Agenus Provides Corporate Update and Third Quarter 2022 Financial Report
November 08 2022 - 7:00AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad
pipeline targeting cancers and infectious disease, today provided a
corporate update and reported financial results for the third
quarter of 2022.
“Botensilimab has demonstrated impressive clinical responses in
nine cold, treatment-resistant tumor types with strong durability,
and we look forward to presenting expanded data in colorectal,
ovarian, lung and sarcoma cohorts at a plenary session at SITC
followed by our R&D event this Saturday,” said Garo Armen, PhD,
Chairman and Chief Executive Officer of Agenus. “In light of these
compelling clinical data, we have expanded our leadership team to
accelerate the development and seek registration of botensilimab
with the aim of delivering this potentially transformative new
therapy to patients across multiple tumor types.”
Clinical update on botensilimab, Agenus’ innate and
adaptive immune stimulator, to be presented in a plenary session of
the SITC Annual Meeting
- New data on multiple expansion
cohorts from the Phase 1 study of botensilimab in cold
(immunotherapy-resistant) tumors will be presented at an oral
plenary session on novel immunotherapies on Saturday, November 12th
at 10:50am ET.
- Two additional SITC presentations
will include new data on the mechanisms underpinning botensilimab’s
differentiated and enhanced anti-tumor immunity.
Initiated Phase 2 ACTIVATE trials in advanced MSS
colorectal cancer and melanoma
- ACTIVATE-Colorectal is a global,
randomized, open-label, dose-optimization study evaluating the
safety and efficacy of botensilimab as monotherapy and in
combination with balstilimab in advanced refractory MSS CRC
patients.
- ACTIVATE-Melanoma is a global,
randomized, open-label, multi-cohort, dose-optimization study
evaluating the safety and efficacy of botensilimab as a single
agent in advanced refractory melanoma who have failed prior PD-1
+/- CTLA-4 therapy.
- An additional Phase 2 study in
pancreatic cancer is anticipated to begin later in 2022.
Expanded clinical and regulatory leadership team to
accelerate botensilimab development
- Patricia Carlos named Chief
Regulatory, Quality, and Safety Officer. Patricia brings over 20
years of regulatory affairs leadership experience, directing
programs from investigational new drug application to
commercialization including prior regulatory and quality leadership
roles at Arcus Biosciences, BeiGene, Medivation, Gilead Sciences,
and Bayer.
- Todd Yancey, MD named Senior Global
Clinical Development, Medical Affairs and Commercial Advisor. Todd
brings over 40 years of combined clinical and industry experience,
including prior global clinical and commercial leadership roles at
Beigene, BioMarin, Medivation, Onyx, Genentech, and Amgen.
Continued to advance clinical pipeline through
company-led studies and corporate partnerships
- Dosed first patient in Phase 1 study
of AGEN1571 (ILT2 antagonist) as a monotherapy and in combination
with botensilimab and/or balstilimab in participants with advanced
solid tumors.
- Combination study with AGEN2373
(CD137 agonist) and botensilimab in melanoma patients who have
relapsed or are refractory to prior anti-PD-1 therapy continues to
enroll.
- Update on the Phase 2 trial of
AGEN1423, an anti-CD73-TGFβ-trap bifunctional antibody in
combination with balstilimab (anti-PD-1) in advanced pancreatic
cancer will be presented at SITC.
- BMS launched a Phase I/II study of
BMS-986442 (a TIGIT bispecific discovered by Agenus, also known as
AGEN1777) in combination with nivolumab +/- chemotherapy in
patients with advanced solid tumors and non-small cell lung
cancer.
- Merck has initiated a randomized
Phase II study evaluating MK-4830 (a candidate ILT4 antagonist
discovered by Agenus) in combination with pembrolizumab and
chemotherapy in ovarian cancer; additional Phase II studies are
ongoing in NSCLC, small cell lung cancer, esophageal cancer, MSI-H
colorectal cancer, renal cell carcinoma, and melanoma.
- Incyte has initiated a randomized
Phase II study evaluating INCAGN02385 (LAG-3) and INCAGN02390
(TIM-3), both discovered by Agenus, in combination with anti-PD-1
in 1L squamous cell carcinoma of the head and neck; additional
Phase II studies are ongoing in melanoma, endometrial cancer, and
urothelial carcinoma.
