Conference Call on Tuesday, November 7, 2023,
at 9:00 a.m. ET
Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering
and developing novel immunological agents to treat various cancers,
today announced results for the third quarter 2023. Agenus
executives will host a conference call and webcast at 9:00 a.m. ET
to discuss the results and to provide a corporate update.
Key highlights include:
- Recent data shows that botensilimab (BOT), with or without
balstilimab (BAL), is broadly effective in treating five advanced
solid tumors: colorectal, pancreatic, lung, melanoma, and
sarcoma.
- Over the past 12 months, clinical data on BOT/BAL has been
featured in six oral or plenary sessions at major cancer
conferences and published in peer-reviewed medical and scientific
journals.
- Considering the poor treatment alternatives for patients with
advanced colorectal cancer (CRC) and the promising, long-lasting
benefits of BOT/BAL, a Biologics License Application (BLA) is
anticipated for submission to the U.S. Food & Drug
Administration (FDA) for microsatellite stable (MSS) metastatic CRC
in mid-2024.
- Enrollment for the ACTIVATE-CRC Phase 2 Trial is complete; data
readouts for the ACTIVATE-Pancreatic, ACTIVATE-Melanoma, and the
Phase 1b trial in non-small cell lung cancer (NSCLC) are expected
throughout 2024.
"The botensilimab franchise, after treating more than 750
patients, has demonstrated consistent tumor responses across a
diverse range of nine tumor types, showcasing its potential for
significant impact in oncology," said Chief Executive Officer, Garo
Armen, Ph.D. "The emerging data indicating the efficacy of
botensilimab in earlier stages of cancer marks a notable shift
towards less invasive treatment options. Agenus is forging ahead
with a focus on our regulatory filing in CRC, advancing our robust
clinical pipeline, and committing to deliver substantial outcomes
for patients and create value for our shareholders."
New and Updated Botensilimab Data at Corporate Event During
ESMO 2023
Microsatellite Stable Colorectal Cancer (MSS CRC)
Patients:
- In an analysis of 70 patients evaluable for efficacy, those
without active liver metastases exhibited a confirmed response rate
(ORR) of 24%, significantly surpassing the 2.8% achieved with
standard of care (SOC). 1
- These patients demonstrated a 12-month overall survival (OS)
rate of 74%, with median OS not yet reached, compared to a
12.9-month benchmark with 1, with a median follow-up of 12.3
months.
Based on the totality of the evidence from the Phase 1 and Phase
2 trials, Agenus plans to submit its BLA to the U.S. FDA for
BOT/BAL in patients with 2/3L+ MSS CRC in mid-2024 and an EU
marketing authorization filing in 2025. Interactions with
regulatory agencies are ongoing.
Neoadjuvant CRC*:
- Treatment with one dose of BOT and two doses of BAL resulted in
considerable tumor size reduction within approximately four weeks
prior to surgery.
- All three patients with MSI-H CRC experienced major
pathological responses (>90%), while 67% (6/9) of MSS CRC
patients who don’t normally respond to other Immuno-oncology (IO)
treatments, had responses 50% or greater, including two complete
responses.
- Agenus plans to prioritize neoadjuvant development and is
evaluating study designs for potential registration.
2L Metastatic Pancreatic:
- In FOLFIRINOX relapsed/refractory (2L) metastatic pancreatic
cancer patients, all of whom had liver metastases, 4 of 6
experienced marked tumor marker reductions associated with ongoing
tumor reductions when treated with gemcitabine-Abraxane in
combination with botensilimab.
- A Phase 2 randomized study is in progress, with an update
expected in the first half of 2024 and a possible supplemental BLA
filing in 2025.
2L+ CTLA-4/PD-1 Relapsed Refractory Advanced
Melanoma:
- Phase 1b expansion cohort in advanced melanoma reported a 30%
ORR and 60% disease control rate; all patients had failed anti-PD-1
therapy and 8/10 had failed both anti-PD-1/CTLA-4 therapy.
- The Phase 2 results are expected in the second half of 2024,
with the BOT monotherapy arm fully enrolled, and approximately 30
patients in the BOT/BAL combination arm. We are currently defining
strategies for the rapid enrollment of BOT in melanoma patients who
are refractory to current IO treatments and expect to pursue rapid
registration strategies in 2024.
Refractory NSCLC:
- In the PD(L)-1 refractory cohort, a 56% ORR and an 89% disease
control rate were observed in patients treated with the BOT/BAL
combination (n=9).
- In the EGFR mutation refractory cohort, two objective responses
were observed with one patient experiencing a -90% tumor reduction
at 12 weeks.
- Phase 1b results are expected in mid-2024, with approximately
50 patients enrolled. With the data generated, we are in the
process of designing trials to support rapid approval in patients
that are refractory to PD-1, as well as cohorts of patients with
mutations, who have no viable treatment options.
Advanced Sarcomas:
- Updated findings from a Phase 1b study of 41 efficacy evaluable
patients presented at ESMO 2023 showed continued efficacy, with an
ORR of 20%, a median response duration of 19.4 months (iRECIST),
and a 6-month progression-free survival rate of 40%.
