Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today reported
business highlights and financial results for the fourth quarter
and full year 2021.
“2021 was a year of tremendous accomplishment for Caribou as we
completed our successful IPO, advanced our pipeline of allogeneic
CAR-T and CAR-NK cell therapies, including the initiation of the
ANTLER Phase 1 clinical trial for our lead program CB-010, and
expanded our leadership team,” said Rachel Haurwitz, Ph.D.,
Caribou’s president and chief executive officer. “These
achievements put us in a great position to execute on our 2022
plans to present initial data from the ANTLER clinical trial for
CB-010 at a medical meeting; submit an IND for CB-011, our second
allogeneic CAR-T cell program; and share target selection for
CB-020, our first genome-edited CAR-NK cell therapy. We believe our
chRDNA genome-editing platform has superior specificity and has the
potential to be applied across a broad number of therapeutic
applications, in oncology and beyond.”
Recent Business Highlights
Pipeline
- Caribou continues to enroll patients in ANTLER, a Phase 1
clinical trial of CB-010 in adults with relapsed or refractory B
cell non-Hodgkin lymphoma (r/r B-NHL). CB-010 is an allogeneic
anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid
RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the
TRAC gene and knock out PD-1 to boost the persistence of antitumor
activity. More information can be found at www.clinicaltrials.gov
(NCT04637763).
- Caribou is conducting IND-enabling studies to support a planned
IND application submission in 2022 for CB-011 in patients with
relapsed or refractory multiple myeloma (r/r MM). CB-011 is an
allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a
chRDNA technology to insert a BCMA-specific CAR into the TRAC gene
and armor the cells with an immune cloaking strategy that includes
a knockout of the endogenous B2M gene and site-specific insertion
of a B2M–HLA-E fusion transgene into the B2M gene.
Expanded leadership team
- In January 2022, Caribou appointed Syed Rizvi, M.D., as chief
medical officer. Dr. Rizvi has more than two decades of experience
in all stages of drug development, from clinical strategy and
execution through regulatory submissions to support approval and
commercialization of several cancer treatments, including three
approved autologous CAR-T cell therapies ABECMA®, BREYANZI®, and
CARVYKTI™. Prior to joining Caribou, Dr. Rizvi served as chief
medical officer of Chimeric Therapeutics and worked for Legend
Biotech, Celgene Corporation (now Bristol Myers Squibb), Novartis,
Merck, and Genta, Inc. Since the beginning of 2021, Caribou has
welcomed three new members of the executive leadership team. In
addition to Dr. Rizvi, Ruhi Khan joined as chief business officer,
and Jason O’Byrne joined as chief financial officer.
- In January 2022, Zili An, M.D., joined Caribou as Vice
President of Pharmacology. He brings over 20 years of drug
development experience in multiple cancer therapeutic modalities,
including CAR-T cell therapies.
- During 2021, Caribou expanded its board of directors, which
currently includes Andrew Guggenhime (board chair), Scott
Braunstein, M.D., Rachel Haurwitz, Ph.D., Dara Richardson-Heron,
M.D., Natalie Sacks, M.D., Nancy Whiting, Pharm.D., and Ran Zheng.
Caribou’s directors bring significant and broad expertise in
strategy, drug development, operations, and patient need.
- In 2021, two new members joined the Caribou’s scientific
advisory board, Katy Rezvani, M.D., Ph.D., and Christopher
Sturgeon, Ph.D., both of whom bring significant expertise in the
development and role of natural killer (NK) cells in mediating
immunity against hematologic and solid tumors.
Anticipated Milestones for 2022 and Beyond
- CB-010: Caribou expects to present initial data from its
ongoing ANTLER Phase 1 trial for CB-010, an anti-CD19 CAR-T cell
therapy, in adults with r/r B-NHL at a medical meeting in
2022.
- CB-011: Caribou expects to submit an IND application for
CB-011, an anti-BCMA CAR-T cell therapy, in r/r MM in 2022.
- CB-020: Caribou expects to announce target selection for
CB-020, an iPSC-derived CAR-NK cell therapy in 2022. Additionally,
Caribou expects to disclose multiple armoring strategies under
development for its CAR-NK platform in 2022.
- CB-012: Caribou expects to submit an IND application for
CB-012, an anti-CD371 CAR-T cell therapy for r/r AML, in 2023.
