Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of checkpoint antibodies and adjuvants 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 2021.
“We made several important advancements in 2021,” said Garo
Armen, PhD, Chief Executive Officer of Agenus. “Our Phase 1 data
presentation at SITC demonstrated the best-in-class potential of
our flagship program, botensilimab, consistent with its Fc-enhanced
design. We partnered our Fc-enhanced TIGIT bispecific with BMS to
accelerate its development in high priority indications such as
NSCLC. This year, we expect to launch several new botensilimab
studies to unlock its franchise potential. In parallel, our R&D
team continues to advance novel discoveries, with our macrophage
targeting program expected to enter the clinic this year.”
Botensilimab is the first anti-CTLA-4 antibody to
demonstrate clinical responses across 9 cold, treatment-resistant
cancers; Phase II studies planned in melanoma,
colorectal, and pancreatic cancers
- Phase 1 data from
>100 patients treated with botensilimab, as monotherapy or in
combination with our PD-1 antibody, balstilimab, presented at
SITC.
- Based on these data, Agenus plans to
commence Phase 2 trials in melanoma, MSS-colorectal, and pancreatic
cancers in order to:
- Demonstrate superiority to
ipilimumab, which has been approved and extensively studied in
melanoma; new melanoma response to botensilimab monotherapy
observed since SITC presentation in a patient who progressed on
prior ipilimumab treatment.
- Build upon potential best-in-class
signal in MSS-colorectal cancer; among 20 patients in our Phase I
study, we observed a 20% response rate for the
botensilimab/balstilimab combination compared to a reported 1%
response rate for a first generation CTLA-4/PD-(L)1
combination.
- Establish botensilimab as superior
combination agent for chemotherapy in cold tumors, by evaluating
botensilimab in combination with standard of care chemotherapy in
pancreatic cancer.
- Positive data in
these studies can unlock the franchise potential of botensilimab,
supporting further development in indications where
first-generation CTLA-4 has been approved or demonstrated benefit,
as well as expansion into indications where botensilimab has shown
benefit but other CTLA-4 agents have not.
- Internal
infrastructure build underway to support botensilimab development
and potential launch: Emeryville site designed to manufacture
inventory worth >$10B in annual sales.
AGEN1571 is entering clinical development in
2022
- AGEN1571 targets tumor associated
macrophages, which promote resistance to PD-1 and CTLA-4
therapy.
- The importance of this target class
has been validated by Merck’s ILT4 antagonist, discovered by
Agenus, which has shown durable responses in PD-1 resistant
cancers.
6 clinical-stage programs advancing through strategic
partnerships; $220M in upfront and achieved milestone payments
received in 2021
- AGEN1777 (Fc-enhanced TIGIT
bispecific) was licensed to BMS for $220M in upfront and achieved
milestones plus $1.36B in future milestones and royalties. BMS
plans to advance AGEN1777 in high priority tumor indications
including NSCLC.
- Merck is advancing a myeloid
cell-targeting antibody, MK-4830, discovered by Agenus, across a
range of cancers – including pancreatic, lung, renal, breast,
ovarian, gastric and glioblastoma.
- Incyte is advancing four clinical
stage partnered programs, including a combination trial evaluating
our TIM-3 and LAG-3 antagonists with PD-1 in PD-1 r/r
melanoma.
- Across our partnerships, we are
eligible for $2.8B in milestones plus royalties, as well as the
option to participate in development and commercialization for
certain programs.
Cell therapy subsidiary, MiNK Therapeutics, launched via
an IPO
- MiNK Therapeutics launched a
successful IPO to support clinical development of its allogeneic
cell therapies.
- Clinical programs are underway in
solid tumors and multiple myeloma.
SaponiQx to generate GMP grade QS-21 STIMULON adjuvant
from proprietary plant cell culture manufacturing process in 2022
to enable partner clinical studies
- QS-21 STIMULON is a proven adjuvant
in GSK’s shingles vaccine (SHINGRIX®), with durability lasting
>9 years.
- While data supports broad
applicability across >20 disease settings, supply is limited by
a complicated extraction process from a Chilean soap bark
tree.
- SaponiQx’s plant cell culture method
of manufacturing offers a more sustainable, scalable, and
cost-effective supply of QS-21 STIMULON.
- GMP grade material from this
manufacturing process is expected to be available this year to
enable partner clinical trials.
- SaponiQx is also developing
next-generation adjuvants designed to increase mucosal immunity
through intranasal delivery, critical for addressing respiratory
pandemic threats such as COVID-19.
Fourth Quarter and Full Year 2021 Financial
Results
We ended the year 2021 with a cash and short-term investment
balance of $307 million as compared to $100 million at December 31,
2020.
We recognized revenue of $296 million and $88 million for the
years ended December 31, 2021, and 2020, respectively, which
includes revenue related to upfront license fees received, non-cash
royalties earned, and revenue recognized under our collaboration
agreements.
