Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of checkpoint antibodies, adjuvants, and
vaccines designed to activate immune response to cancers and
infections, today provided a corporate update and reported
financial results for the third quarter of 2021.
“With more than 100 patients treated with our Fc-enhanced CTLA-4
antibody, AGEN1181, we are very encouraged by the clinical
responses achieved across tumor types. Of note, we are seeing
responses in patients who have failed to respond to all other
treatment, including PD-1 inhibitors,” said Garo Armen, PhD,
Chairman and Chief Executive Officer of Agenus. “We will be
presenting detailed trial results at the SITC conference this week.
We have also successfully completed an initial public offering for
MiNK Therapeutics, and have launched our adjuvant business,
SaponiQx.”
AGEN1181 (Fc-enhanced CTLA-4), as a monotherapy and in
combination with balstilimab (anti PD-1), shows clinical benefit in
9 cold and treatment-resistant tumor types; data to be presented at
SITC
- First presentation
of clinical data from 100+ patients who represent a heavily
pre-treated population, and were administered AGEN1181 as a
monotherapy or in combination with balstilimab
- Evidence of AGEN1181 monotherapy
activity with multiple confirmed responses: microsatellite stable
(MSS) - endometrial cancer (CR), melanoma (PR), cervical cancer
(PR), and pancreatic cancer (PR), with the former three responses
occurring in tumors which failed to respond to anti-PD-1
therapy
- Additional responses
in patients treated with AGEN1181 in combination with balstilimab,
including in cold, poorly immunogenic tumors. These include:
- Microsatellite stable colorectal
cancer (MSS-CRC): 2 confirmed PRs, 2 unconfirmed PRs, and 7 stable
disease (SD) among 17 evaluable patients for a disease control rate
of 65%
- Gynecological malignancies: 2 PRs, 3
SDs among 6 evaluable ovarian cancer patients; 1 PR and 1
unconfirmed PR in MSS-endometrial cancer
- Other tumors: 2 unconfirmed
responses in visceral angiosarcoma, and one unconfirmed response in
PD-1-relapsed/refractory NSCLC
- Majority of responses are durable
and ongoing, with additional data to be presented at SITC on
November 12th (Abstract # 479)
- Both monotherapy and combination
therapy were well tolerated, with no cases of hypophysitis or
pneumonitis
- Based on these data, Agenus will
commence Phase 2/3 trials evaluating AGEN1181, as a monotherapy and
in combination with balstilimab, in colorectal and gynecological
cancers
MiNK Therapeutics launched an IPO; its stock is trading
on NASDAQ
- MiNK Therapeutics launched a
successful IPO, raising >$40M to support the rapid clinical
development of its allogeneic cell therapies
- MiNK has three presentations planned
at SITC, which will showcase data on clinical-stage, allogeneic,
iNKT cell therapy (AgenT-797), including clinical persistence and
activity, preclinical anti-tumor activity and tissue distribution,
as well as the tumor killing potential of engineered iNKT cells
generated by leveraging a proprietary CAR platform
SaponiQx launch to accelerate development of proven and
novel adjuvants, as well as optimized antigen-adjuvant
constructs
- Will address global need for
vaccines offering long-lasting efficacy with secure production,
which has been amplified by the current pandemic
- QS-21 Stimulon™ adjuvant is proven
to drive durable immunity - SHINGRIX® (GSK zoster vaccine,
recombinant) offers protection of >9 years
- Collaborating with Phyton Biotech
and Ginkgo Bioworks to develop and optimize a plant cell culture
method of manufacturing QS-21 and next-generation saponin- based
adjuvants for a secure and sustainable adjuvant supply
First patients dosed in multiple collaborator
programs
- First patient dosed with AGEN1777,
our Fc-enhanced TIGIT bispecific antibody licensed to BMS,
triggering a $20 million milestone payment. BMS intends to advance
AGEN1777 in high-priority indications, such as non-small cell lung
cancer
- First patient dosed in clinical
collaboration with Nelum, evaluating our first-generation CTLA-4,
zalifrelimab, in combination with Nelum’s hedgehog inhibitor and
chemotherapy in first-line pancreatic cancer
Planning underway to launch expanded access programs for
balstilimab
- BLA for balstilimab in second-line
cervical cancer was withdrawn after full approval of pembrolizumab,
four months ahead of the FDA goal date, based on data for
pembrolizumab plus chemotherapy in first-line setting
- Agenus will discontinue the
confirmatory trial, resulting in a >$100M expense reduction
- As balstilimab met trial endpoints
with ORR of 20% in PD-L1 positive tumors and 8% in PD-L1 negative
tumors, Agenus plans to launch an expanded access program in
several countries, including the US, pending regulatory
processes
- Combination of balstilimab and
zalifrelimab resulted in a near doubling of responses (33% vs. what
has been reported with pembrolizumab in PD-L1+ cervical cancer
patients); data was presented at this year’s ESMO Conference
Third Quarter 2021 Financial Results
We ended the third quarter of 2021 with a cash and short-term
investment balance of $262 million as compared to $100 million at
December 31, 2020.