Upcoming Meetings
- American Association for Cancer Research (AACR) Annual Meeting
– April 10, 2022, presentation of preclinical data from Caribou’s
CB-011 program
- Cell & Gene Meeting on the Med – April 20-22, 2022,
corporate overview
- Allogeneic Cell Therapies Summit – May 9-12, 2022, Caribou
scientists will provide an overview of the company’s T cell
programs
Fourth Quarter and Full Year 2021 Financial
Results
Cash, cash equivalents, and marketable
securities: Caribou had $413.5 million in cash, cash
equivalents, and marketable securities as of December 31, 2021,
which included $321.0 million in aggregate net proceeds from the
company’s IPO completed in July and August 2021. Additional funding
during 2021 came from the Series C financing completed in March
2021 and an upfront payment from Caribou’s collaboration and
license agreement with AbbVie in February 2021.
Licensing and collaboration revenue: Revenue
from Caribou’s licensing and collaboration agreements was $2.6
million for the three months ended December 31, 2021 and $9.6
million for the full year 2021, compared to $1.0 million and $12.4
million, respectively, for the same periods in 2020. The decrease
for the year ended December 31, 2021, was primarily due to revenue
recognized in 2020 pursuant to an exclusive license agreement
between Caribou and a private company, partially offset by an
increase in revenue recognized in 2021 pursuant to the AbbVie
agreement.
R&D expenses: Research and development
expenses were $15.1 million for the three months ended December 31,
2021, and $52.3 million for the full year 2021, compared to $12.0
million and $34.4 million, respectively, for the same periods in
2020. The increase for the year ended December 31, 2021, was
primarily due to costs associated with clinical trial and
preclinical study activities, personnel-related expenses
attributable to increased headcount, and facilities expenses,
partially offset by a decrease in expenses related to licenses and
sublicensing revenues.
G&A expenses: General and
administrative expenses were $7.9 million for the three months
ended December 31, 2021, and $24.3 million for the full year 2021,
compared to $4.2 million and $14.1 million, respectively, for the
same periods in 2020. The increase for the year ended December 31,
2021, was primarily due to personnel-related expenses attributable
to increased headcount, legal and accounting services associated
with operating as a public company, and facilities and other
expenses.
Other income (expense): The Company recorded
other income of $2.2 million for the three months ended December
31, 2021, and $0.4 million for the full year 2021.
Net loss: For the three months and year ended
December 31, 2021, net loss was $18.5 million and $66.9 million,
respectively, compared to $14.7 million and $34.3 million,
respectively, for the same periods in 2020.
About Caribou’s Novel Next-Generation CRISPR
PlatformCRISPR genome editing uses easily designed,
modular biological tools to make DNA changes in living cells. There
are two basic components of Type II and Type V CRISPR systems: the
nuclease protein that cuts DNA and the RNA molecule(s) that guide
the nuclease to generate a site-specific, double-stranded break,
leading to an edit at the targeted genomic site. CRISPR systems
occasionally edit unintended genomic sites, known as off-target
editing, which may lead to harmful effects on cellular function and
phenotype. In response to this challenge, Caribou has developed
chRDNAs (pronounced “chardonnays”), RNA-DNA hybrid guides that
direct substantially more precise genome editing compared to
all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA
technology to carry out high efficiency multiple edits, including
multiplex gene insertions, to develop CRISPR-edited therapies.
About Caribou Biosciences, Inc.Caribou
Biosciences is a clinical-stage CRISPR genome-editing
biopharmaceutical company dedicated to developing transformative
therapies for patients with devastating diseases. The company’s
genome-editing platform, including its proprietary Cas12a chRDNA
technology, enables superior precision to develop cell therapies
that are specifically engineered for enhanced persistence. Caribou
is advancing a pipeline of off-the-shelf CAR-T and CAR-NK cell
therapies for the treatment of patients with hematologic
malignancies and solid tumors.
For more information about Caribou, visit www.cariboubio.com and
follow the company @CaribouBio.
“Caribou Biosciences” and the Caribou logo are registered
trademarks of Caribou Biosciences, Inc.
Forward-Looking StatementsThis press release
contains forward-looking statements, within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, without limitation, statements
related to Caribou’s strategy, plans and objectives, and
expectations regarding its clinical and preclinical development
programs, including its timing expectations relating to the release
of initial patient data from its ANTLER phase 1 clinical trial for
CB-010, the submission of IND applications for CB-011 and CB-012,
and target selection for CB-020. Management believes that these
forward-looking statements are reasonable as and when made.
