Agenus Corporate Update and Fourth Quarter & Full Year 2020 Financial Report
March 15 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 fourth quarter and full year
2020.
“2020 was a pivotal year for Agenus, marking the beginning of
our transition to a commercial company with the initiation of our
rolling BLA filing for balstilimab monotherapy. We also reported
positive data on multiple programs,” said Garo Armen, PhD, Chief
Executive Officer of Agenus. “We expect 2021 to be even more
impactful, with the expected completion of our balstilimab
monotherapy BLA filing in the first half. This filing, followed by
an anticipated commercialization, will provide a solid foundation
to support the development of our next-generation pipeline. Our
best-in-class pipeline reveals true differentiation potential,
notably our next-generation anti-CTLA-4 AGEN1181 and our anti-TIGIT
bispecific AGEN1777.”
Balstilimab (anti-PD-1): BLA completion expected in
first half of 2021
- Balstilimab accelerated approval in second line cervical cancer
expected to be a significant milestone in the transition to a
commercial company and a key inflection point for Agenus’
combinations strategy both with its own pipeline agents and with
partnered products
- Balstilimab shows differentiation from commercial PD-1s and
achieves response rates of 19% in PD-L1 positive tumors with 14% in
all tumors (PD-L1 positive and negative) and a median duration of
response of 15.4 months in a Phase 2 trial. Data presented at the
European Society for Medical Oncology (ESMO) Virtual Congress 2020
and in an Oncogene editorial
- Balstilimab + zalifrelimab Phase 2 trial in second line
cervical cancer achieves response rates of 27% in PD-L1 positive
tumors with 22% in all tumors (PD-L1 positive and negative) with a
median duration of response not yet reached; data presented at ESMO
2020. Responses continue to improve as data matures
- Discussions with the FDA regarding accelerated BLA filing for
balstilimab plus zalifrelimab ongoing; additional guidance and
updated response rate data to be provided upon FDA acceptance of
balstilimab monotherapy BLA
AGEN1181: Clinical data points to superior
next-generation anti-CTLA-4 agent
- As of our February 9th report, six confirmed objective clinical
responses were achieved in Phase 1/2 trial of AGEN1181 out of 46
evaluable patients: 1 confirmed response among 24 treated with
monotherapy, and 5 confirmed responses among 22 treated with
AGEN1181 in combination with balstilimab
- New clinical data to be presented at the American Association
for Cancer Research (AACR) Annual Meeting 2021
- Optimized Fc-enhanced design differentiates AGEN1181 as a more
active next-generation anti-CTLA-4
- Responses seen in patients who do not generally respond to
first-generation anti-CTLA-4 due to a genetic polymorphism, thus
potentially expanding benefit to 3x more patients
- Further, responses seen in cold tumor settings (microsatellite
stable) and in indications that are generally not responsive to
immunotherapy, including colorectal, endometrial, and ovarian
- No complement-mediated toxicities typically seen with
first-generation anti-CTLA-4 agents
- First anti-CTLA-4 to demonstrate clinical depletion of Tregs,
immunosuppressive T cells whose depletion can allow for an improved
antitumor immune response
- Phase 2 trial in colorectal cancer initiated; registrational
trials targeted to commence in 2021 with focus on indications
enabling a rapid path to BLA filing
AGEN1777 (Anti-TIGIT bispecific): Best-in-class
potential; slated for IND filing in 2Q 2021
- Superior antibody candidate for bispecific targeting and Fc
enhancement, designed for best-in-class performance
- Optimized antibody designed to improve upon limited monotherapy
activity of other anti-TIGITs
- Potential to broaden clinical benefit to additional 40% of
patients versus other TIGIT antibodies by expanding benefit to
patients with a genetic polymorphism
- Bispecific design enables dual blockade of tumor growth,
cutting off a potential cancer escape mechanism to TIGIT
blocking
- IND planned for the second quarter of 2021; Phase 1 study to
commence in the third quarter
iNKTs - Intelligent cell therapy: Trial underway in
patients with COVID-19; cancer trials to commence in 1H
2021
- Preliminary Phase 1 data suggest iNKTs can be dosed with no
safety concerns and may demonstrate early signals of activity.
Trial expansion is underway
- Dose escalation expected to be completed in the first half of
2021 for initiation into a Phase 2 trial
- Dosing in Phase 1 study to treat hematologic cancers and solid
tumors expected to commence in the first half of 2021
Partnered program MK-4830: Phase 2 initiated; milestone
received
- MK-4830 (antibody targeting ILT4 licensed to Merck) advanced
into Phase 2 in patients with PD-L1 positive advanced non-small
cell lung cancer
- $10M milestone payment received; Agenus is eligible for up to
an additional $85M in potential milestone payments plus royalties.