For the third quarter ended September 30, 2021, our cash
provided by operations was $131 million and we reported a net
income of $177 million or $0.76 per share basic and $0.72 per share
diluted. This compares to cash used in operations for the same
period in 2020 of $32 million and a net loss of $52 million or
$0.28 per share basic and diluted.
Our cash provided by operations for the nine-months ended
September 30, 2021 was $33 million with net income of $39 million
or $0.19 per share basic and $0.18 per share diluted, compared to
cash used in operations of $104 million and a net loss for the same
period in 2020 of $145 million or $0.87 per share, basic and
diluted. Non-cash operating expenses for the nine-months ended
September 30, 2021 were $46 million compared to $35 million for the
same period of 2020.
We recognized revenue of $275 million and $57 million for the
nine-months ended September 30, 2021 and 2020, respectively, which
includes revenue related to upfront license fees received and
milestones earned, non-cash royalties, and revenue recognized under
our collaboration agreements.
Financial Highlights |
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(in thousands, except per share data) |
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(unaudited) |
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September 30, 2021 |
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December 31, 2020 |
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Cash, cash equivalents and short-term investments |
$ |
261,528 |
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$ |
99,871 |
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Three months ended September 30, |
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Nine months ended September 30, |
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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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$ |
238,986 |
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$ |
4,286 |
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$ |
242,265 |
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$ |
24,283 |
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Revenues, non-cash royalty |
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12,593 |
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8,947 |
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28,903 |
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29,950 |
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Revenues, other |
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1,375 |
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1,599 |
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4,236 |
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2,673 |
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Total Revenue |
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252,954 |
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14,832 |
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275,404 |
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56,906 |
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Research and development expenses |
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42,937 |
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32,134 |
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125,122 |
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107,048 |
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General and administrative expenses |
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21,385 |
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14,380 |
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54,388 |
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39,188 |
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Cost of service revenue |
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817 |
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911 |
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2,589 |
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1,545 |
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Other expense (income) |
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162 |
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939 |
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(1,207 |
) |
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2,805 |
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Non-cash interest expense |
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16,298 |
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15,918 |
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48,295 |
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44,109 |
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(Gain) loss related to debt |
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(6,197 |
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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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275 |
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2,196 |
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13,531 |
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4,652 |
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Net income (loss) |
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$ |
177,277 |
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$ |
(51,646 |
) |
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$ |
38,883 |
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$ |
(145,161 |
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Net income (loss) per share attributable to Agenus Inc. common
stockholders, basic |
$ |
0.76 |
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$ |
(0.28 |
) |
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$ |
0.19 |
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$ |
(0.87 |
) |
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Net income (loss) per share attributable to Agenus Inc. common
stockholders, diluted |
$ |
0.72 |
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$ |
(0.28 |
) |
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$ |
0.18 |
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$ |
(0.87 |
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Cash provided by (used in) operations |
$ |
131,373 |
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$ |
(31,626 |
) |
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$ |
33,072 |
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$ |
(103,506 |
) |
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Non-cash operating expenses |
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$ |
4,337 |
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$ |
14,375 |
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$ |
46,321 |
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$ |
35,181 |
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Conference CallTuesday, November 9, 2021,
8:30am ETDial-in numbers: (833) 614-1394 (US) or (914) 987-7115
(International); Conference ID: 8585893.
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/mr7ep4vu.
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 affiliate 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 AGEN1181,
zalifrelimab, balstilimab AGEN1777, and iNKT cell therapy
(AgenT-797) , for instance, statements regarding therapeutic
benefit and efficacy, mechanism of action, potency, durability, and
safety profile of the therapeutic candidates, both alone and in
combination with each other and/or other agents (e.g., AGEN1181 in
combination with balstilimab); statements relating to future
clinical and regulatory development plans for therapeutic
candidates alone and in combination with other agents, including
AGEN1181 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 future commercial plans, including
those related to the receipt of future milestone payments and
collaboration and license arrangements; statements relating to our
ability to develop novel adjuvants and accelerate the development
of adjuvants, as well as statements relating to our ability to
develop optimized antigen-adjuvant constructs and develop and
optimize manufacturing methods for QS-21 and other adjuvants;
statements relating to planned savings; ; and any other statements
containing the words "may," "believes," "expects," "anticipates,"
"hopes," "intends," "plans," "forecasts," "estimates," "will" 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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