However, such forward-looking statements are subject to risks and
uncertainties, and actual results may differ materially from any
future results expressed or implied by the forward-looking
statements. Risks and uncertainties include without limitation the
risks inherent in drug development such as those associated with
being in the early stages of our clinical development, and with the
initiation, cost, timing, progress and results of current and
future research and development programs, preclinical studies, and
clinical trials, as well as other risk factors described from time
to time in Caribou’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year
ended December 31, 2021. In light of the significant uncertainties
in these forward-looking statements, you should not rely upon
forward-looking statements as predictions of future events. Except
as required by law, Caribou undertakes no obligation to update
publicly any forward-looking statements for any reason.
Caribou Biosciences, Inc.Condensed Consolidated
Balance Sheet Data(in thousands) (unaudited)
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
Cash, cash
equivalents, and marketable securities |
$ |
413,508 |
|
$ |
15,953 |
|
|
Total
assets |
|
442,356 |
|
|
36,046 |
|
|
Total
liabilities |
|
54,531 |
|
|
18,160 |
|
|
Convertible
preferred stock |
|
— |
|
|
41,323 |
|
|
Total
stockholders' equity (deficit) |
|
387,825 |
|
|
(23,437 |
) |
|
Total
liabilities, convertible preferred stock, and stockholders' equity
(deficit) |
$ |
442,356 |
|
$ |
36,046 |
|
|
|
|
|
|
|
Caribou Biosciences, Inc.Condensed Consolidated
Statement of Operations(in thousands, except share and per share
data)(unaudited)
|
|
Three Months Ended, December 31, |
|
Years Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Licensing
and collaboration revenue |
|
$ |
2,559 |
|
|
$ |
984 |
|
|
$ |
9,598 |
|
|
$ |
12,361 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
15,111 |
|
|
|
12,024 |
|
|
|
52,255 |
|
|
|
34,425 |
|
General and administrative |
|
|
7,853 |
|
|
|
4,171 |
|
|
|
24,322 |
|
|
|
14,060 |
|
Total operating expenses |
|
|
22,964 |
|
|
|
16,195 |
|
|
|
76,577 |
|
|
|
48,485 |
|
Loss from
operations |
|
|
(20,405 |
) |
|
|
(15,211 |
) |
|
|
(66,979 |
) |
|
|
(36,124 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
76 |
|
|
|
79 |
|
|
|
148 |
|
|
|
236 |
|
Interest expense |
|
|
— |
|
|
|
(6 |
) |
|
|
(8 |
) |
|
|
(20 |
) |
Change in fair value of equity securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(733 |
) |
Change in fair value of the MSKCC success payments liability |
|
|
2,158 |
|
|
|
— |
|
|
|
(1,426 |
) |
|
|
— |
|
Gain on extinguishment of PPP loan |
|
|
— |
|
|
|
— |
|
|
|
1,584 |
|
|
|
— |
|
Other income |
|
|
13 |
|
|
|
81 |
|
|
|
79 |
|
|
|
514 |
|
Total other income (expense) |
|
|
2,247 |
|
|
|
154 |
|
|
|
377 |
|
|
|
(3 |
) |
Net loss
before provision for (benefit from) income taxes |
|
|
(18,158 |
) |
|
|
(15,057 |
) |
|
|
(66,602 |
) |
|
|
(36,127 |
) |
Provision for (benefit from) income taxes |
|
|
321 |
|
|
|
(354 |
) |
|
|
321 |
|
|
|
(1,819 |
) |
Net
loss |
|
$ |
(18,479 |
) |
|
$ |
(14,703 |
) |
|
$ |
(66,923 |
) |
|
$ |
(34,308 |
) |
Net loss per
share, basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(1.68 |
) |
|
$ |
(2.11 |
) |
|
$ |
(4.01 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
60,180,759 |
|
|
|
8,775,242 |
|
|
|
31,663,243 |
|
|
|
8,546,741 |
|
|
|
|
|
|
|
|
|
|
Caribou
Biosciences, Inc. Contacts: |
Amy Figueroa,
CFA |
Investor Relations
and Corporate Communications |
afigueroa@cariboubio.com |
|
Investors: |
Elizabeth Wolffe,
Ph.D., and Sylvia Wheeler |
Wheelhouse LSA |
lwolffe@wheelhouselsa.com |
swheeler@wheelhouselsa.com |
|
Media: |
Greg Kelley |
Ogilvy |
gregory.kelley@ogilvy.com |
617-461-4023 |
|
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