Agenus Corporate Update and Second Quarter 2021 Financial Report
August 09 2021 - 7:45AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of checkpoint antibodies, cell therapies,
adjuvants, and vaccines designed to activate immune response to
cancers and infections, today provided a corporate update and
reported financial results for the second quarter of 2021.
“In the first half of this year, we announced a collaboration
with BMS and advanced our flagship clinical candidate AGEN1181 to
an important data inflection point,” said Garo Armen, PhD, Chairman
and Chief Executive Officer of Agenus. “In the second half, we will
disclose this data at a key cancer conference and be ready with our
commercial platform in preparation for a balstilimab launch.”
AGEN1181 (Fc-enhanced anti-CTLA-4): Clinical data
support superior activity in difficult-to-treat
cancers
- Updated clinical data for AGEN1181 alone and in combination
with balstilimab will be presented at an upcoming conference.
- Clinical responses seen in patients refractory to approved
immunotherapies, including patients with microsatellite stable
(MSS) tumors and melanoma, endometrial, and ovarian cancer with the
low-affinity FcyRIIIA allele. No immune mediated hypophysitis,
pneumonitis, or hepatitis (typically seen with first generation
anti-CTLA-4s) were reported.
- Registrational trials targeted to commence by year-end 2021
with a focus on rapid path to Biologics License Application (BLA)
submission.
MiNK Therapeutics: Allogeneic iNKT cell therapy company
advances towards IPO
- MiNK Therapeutics (currently an Agenus company) filed a
confidential S-1 to support a planned Initial Public Offering
(IPO).
- Phase 1 trial of AGENT-797 in hematologic cancers dose cohorts
completed with data readouts planned in the second half of 2021;
Phase 1/2 expansion trials in viral acute respiratory distress
syndrome (ARDS) are underway.
AGEN1777 (Fc-enhanced anti-TIGIT bispecific):
Collaboration with BMS provides additional cash resources to
advance Agenus’ high value drivers
- Global exclusive license with Bristol Myers Squibb for AGEN1777
provides $200 million upfront cash. In addition, Agenus to receive
up to $1.36 billion in development, regulatory, and commercial
milestones, and tiered double-digit royalties upon product
sales.
- FDA cleared Investigational New Drug (IND) application; Phase 1
dosing with AGEN1777 alone and in combination with an anti-PD-1 in
advanced solid tumors planned to begin this quarter.
Balstilimab (anti-PD-1): BLA accepted for Priority
Review by U.S. FDA; data updates presented at ASCO
- Balstilimab BLA accepted for Priority Review by the U.S. Food
and Drug Administration (FDA) with a Prescription Drug User Fee Act
(PDUFA) target action date of December 16, 2021.
- Commercial preparation underway for a highly efficient,
targeted launch to provide broad product access to physicians and
patients while laying the foundation for future Agenus
products.
- Clinical data presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting:
- Phase 2 data for balstilimab showed a response rate of 20% in
PD-L1 positive tumors, overall response rate of 15%, and median
duration of response of 15.4 months.
- Balstilimab showed superior tumor killing compared to approved
anti-PD-1s such as pembrolizumab and nivolumab.
- Results from a Phase 2 trial of balstilimab plus zalifrelimab
combination in recurrent or metastatic cervical cancer to be
presented in a Mini Oral Session at the European Society for
Medical Oncology (ESMO) Congress 2021 on September 19 from 11:35 –
11:40am ET.
Additional programs
- Phase 1 data for AGEN2373, a CD137
agonist antibody, in patients with advanced solid tumors were
presented at ASCO 2021.
- No dose limiting toxicities were
seen at doses up to 3 mg/kg, including no liver toxicity.
Combination trials are in planning.
- Process for scale up of QS-21
manufacturing continues to advance.
- VISION platform knowledge base expanding to support AGEN1181
response prediction and combination discovery.
Management appointments
- Steven O’Day, MD appointed to Chief Medical Officer.
- Andy Hurley appointed to Chief Commercial Officer.
- Marc Wiles, PhD appointed to Vice President of Regulatory
Affairs.
- Julie DeSander promoted to Chief Business Officer.
- Joseph Grossman, MD, appointed to Vice President of Exploratory
Medicine.