Agenus retains 90% of all milestones from Merck and 67% of future
royalties under its Royalty Purchase Agreement with XOMA LLC
- MK-4830 positive Phase 1 data presented at ESMO 2020
Enhancing talent density to drive key
initiatives
- Dr. Steven O’Day, pioneer in I-O and anti-CTLA-4 therapy, joins
as Chief Medical Officer to drive clinical trial development
especially for AGEN1181
- Andy Hurley, a seasoned commercial executive, joins as Chief
Commercial Officer to head Agenus’ efforts as it prepares for
anticipated balstilimab commercialization
- Marc Wiles, an expert in new product approvals, joins as Vice
President of Regulatory Affairs
- Jason Paragas, leader in AI and pandemic surveillance, joins as
Divisional Vice President of Strategic Initiatives
Agenus initiatives in adjuvants, biomarker platforms,
and predictive AI
- First QS-21 milestone payment of $15.1M based on SHINGRIX sales
received from Healthcare Royalty Partners; process for large-scale
production of renewable raw source of QS-21 advancing to GMP
scale-up
- Proprietary VISION platform, along with artificial
intelligence, designed to allow for discovery of novel biomarkers
and design of optimal treatment protocols for patients
- Updates on AGEN2373, our anti-CD137 antibody, and AGEN1223, our
novel bispecific, will be presented at future scientific and
medical conferences
Strategic partnerships expand potential of Agenus
molecules
- Betta Pharmaceuticals licensing agreement for balstilimab and
zalifrelimab in Greater China; Agenus received $35M in cash and
equity and is eligible for up to $100M in milestones plus
royalties
- Rottapharm Biotech access program for balstilimab in
combination with CR6086, a potent and selective prostaglandin EP4
receptor antagonist, in patients with advanced metastatic
colorectal cancer
- Nelum Pharmaceuticals clinical collaboration for zalifrelimab
in combination with NLM-001, Nelum’s small molecule hedgehog
inhibitor, and chemotherapy for first-line advanced pancreatic
cancer
Fourth Quarter and Full Year 2020 Financial
Results
For the year ended December 31, 2020, we recognized revenue of
$88 million which includes revenue related to the upfront license
fee from our transaction with Betta plus non-cash royalties and
milestones earned. For the year ended 2019 we recorded revenue of
$150 million which included revenue related to the upfront license
fee from our transaction with Gilead and milestones earned, in
addition to non-cash royalties earned.
Net loss for the fourth quarter was $38 million or $0.20 per
share compared to a net loss for the same period in 2019 of $31
million, or $0.22 per share. Net loss for the year ended 2020 was
$183 million or $1.05 per share compared to a net loss for the year
ended 2019 of $112 million or $0.80 per share.
Fiscal year end 2020 cash balance was $100 million as compared
to $62 million at fiscal year end 2019.
Financial
Highlights |
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(in thousands,
except per share data) |
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(unaudited) |
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December 31, |
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2020 |
|
|
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2019 |
|
|
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|
|
|
|
|
|
|
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|
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|
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|
Cash and cash equivalents |
|
|
$ |
99,871 |
|
|
$ |
61,808 |
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Three months ended
December, |
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Year ended December
31, |
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2020 |
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2019 |
|
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|
2020 |
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2019 |
|
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|
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Revenues, research and development |
|
$ |
11,632 |
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$ |
18,824 |
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|
$ |
35,915 |
|
|
$ |
99,845 |
|
|
Revenues, non-cash royalty and milestones |
|
17,595 |
|
|
|
352 |
|
|
|
47,545 |
|
|
|
30,424 |
|
|
Revenues, royalty sales milestone |
|
|
- |
|
|
|
15,100 |
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|
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- |
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15,100 |
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Revenues, other |
|
|
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2,038 |
|
|
|
226 |
|
|
|
4,710 |
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|
|
4,679 |
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Total Revenue |
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|
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31,265 |
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|
|
34,502 |
|
|
|
88,170 |
|
|
|
150,048 |
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Research and development expenses |
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35,571 |
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36,834 |
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142,617 |
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168,339 |
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General and administrative expenses |
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20,030 |
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|
12,319 |
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|
59,218 |
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|
46,041 |
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Cost of service revenue |
|
|
|
804 |
|
|
|
- |
|
|
|
2,349 |
|
|
|
- |
|
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Other expense (income) |
|
|
|
101 |
|
|
|
(209 |
) |
|
|
2,907 |
|
|
|
(778 |
) |
|
Non-cash interest expense |
|
|
|
15,920 |
|
|
|
11,784 |
|
|
|
60,029 |
|
|
|
42,201 |
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Loss on modification of debt |
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- |
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- |
|
|
|
2,720 |
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- |
|
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Non-cash contingent consideration fair value adjustment |
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(3,431 |
) |
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|
4,625 |
|
|
|
1,221 |
|
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|
5,805 |
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Net
loss |
|
|
|
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$ |
(37,730 |
) |
|
$ |
(30,851 |
) |
|
$ |
(182,891 |
) |
|
$ |
(111,560 |
) |
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Net loss per share attributable to Agenus Inc. common
stockholders |
$ |
(0.20 |
) |
|
$ |
(0.22 |
) |
|
$ |
(1.05 |
) |
|
$ |
(0.80 |
) |
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Cash used in operations |
|
|
$ |
(35,590 |
) |
|
$ |
(31,780 |
) |
|
$ |
(139,096 |
) |
|
$ |
(18,682 |
) |
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Conference Call
Dial-in numbers: (833) 614-1394 (US) or (914) 987-7115
(International); Conference ID: 2339028.
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/3f7iind8.
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 at AACR, 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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