,156 |
|
Revenues,
other |
|
1,664 |
|
|
44 |
|
Total Revenue |
|
11,719 |
|
|
15,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses |
|
36,677 |
|
|
36,363 |
|
General and
administrative expenses |
|
16,352 |
|
|
10,613 |
|
Cost of
service revenue |
|
1,105 |
|
|
- |
|
Other
expense (income) |
|
(2,579) |
|
|
1,243 |
|
Non-cash
interest expense |
|
15,611 |
|
|
13,844 |
|
Loss on
modification of debt |
|
- |
|
|
2,720 |
|
Non-cash
contingent consideration fair value adjustment |
|
(1,044) |
|
|
(4,384) |
|
Net
loss |
$ |
(54,403) |
|
$ |
(45,271) |
|
|
|
|
|
|
|
|
Net loss per
share attributable to Agenus Inc. common stockholders: |
$ |
(0.27) |
|
$ |
(0.31) |
|
|
|
|
|
|
|
|
Cash used in
operations |
$ |
42,744 |
|
$ |
34,505 |
|
|
|
|
|
|
|
|
Conference CallDial-in numbers: (800) 446-1671
(US) or (847) 413-3362 (International); Confirmation Number:
50150591
WebcastA live webcast and replay of the
conference call will be accessible from the Events &
Presentations page of the Company’s website at
https://investor.agenusbio.com/events-and-presentations and via
https://edge.media-server.com/mmc/p/dbt4fxyo.
About AgenusAgenus 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 StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding clinical development and regulatory plans and
timelines, anticipated corporate milestones, new clinical data and
program updates to be presented, and the anticipated commercial
launch of balstilimab. 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.
ContactAgenus Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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