Our cash provided by operations for the year ended December 31,
2021, was $10 million with a reported net loss of $29 million or
$0.11 per share compared to cash used in operations of $139 million
and a net loss for the year ended 2020 of $183 million or $1.05 per
share. Non-cash operating expenses for the year ended December 31,
2021, were $49 million compared to $37 million for the year ended
2020.
Net loss for the fourth quarter ended 2021 was $68 million or
$0.26 per share compared to a net loss for the same period in 2020
of $38 million, or $0.20 per share. For the fourth quarter ended
December 31, 2021, our cash used in operations was $23 million
compared to $36 million for the same period in 2020.
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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2021 |
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2020 |
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Cash, cash equivalents and short-term investments |
$ |
306,923 |
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$ |
99,871 |
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Three months ended December, |
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Year ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenues, research and development |
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$ |
2,157 |
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$ |
11,632 |
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$ |
244,422 |
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$ |
35,915 |
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Revenues, non-cash royalty and milestones |
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15,452 |
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17,595 |
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44,355 |
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47,545 |
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Revenues, other |
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2,652 |
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2,038 |
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6,888 |
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4,710 |
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Total Revenue |
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20,261 |
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31,265 |
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295,665 |
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88,170 |
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Research and development expenses |
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53,486 |
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35,571 |
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178,608 |
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142,617 |
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General and administrative expenses |
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21,971 |
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20,030 |
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76,359 |
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59,218 |
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Cost of service revenue |
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|
881 |
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804 |
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3,470 |
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2,349 |
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Other expense (income) |
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(2,744 |
) |
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101 |
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(3,951 |
) |
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2,907 |
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Non-cash interest expense |
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16,324 |
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15,920 |
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64,619 |
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60,029 |
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(Gain) loss related to debt |
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- |
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- |
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(6,197 |
) |
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2,720 |
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Non-cash contingent consideration fair value adjustment |
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(2,050 |
) |
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(3,431 |
) |
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11,481 |
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1,221 |
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Net loss |
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$ |
(67,607 |
) |
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$ |
(37,730 |
) |
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$ |
(28,724 |
) |
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$ |
(182,891 |
) |
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Net loss per share attributable to Agenus Inc. common
stockholders |
$ |
(0.26 |
) |
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$ |
(0.20 |
) |
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$ |
(0.11 |
) |
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$ |
(1.05 |
) |
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Cash provided by (used in) operations |
$ |
(22,927 |
) |
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$ |
(35,590 |
) |
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$ |
10,145 |
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$ |
(139,096 |
) |
Non-cash operating expenses |
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$ |
2,291 |
|
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$ |
(340 |
) |
|
$ |
48,612 |
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$ |
34,841 |
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Conference CallTuesday, March 1, 2022, 8:30am
ETDial-in numbers: (833) 614-1394 (US) or (914) 987-7115
(International)Conference ID: 4651648.
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/5pf7v7jk.
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 subsidiary MiNK Therapeutics), adjuvants,
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 relating to the use of therapeutic candidates
botensilimab, zalifrelimab, balstilimab, AGEN1571, AGEN1777,
AGEN2373, MK-4830, and iNKT cell therapy (MiNK Therapeutics) and
QS-21 STIMULON adjuvant and adjuvants in development (SaponiQx) ,
for instance, statements regarding therapeutic benefit and
efficacy, mechanism of action (including validation of mechanism of
action), potency, durability, and safety profile (including the
absence of specific toxicities) of the therapeutic candidates, both
alone and in combination with each other and/or other agents (e.g.,
botensilimab in combination with balstilimab); statements relating
to future clinical and regulatory development plans for therapeutic
candidates alone and in combination with other agents, including
botensilimab in combination with balstilimab; statements relating
to our ability to obtain regulatory approval for our therapeutic
candidates including the timing (including the possibility of
accelerated review) and scope of any such regulatory approval;
statements relating to our ability to launch expanded access
programs; statements relating to superiority of our therapeutic
candidates over third party therapeutics and therapeutic
candidates;;statements relating to current or future manufacturing
capabilities, manufacturing sustainability and cost-effective
manufacturing; statements relating to future commercial plans,
including those related to commercialization of botensilimab and
the receipt of future milestone payments and collaboration and
license arrangements; statements relating to our ability to develop
novel adjuvants for use in vaccine treatments including COVID-19
treatment, as well as statements relating to our ability to develop
and optimize manufacturing methods for QS-21 STIMULON and other
adjuvants; statements relating to planned savings or efficiencies;
statements relating to future fundraising; and any other statements
containing the words "may," "believes," "expects," "anticipates,"
"hopes," "intends," "plans," "forecasts," "estimates," "will,"
“establish,” “potential,” “superiority,” “best in class,” and
similar expressions are intended to identify forward-looking
statements. 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 Inc.Divya
Vasudevan, PhD781-674-4571divya.vasudevan@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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