Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing
novel immunological agents to treat various cancers, today
announced results for the second quarter 2023.
Key accomplishments and highlights include:
- Botensilimab Update: Botensilimab/balstilimab
combination data presented at ESMO-GI demonstrated median overall
survival (mOS) of 20.9 months and a 23% overall response rate
(ORR), both surpassing data reported for standard of care in 3L+
Non-MSI-H colorectal cancer (CRC) in patients without active liver
metastases.
- Regulatory: The U.S. FDA granted Fast Track designation
for the botensilimab/balstilimab combination in 3L+ Non-MSI-H CRC
in patients without active liver metastases. Agenus is exploring
global accelerated approval strategies for CRC.
- Clinical Trial Progress: Ongoing Phase 2 ACTIVATE trials
in CRC and melanoma expected to fully enroll by end of year.
- AGEN2373 Update: AGEN2373 Phase 1 dose escalation data
presented at ASCO demonstrated promising monotherapy clinical
responses in patients with advanced solid tumors.
“Botensilimab, alone or in combination with balstilimab,
continues to display remarkable clinical activity in over 600
patients treated across nine late-stage, treatment resistant solid
tumor cancers, demonstrating great potential to revolutionize the
role of immunotherapy in cancer treatment,” said Chief Executive
Officer, Garo Armen, Ph.D. “Agenus is committed to advancing our
diverse clinical pipeline with a focus on expediting our first
regulatory submission for the botensilimab/balstilimab combination
in colorectal cancer. Our data has demonstrated an unprecedented
survival benefit over what has been reported for standard of care,
underscoring this combination as an important potential treatment
option for patients with non-MSI-high colorectal cancer, which
represents 85% of the population of patients with colorectal
cancer1.”
Botensilimab/Balstilimab (“Bot/Bal”) Combination in 3L+
Non-MSI-H Metastatic CRC Data Presented at the ESMO-GI World
Congress on Gastrointestinal Cancer in June 2023:
- In 69 evaluable patients with non-MSI-High CRC without active
liver metastases, results demonstrated a meaningful improvement
over standard of care in both overall response rate (ORR%) and
median overall survival (mOS):
- mOS of 20.9 months as compared to the recently reported
12.9-month benchmark with standard care.2
- ORR of 23% as compared to the recently reported 2.8%1 benchmark
with standard care.
- In April 2023, the U.S. FDA granted Fast Track designation to
the bot/bal combination for patients with non-MSI-H/dMMR metastatic
CRC without active liver metastases.
- The ACTIVATE Phase 2 trial in this patient population is on
target to conclude enrollment by year-end. Planning is underway for
a Phase 3 CRC study; with Fast Track designation from the FDA,
study design and timing will be determined as we discuss our filing
approach with the agency.
- A Biologics License Application to the FDA is planned in
2024.
Botensilimab in Other Advanced Solid Tumor Cancers:
- Lung: Enrollment continues for a Phase 1b trial targeting
PD-(L)1 +/- chemotherapy relapsed/refractory non-small-cell lung
cancer (NSCLC); data update planned by year-end.
- Melanoma: Ongoing global enrollment in Phase 2 ACTIVATE trial
with data update planned in 2024.
- Ovarian: Phase 1b trial in patients with platinum-resistant
ovarian cancer (PROC) demonstrated a 33% ORR and 67% disease
control rate among primarily high-grade, heavily pretreated
patients (presented at SGO in March 2023).
- Sarcomas: Updated data for a Phase 1b cohort with advanced
sarcomas to be presented at ESMO on October 21st 2023.
AGEN2373 Data Presented at the ASCO 2023 Annual
Meeting:
- Complete results from the first-in-human monotherapy dose
escalation study of AGEN2373, a CD137 agonist, in patients with
advanced solid tumors:
- Reported responses in metastatic prostate cancer, ampullary
carcinoma, and vulvar squamous cell carcinoma highlight the
potential impact of AGEN2373.
- AGEN2373 is the first CD137 agonist antibody to report
single-agent responses with no major toxicities.
- Clinical data are consistent with mechanistic design intent of
AGEN2373 to avoid hepatic toxicity, a typical constraint of
CD137-targeted agonists.
Leadership Appointments:
In alignment with Agenus' next phase of growth and anticipated
commercialization of the bot/bal combination, the company announced
the following key executive appointments:
- Robin Taylor, Ph.D., Chief Commercial Officer.
- Homa Yeganegi, Chief Product Strategy and Global Medical
Affairs Officer.
- Stephanie Fagan, Chief Communications Officer.
Second Quarter 2023 Financial Results:
We ended our second quarter 2023 with a cash, cash equivalent
and short-term investment balance of $157.6 million, compared to
$193.4 million at December 31, 2022. In addition, we have raised
$20.3 million through sales of our common stock under our at market
issuance sales agreement since the end of Q2 2023.
For the three and six months ended June 30, 2023, we recognized
revenue of $25.3 million and $48.2 million and incurred a net loss
of $73.4 million and $144.3 million, respectively. Our net loss
includes non-cash expenses of $28.9 million for the three months
ended, and $53.8 million for the six months ended, June 30,
2023.