Third Quarter 2022 Financial ResultsWe ended
our third quarter 2022 with a cash, cash equivalent, and short-term
investment balance of $218.2 million as compared to $238.3 million
and $306.9 million on June 30, 2022, and December 31, 2021,
respectively. Cash used in operations was $32.2 million for the
quarter ended September 30, 2022, and $128 million for the
nine-months then ended.
We recognized revenue of $22.8 million and incurred a net loss
of $56.7 million, or $0.19 per share, for the third quarter ended
September 30, 2022. For the nine-months ended September 30, 2022,
we recognized revenue of $69.6 million and incurred a net loss of
$156.6 million, or $0.54 per share.
Non-cash operating expenses for the third quarter and
nine-months ended September 30, 2022, were $22.2 million and $62.8
million respectively.
Select Financial Information |
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(in thousands, except per share data) |
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(unaudited) |
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September 30,2022 |
December 31,2021 |
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Cash, cash equivalents and short-term investments |
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$ |
218,230 |
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$ |
306,923 |
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Three months ended September 30, |
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Nine months ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenues, royalty sales milestone |
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$ |
7,934 |
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$ |
- |
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$ |
25,250 |
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$ |
- |
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Revenues, non-cash royalty |
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9,224 |
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12,593 |
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27,001 |
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28,903 |
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Revenues, research and development |
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4,573 |
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238,986 |
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13,220 |
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242,265 |
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Revenues, other |
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1,041 |
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1,375 |
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4,167 |
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4,236 |
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Total Revenue |
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22,772 |
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252,954 |
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69,638 |
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275,404 |
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Research and development expenses |
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46,011 |
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42,937 |
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133,412 |
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125,122 |
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General and administrative expenses |
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18,105 |
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21,385 |
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55,971 |
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54,388 |
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Cost of service revenue |
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308 |
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817 |
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2,875 |
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2,589 |
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Other income |
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(971 |
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(6,035 |
) |
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(9,745 |
) |
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(7,404 |
) |
Non-cash interest expense |
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16,041 |
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16,298 |
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44,629 |
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48,295 |
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Non-cash contingent consideration fair value adjustment |
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(7 |
) |
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275 |
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(950 |
) |
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13,531 |
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Net (loss) income |
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$ |
(56,715 |
) |
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$ |
177,277 |
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$ |
(156,554 |
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$ |
38,883 |
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Net (loss) income per share attributable to Agenus Inc. common
stockholders, basic |
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$ |
(0.19 |
) |
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$ |
0.76 |
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$ |
(0.54 |
) |
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$ |
0.19 |
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Net (loss) income per share attributable to Agenus Inc. common
stockholders, diluted |
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$ |
(0.19 |
) |
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$ |
0.72 |
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$ |
(0.54 |
) |
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$ |
0.18 |
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Cash (used in) provided by operations |
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$ |
(32,191 |
) |
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$ |
131,373 |
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$ |
(128,035 |
) |
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$ |
33,072 |
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Non-cash operating expenses |
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$ |
22,194 |
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$ |
23,127 |
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$ |
62,814 |
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$ |
81,421 |
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Conference CallTuesday, November 8, 2022,
8:30am ETDial-in numbers: (646) 307-1963 (US-NY) or (800) 715-9871
(US & CA)Event ID: 6199615
WebcastA 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/2truok3j.
“The Road Taken” R&D EventAgenus will host
an in-person and virtual R&D event (“The Road Taken”) on
Saturday, November 12th from 2:00 p.m. to 5:00 p.m. ET at the
Prudential Tower in Boston, MA. The event will feature insights
from leading cancer immunologists who will share their collective
and individual expertise on the current and future state of cancer
immunotherapy, including a deep dive into the botensilimab data
presented at SITC. Institutional investors, research analysts, and
key opinion leaders are invited to attend the event in-person and
can RSVP by emailing investorrelations@agenusbio.com. To register
for the live webcast, please click here.
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 and infections. 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), and adjuvants
(through its subsidiary SaponiQx). 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 relating to our technologies,
therapeutic candidates, and capabilities, for instance, statements
regarding therapeutic benefit and efficacy, mechanism of action,
potency, durability, and safety and tolerability profile of our
therapeutic candidates, both alone and in combination with each
other and/or other agents; statements regarding future plans,
including research, clinical, regulatory, and commercialization
plans; and any other statements containing the words "may,"
"believes," "expects," "anticipates," "hopes," "intends," "plans,"
"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 and
available on our website: www.agenusbio.com. 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.Nico FrelickInvestor
Relations781-674-4616nico.frelick@agenusbio.com
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