Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with a
pipeline of immunological agents targeting cancer and infectious
disease, today provided a corporate update and reported financial
results for the fourth quarter and full year 2022.
"Agenus has entered 2023 with strong momentum across our
extensive and diverse clinical pipeline of immuno-oncology
programs. Our anchor programs, botensilimab (Fc-enhanced,
multi-functional anti-CTLA-4) and balstilimab (anti-PD-1), show
exciting potential in combination to treat a broad spectrum of
treatment-resistant cancers," said Garo Armen, PhD, Chairman, and
Chief Executive Officer of Agenus. "With the growing body of data
demonstrating robust, consistent, and durable efficacy signals from
a trial of over 300 patients across nine metastatic, late-line
cancers, we are expediting the expansion of our
botensilimab/balstilimab development program in MSS CRC and other
priority indications.”
"The number of patients with solid tumors resistant to a
variety of therapies, including current immunotherapies, is
substantial. Existing treatment options for these patients after
failure of initial standard treatments are limited and largely
ineffective, resulting in a short overall survival rate," said Dr.
Steven O'Day, Chief Medical Officer of Agenus. "Botensilimab’s
clinical activity in advanced and refractory cancers has generated
considerable interest from experts worldwide."
2022 Highlights
Botensilimab: Wholly Owned Lead Clinical
Asset
Botensilimab’s clinical results have been presented at a
late-breaking oral session at the American Society of Clinical
Oncology (ASCO GI) in 2023, and in plenary sessions at the European
Society for Medical Oncology (ESMO-GI), Connective Tissue Oncology
Society (CTOS), the Society for Immunotherapy of Cancer (SITC) 2022
annual meetings, as well as at a company-hosted R&D Event ('The
Road Taken'). The latest clinical study results, including those of
the botensilimab and botensilimab/balstilimab combination,
demonstrate durable responses and significant benefits compared to
that reported for standard of care and other investigational
therapies in patients with treatment-resistant tumors.
- MSS CRC: most recent data update presented at
ASCO GIOut of 70 evaluable patients:Survival:
- 12-month overall survival rate of 63%, including 81% for
patients with no active liver metastases, and 40% for patients with
active liver metastases, indicating clinical benefit across all
patient populations.
- Standard of care reported a 12-month overall survival rate of
approximately 25%, inclusive of patients with and without active
liver metastases.1,2
- Median overall survival has not been reached.
- Objective responses:
- Overall response rate of 23%.
- Other PD-(L)1 + CTLA-4 combination regimens in comparable
patient populations have reported response rates of 1-5%.3,4
- 69% of objective responses were ongoing at the data
cut-off.
- Disease control rate was 76% (complete response + partial
response + stable disease).
- Ovarian: most recent data update presented at
SITCOut of 19 evaluable patients:Objective
responses:
- Overall response rate was 26%.
- Other PD-(L)1 + CTLA-4 combination regimens in comparable
patient populations reported response rates of 3-10%.5,6
- Median duration of response has not been reached.
- Disease control rate was 63%.
- Sarcoma: most recent data update presented at
CTOSOut of 13 evaluable patients:Survival:
- 12-month overall survival rate of 77%.
- Median overall survival has not been reached.
- Objective responses:
- Overall response rate of 46%.
- Other PD-(L)1 + CTLA-4 combination regimens in a comparable
patient population reported response rates of 12-16%.7,8
- 67% of objective responses were ongoing at the data
cut-off.
- Disease control rate was 69%.
- Anti-PD-(L)1 Relapsed/Refractory NSCLC: most recent
data update presented at SITCOut of 8
evaluable patients:Objective responses:
- Overall response rate of 50%.
- Other PD-(L)1 + CTLA-4 combination regimens in comparable
patient populations reported response rates of 6-13%.9,10
- Median duration of response has not been reached.
- Disease control rate was 75%.
Since SITC, a total of 4 out of 8
evaluable NSCLC patients have showed objective responses,
consistent with the 50% overall response rate reported at SITC
2022.