Select Financial Information (in thousands, except per share
data) (unaudited) June 30, 2023 December 31, 2022
Cash, cash equivalents and short-term investments
$
157,852
$
193,358
Cash raised since quarter end
$
20,281
Three months ended June 30, Six months ended June 30,
2023
2022
2023
2022
Revenues, royalty sales milestone
$
-
$
17,316
$
-
$
17,316
Revenues, non-cash royalty
22,068
144
41,174
17,778
Revenues, research and development
2,489
1,907
5,101
8,647
Revenues, other
739
1,559
1,923
3,126
Total Revenue
25,296
20,926
48,198
46,867
Research and development expenses
59,285
44,960
116,402
87,404
General and administrative expenses
20,415
18,914
38,653
37,866
Cost of service revenue
254
2,024
2,548
2,567
Other income
(883
)
(8,966
)
(1,604
)
(8,776
)
Non-cash interest expense
19,647
13,636
36,920
28,588
Non-cash contingent consideration fair value adjustment
8
(407
)
(398
)
(943
)
Net loss*
$
(73,430
)
$
(49,235
)
$
(144,323
)
$
(99,839
)
Net loss per share attributable to Agenus Inc. common
stockholders:
$
(0.20
)
$
(0.17
)
$
(0.41
)
$
(0.35
)
*Includes non-cash expenses Adjusted Net loss for non-cash
expenses: Net loss as reported
$
(73,430
)
$
(49,235
)
$
(144,323
)
$
(99,839
)
Non-cash expenses Depreciation and amortization
2,973
1,690
5,535
3,350
Share based compensation
6,042
4,634
11,527
9,625
Non-cash interest expense
19,647
13,636
36,920
28,588
Other
285
(409
)
(100
)
(943
)
Total non-cash expenses
28,947
19,551
53,882
40,620
Net loss excluding non-cash expenses
$
(44,483
)
$
(29,684
)
$
(90,441
)
$
(59,219
)
References
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3037515/ 2 Cohen
et al. ASCO Annual Meeting 2023
About Botensilimab
Botensilimab, an investigational multifunctional CTLA-4
antibody, is designed to extend immunotherapy benefits to “cold”
tumors, which have not historically responded to standard of care
or other investigational therapies. Besides binding to the CTLA-4
receptor, its Fc-enhanced structure induces a memory immune
response, downregulates regulatory T cells, and activates T cells,
thereby enhancing immune responses. Approximately 600 patients have
been treated with botensilimab in phase 1 and phase 2 clinical
trials. Botensilimab alone, or in combination with Agenus’ PD-1
antibody, balstilimab, has shown clinical responses across nine
metastatic, late-line cancers. For more information about
botensilimab trials, visit www.clinicaltrials.gov with the
identifiers NCT03860272, NCT05608044, NCT05630183, and
NCT05529316.
About AGEN2373
AGEN2373 is a novel anti-CD137 agonist that has been designed to
activate T and NK cells while mitigating liver toxicities common to
the CD137 target class. CD137 (4-1BB) is an activating receptor
expressed on T and NK cells. Upon binding to CD137, AGEN2373 is
designed to stimulate the growth and activation of cytotoxic T and
NK cells, triggering a lasting memory response to cancer. AGEN2373
binds to a unique epitope designed to achieve this response
specifically within the tumor microenvironment. This selective
binding is designed to avoid serious side effects associated with
CD137 activation in the liver that have been reported by competitor
molecules. AGEN2373 has demonstrated preliminary clinical activity
and has been well tolerated by patients without signs of liver
toxicity (Barve et al. ASCO 2023).
About Agenus
Agenus is a leading immuno-oncology company targeting cancer and
infectious diseases with a comprehensive pipeline of immunological
agents. The company’s mission is to expand patient populations
benefiting from cancer immunotherapy through combination
approaches, using a broad repertoire of antibody therapeutics,
adoptive cell therapies (through MiNK Therapeutics) and adjuvants
(through SaponiQx). Agenus is headquartered in Lexington, MA. For
more information, visit www.agenusbio.com or follow us on LinkedIn
and Twitter @agenus_bio.
Non-GAAP Financial Measures
To supplement our financial disclosures that are prepared and
presented in accordance with generally accepted accounting
principles in the United States (“GAAP”), this press release
includes Adjusted Net Loss, which is a non-GAAP financial measure
that we believe is helpful to our investors. We use these non-GAAP
financial measures for financial and operational decision-making
purposes. We believe these measures provide investors with
meaningful period-to-period comparisons of our underlying
performance.
Adjusted Net Loss is a supplemental measure of our operating
performance and excludes the impacts of certain costs required to
be recorded under GAAP. We calculate Adjusted Net Loss as net loss
adjusted to exclude non-cash expenses of depreciation and
amortization, share based compensation, non-cash interest expense
and certain other non-cash expenses. Accordingly, Adjusted Net Loss
should not be considered in isolation or as a substitute for net
loss, which is the most directly comparable financial measure
presented in accordance with GAAP.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230808427181/en/
Investor Contact
917-362-1370 investors@agenusbio.com
Media Contact 781-674-4784
communications@agenusbio.com
Agenus (NASDAQ:AGEN)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Agenus (NASDAQ:AGEN)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024