- Jason Paragas appointed to Vice President of Data
Sciences.
- Jennifer Buell, PhD, appointed to Chief Executive Officer of
MiNK Therapeutics. Dr. Buell will continue as a member of the
Agenus Executive Committee.
Second Quarter Financial Results
We ended the second quarter of 2021 with a cash balance of $74
million as compared to $100 million at December 31, 2020.
Subsequent to the quarter end we received $200 million related to
our BMS partnership.
For the second quarter ended June 30, 2021, our cash used in
operations was $56 million and we reported a net loss of $84
million or $0.37 per share which included a number of non-cash
items. This compares to cash used in operations for the same period
in 2020 of $37 million and a net loss of $48 million or $0.28 per
share. Non-cash operating expenses for the second quarter ended
June 30, 2021 were $30 million compared to $18 million for the
second quarter of 2020.
Our cash used in operations for the six months ended June 30,
2021 was $98 million with a net loss of $138 million or $0.65 per
share compared to cash used in operations of $72 million and a net
loss for the same period in 2020 of $94 million or $0.59 per
share.
We recognized revenue of $22 million and $42 million for the
six-months ended June 30, 2021 and 2020, respectively, which
includes revenue related to non-cash royalties earned, revenue
recognized under our collaboration agreements, and in 2020, $14
million from an upfront license fee received.
Select
Financial Information |
(in thousands,
except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
73,543 |
|
* |
$ |
99,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*Excludes $200 million received in July 2021 from
BMS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30, |
|
Six months ended
June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Revenues,
research and development |
|
$ |
1,708 |
|
|
$ |
18,068 |
|
|
$ |
3,279 |
|
|
$ |
19,996 |
|
Revenues,
non-cash royalty |
|
|
7,826 |
|
|
|
7,846 |
|
|
|
16,310 |
|
|
|
21,002 |
|
Revenues,
other |
|
|
1,196 |
|
|
|
1,031 |
|
|
|
2,860 |
|
|
|
1,075 |
|
Total Revenue |
|
|
10,730 |
|
|
|
26,945 |
|
|
|
22,449 |
|
|
|
42,073 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses |
|
|
45,508 |
|
|
|
38,550 |
|
|
|
82,184 |
|
|
|
74,913 |
|
General and
administrative expenses |
|
|
16,650 |
|
|
|
14,195 |
|
|
|
33,003 |
|
|
|
24,809 |
|
Cost of
service revenue |
|
|
667 |
|
|
|
634 |
|
|
|
1,772 |
|
|
|
634 |
|
Other
expense (income) |
|
|
1,210 |
|
|
|
623 |
|
|
|
(1,369 |
) |
|
|
1,865 |
|
Non-cash
interest expense |
|
|
16,386 |
|
|
|
14,347 |
|
|
|
31,997 |
|
|
|
28,191 |
|
Loss on
modification of debt |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,720 |
|
Non-cash contingent consideration fair value adjustment |
|
14,300 |
|
|
|
6,840 |
|
|
|
13,256 |
|
|
|
2,456 |
|
Net
loss |
|
$ |
(83,991 |
) |
|
$ |
(48,244 |
) |
|
$ |
(138,394 |
) |
|
$ |
(93,515 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share attributable to Agenus Inc. common
stockholders |
$ |
(0.37 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.59 |
) |
|
|
|
|
|
|
|
|
|
Cash
used in operations |
|
$ |
(55,557 |
) |
|
$ |
(37,375 |
) |
|
$ |
(98,301 |
) |
|
$ |
(71,880 |
) |
Non-cash
operating expenses |
|
$ |
30,171 |
|
|
$ |
17,685 |
|
|
$ |
41,984 |
|
|
$ |
20,806 |
|
|
|
|
|
|
|
|
|
|
Conference CallMonday August 9, 2021, 8:30am
ETDial-in numbers: (833) 614-1394 (US) or (914) 987-7115
(International).Conference ID number: 3686849.
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/gsbikqz2.
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 MiNK Therapeutics subsidiary), 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 regarding clinical development and regulatory plans and
timelines, anticipated corporate milestones, new clinical data and
program updates to be presented, and the anticipated commercial
launch of balstilimab. 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 Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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