Botensilimab: Key Catalysts for 2023
- Complete enrollment of the
randomized Phase 2 ACTIVATE study in MSS CRC of botensilimab and
the botensilimab/balstilimab combination compared to standard of
care
- Complete enrollment of Phase 2
ACTIVATE studies of botensilimab in melanoma and pancreatic
cancer
- Expect to launch a Phase 3
confirmatory study of botensilimab/balstilimab in MSS CRC
- Continue enrollment of PD-(L)1
relapse/refractory NSCLC patients in the ongoing Phase 1b study;
design randomized phase 3 study with potential launch in 2023 if
response rates persist in expanded Phase 1b.
- Present additional data from the
botensilimab/balstilimab Phase I/II cohorts at upcoming medical
conferences, including an oral plenary session at the Society of
Gynecologic Oncology 2023 Annual Meeting in March with updated data
from the ovarian cohort.
Clinical Pipeline of Majority-Owned Assets and Strategic
Partnerships
Majority-Owned Assets:
- AGEN2373 (CD137
agonist): Currently enrolling a Phase 1b combination study
with botensilimab in PD-1 relapsed/refractory melanoma. We expect
to complete dosing of this study in the first half of 2023. The
onset of this trial triggered a milestone payment from partner
Gilead, who has an exclusive option to license AGEN2373.
- AGEN1571 (ILT2
antagonist): The first patient was dosed in a Phase 1
dose-escalating and expansion study in patients with advanced solid
tumors. The study will evaluate safety and tolerability as a single
agent and in combination with botensilimab and balstilimab.
Strategic Partnerships:
- MK-4830 (ILT4 antagonist
discovered by Agenus): Merck has initiated a randomized
Phase II study evaluating MK-4830 in combination with pembrolizumab
and chemotherapy in ovarian cancer, and two Phase I/II studies,
evaluating MK-4830 in combination with pembrolizumab and
chemotherapy or lenvatinib in advanced esophageal cancer.
Additional Phase II studies are ongoing in advanced NSCLC,
extensive stage small cell lung cancer, stage IV MSI-H colorectal
cancer, second line plus renal cell carcinoma, and stage III
melanoma.
- INCAGN2385 (LAG-3
antagonist discovered by Agenus) and INCAGN2390
(TIM-3 antagonist discovered by Agenus): Incyte launched
Phase II studies evaluating INCAGN2385 and INCAGN2390 in
combination with retifanlimab in melanoma, squamous cell carcinoma
of the head and neck, and endometrial cancer.
- INCAGN1876 (GITR agonist
discovered by Agenus): Incyte launched a Phase II study
evaluating INCAGN1876 in combination with retifanlimab in squamous
cell carcinoma of the head and neck.
- BMS-986442 (AGEN1777;
TIGIT bispecific discovered by Agenus): BMS launched a
Phase I/II study evaluating BMS-986442 in combination with
nivolumab +/- chemotherapy in patients with advanced solid tumors
and non-small cell lung cancer.
- UGN-301 (zalifrelimab
intravesical solution; anti-CTLA-4): UroGen launched a
Phase I study evaluating UGN-301 as monotherapy and in combination
with other agents, including UGN-201, in patients with non-muscle
invasive bladder cancer.
Additional 2023 Catalysts and Operational
Objectives:
- Complete enrollment of the Phase
1b study of AGEN2373 (anti-CD137) and botensilimab in
melanoma.
- Initiate combination cohorts of
AGEN1571 (anti-ILT2) with botensilimab and balstilimab.
- Potential income from existing
and future collaborators.
- Advance 7 existing clinical
collaborations evaluating combinations of external agents with our
PD-1 and CTLA-4 antibodies sponsored and executed by partners.
Fourth Quarter and Full Year 2022 Financial
Results:
As of December 31, 2022, we had a cash, cash equivalent and
short-term investment balance of $193 million, compared to $218
million and $307 million on September 30, 2022, and December 31,
2021, respectively. For the fourth quarter ended December 31, 2022,
we recognized revenue of $28 million and incurred a net loss of $74
million (including non-cash expenses of $33 million) or $0.24 per
share. For the year ended December 31, 2022, we recognized revenue
of $98 million and incurred a net loss of $231 million (including
non-cash expense of $96 million), or $0.78 per share. Revenue
includes revenue under our collaboration agreements, revenue
related to non-cash royalties earned, milestones received, and
revenue from Agenus owned CROs.