- A higher ORR was observed by dose level, with 29% at 2 mg/kg
BOT compared to 15% at 1 mg/kg BOT.
Corporate Partnership Progress:
BMS-986442 (AGEN1777) – An Fc-Enhanced TIGIT Bispecific:
Bristol Myers Squibb's BMS-986442, originally developed by
Agenus and known as AGEN1777, is a bispecific antagonist targeting
both TIGIT and CD96. This therapeutic is designed to augment
tumor-reactive T cell activity through its Fc-enhanced region.
Following the licensing agreement in 2021, the phase 1 study in
solid tumors concluded successfully. Currently, a phase 2 dose
expansion study is underway, assessing BMS-986442 in combination
with nivolumab, with or without chemotherapy. The screening for
this phase commenced on October 13, 2023, and dosing of the first
phase 2 patient is scheduled for November, which will result in a
milestone payment for Agenus.
Third Quarter 2023 Financial
Overview:
Given the current environment in the biotech sector and our
financial resource needs to drive our objectives, we have taken and
will continue to take steps to contain our costs. We are actively
pursuing immediate prospects for additional cash infusion that
don’t involve stock issuances, including a milestone payment from
one of our partnered programs, expected by the end of 2023. In
addition to this expected milestone, we are in the process of
selling two non-strategic assets and the partial sale of other
milestones and royalties due to Agenus from our partnered programs.
These three sales are expected to close by the end of the first
half of 2024. With our end of third quarter cash, cash equivalent,
and short-term investment balance of $106.3 million, along with
these four planned transactions, we believe we are sufficiently
funded through the end of 2024. In addition to these planned
transactions, we are also in advanced discussions for a potential
structured financing for BOT/BAL as well as a potential corporate
collaboration with a large pharma or biotech company.
The third quarter 2023 closed with a consolidated cash, cash
equivalent and short-term investment balance of $106.3 million,
compared to $193.4 million at on December 31, 2022.
For the three and nine months ended September 30, 2023, we
recognized revenue, which includes non-cash revenue, of $24.3
million and $72.5 million, respectively. Including non-cash
expenses of $28.1 million, we incurred a net loss of $64.5 million
for the third quarter. For the nine months of 2023, we incurred a
net loss of $208.9 million including non-cash expenses of $82
million.
Select Financial Information (in thousands, except per share
data) (unaudited)
September 30, 2023
December 31, 2022
Cash, cash equivalents and short-term investments
$
106,305
$
193,358
Three months ended September
30,
Nine months ended September
30,
2023
2022
2023
2022
Revenues, royalty sales milestone
$
-
$
7,934
$
-
$
25,250
Revenues, non-cash royalty
20,360
9,224
61,534
27,001
Revenues, research and development
3,414
4,573
8,515
13,220
Revenues, other
540
1,041
2,464
4,167
Total Revenue
24,314
22,772
72,513
69,638
Research and development expenses
51,443
46,011
167,846
133,412
General and administrative expenses
18,909
18,105
57,562
55,971
Cost of service revenue
303
308
2,851
2,875
Other income
(866
)
(971
)
(2,470
)
(9,745
)
Non-cash interest expense
19,057
16,041
55,977
44,629
Non-cash contingent consideration fair value adjustment
-
(7
)
(398
)
(950
)
Net loss*
$
(64,532
)
$
(56,715
)
$
(208,855
)
$
(156,554
)
Net loss per share attributable to Agenus Inc. common
stockholders
$
(0.16
)
$
(0.19
)
$
(0.57
)
$
(0.54
)
Conference Call
To access dial-in numbers, please register here.
Conference ID: 73242
Webcast
A 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://events.q4inc.com/attendee/357374738.
References
1. Cohen et al. ASCO Annual Meeting 2023
*Investigator Sponsored Trial (IST)
About Botensilimab
Botensilimab is an investigational multifunctional anti-CTLA-4
immune activator (antibody) designed to boost both innate and
adaptive anti-tumor immune responses. Its novel design leverages
mechanisms of action to extend immunotherapy benefits to "cold"
tumors which generally respond poorly to standard of care or are
refractory to conventional PD-1/CTLA-4 therapies and
investigational therapies. Botensilimab augments immune responses
across a wide range of tumor types by priming and activating T
cells, downregulating intratumoral regulatory T cells, activating
myeloid cells and inducing long-term memory responses.
Approximately 750 patients have been treated with botensilimab
in phase 1 and phase 2 clinical trials. Botensilimab alone, or in
combination with Agenus’ investigational 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 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 @agenus_bio.
Information that may be important to investors will be routinely
posted on our website and social media channels.
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 regarding a its botensilimab
and balstilimab programs, expected regulatory timelines and
filings, 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 Annual Report on
Form 10-K for 2022, and subsequent Quarterly Reports on Form 10-Q
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.
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Investor Contact
917-362-1370 investor@agenusbio.com
Media Contact 781-674-4784
communications@agenusbio.com
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