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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|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
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|
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|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
193,358 |
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|
$ |
306,923 |
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Three months ended December 31, |
|
Year ended December 31, |
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2022 |
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|
2021 |
|
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|
2022 |
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|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Revenues, research and development |
|
$ |
3,755 |
|
|
$ |
2,157 |
|
|
$ |
16,975 |
|
|
$ |
244,422 |
|
Revenues, non-cash royalty |
|
|
18,284 |
|
|
|
15,452 |
|
|
|
45,285 |
|
|
|
44,355 |
|
Revenues, royalty sales milestone |
|
|
- |
|
|
|
- |
|
|
|
25,250 |
|
|
|
- |
|
Revenues, other |
|
|
6,347 |
|
|
|
2,652 |
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|
|
10,514 |
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|
|
6,888 |
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Total Revenue |
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28,386 |
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|
|
20,261 |
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|
|
98,024 |
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|
295,665 |
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|
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|
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|
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|
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|
|
|
|
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Research and development expenses |
|
|
53,279 |
|
|
|
53,486 |
|
|
|
186,691 |
|
|
|
178,608 |
|
General and administrative expenses |
|
|
25,036 |
|
|
|
21,971 |
|
|
|
81,007 |
|
|
|
76,359 |
|
Cost of service revenue |
|
|
7,693 |
|
|
|
881 |
|
|
|
10,568 |
|
|
|
3,470 |
|
Other income |
|
|
(3,918 |
) |
|
|
(2,744 |
) |
|
|
(10,944 |
) |
|
|
(3,951 |
) |
Non-cash interest expense |
|
|
18,326 |
|
|
|
16,324 |
|
|
|
62,955 |
|
|
|
64,619 |
|
(Gain) loss related to debt |
|
|
1,937 |
|
|
|
- |
|
|
|
(782 |
) |
|
|
(6,197 |
) |
Non-cash contingent consideration fair value adjustment |
|
135 |
|
|
|
(2,050 |
) |
|
|
(815 |
) |
|
|
11,481 |
|
Net loss |
|
$ |
(74,102 |
) |
|
$ |
(67,607 |
) |
|
$ |
(230,656 |
) |
|
$ |
(28,724 |
) |
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|
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Net loss per share attributable to Agenus Inc. common
stockholders |
$ |
(0.24 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
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Cash provided by (used in) operations |
$ |
(47,338 |
) |
|
$ |
(22,927 |
) |
|
$ |
(175,373 |
) |
|
$ |
10,145 |
|
Non-cash operating expenses |
|
$ |
32,777 |
|
|
$ |
17,743 |
|
|
$ |
95,591 |
|
|
$ |
99,164 |
|
|
|
|
|
|
|
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Conference Call
Date: March 14, 2023, 8:30am ETDial-in
numbers: 646-307-1963 (US-NY) & 800-715-9871
(Ex-US)Event ID: 2699739
Webcast
A 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/p9dyor73.
References1 Mayer et al. NEJM 20152 Grothey et al. Lancet 20133
Chen et al. JAMA Oncol. 20204 Overman et al. ASCO 20165
https://clinicaltrials.gov/ct2/show/results/NCT019283946 Hinchcliff
et al. Gynecologic Oncology 20217 D’Angelo et al. Lancet Oncology
20188 Somaiah et al. Lancet Oncology 20229
https://clinicaltrials.gov/ct2/show/results/NCT0275051410 Fisher et
al. ASCO 2019
About Botensilimab
Botensilimab is a novel, multifunctional CTLA-4 investigational
antibody that has been designed to extend clinical benefits to
“cold” and refractory tumors that do not respond to standard of
care or investigational therapies. In addition to binding to the
CTLA-4 receptor, its Fc enhanced structure induces a memory immune
response, downregulates regulatory T cells, and delivers better
priming and activation of T cells, thereby amplifying immune
responses.
In a Phase 1b clinical study of more than 300 patients,
botensilimab has demonstrated clinical responses in nine solid
tumor cancers, either alone or in combination with Agenus’ PD-1
antibody, balstilimab. Agenus is conducting global, randomized
Phase 2 trials in microsatellite-stable colorectal cancer (MSS
CRC), pancreatic cancer, and melanoma as part of its ACTIVATE trial
program. A global Phase 3 trial in MSS CRC is expected to launch in
2023.
About Agenus
Agenus 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.Zack ArmenHead of Investor
Relations917-362-1370zack.armen@agenusbio.com
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