Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today reported
financial results for the first quarter of 2022 and provided
business updates.
“Building on the momentum and significant achievements of 2021,
we focused on execution and the advancement of our pipeline of
genome-edited allogeneic CAR-T and CAR-NK cell therapies in the
first quarter of 2022,” said Rachel Haurwitz, Ph.D., Caribou’s
president and chief executive officer. “We continue to enroll
patients in our ANTLER Phase 1 clinical trial of CB-010 and we are
slated to share initial data from patients with relapsed or
refractory B cell non-Hodgkin lymphoma (r/r B-NHL) at EHA next
month. This year, we plan to submit an IND application for CB-011
to rapidly advance our second CAR-T program into the clinic, and we
expect to share target selection for CB-020, the first solid
tumor-targeted program from our CAR-NK platform.”
Recent Business Highlights
Pipeline
- CB-010: In April 2022, an abstract with initial clinical data
from the ANTLER Phase 1 trial of CB-010 in adults with relapsed or
refractory B cell non-Hodgkin lymphoma (r/r B-NHL) was accepted at
EHA, being held in Vienna, Austria, June 9-17, 2022.
- Caribou’s lead product candidate, 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 continues to enroll patients in ANTLER.
- CB-011: Caribou is conducting IND-enabling studies to support
an IND application submission in H2 2022 in patients with relapsed
or refractory multiple myeloma (r/r MM).
- In April 2022, promising preclinical data supporting the
development of CB-011 were presented at the American Association
for Cancer Research (AACR) Annual Meeting.
- 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. This immune cloaking strategy is designed to blunt both
T- and NK-mediated immune cell rejection, enabling more durable
antitumor activity.
Corporate
- 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.
- 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.
Anticipated Milestones for 2022 and Beyond
- CB-010: Caribou is scheduled to share initial data from its
ongoing ANTLER Phase 1 trial for CB-010, an anti-CD19 CAR-T cell
therapy for r/r B- NHL, at EHA in June 2022.
- CB-011: Caribou expects to submit an IND application for
CB-011, an anti-BCMA CAR-T cell therapy for r/r MM, in H2
2022.
- CB-020: Caribou expects to announce target selection for
CB-020, an iPSC-derived CAR-NK cell therapy for solid tumors, in Q4
2022. Additionally, Caribou expects to disclose multiple armoring
strategies under development for its CAR-NK platform in Q4
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
- May 16-19, 2022: 25th Annual Meeting of the American Society
for Gene and Cell Therapy (ASGCT). A poster with data highlighting
the mechanism underlying the superior specificity of its CRISPR
hybrid RNA-DNA (chRDNA) guides for genome editing of primary human
T cells will be presented on Monday, May 16, 2022, 5:30 - 6:30 pm
ET
- June 9-17: European Hematology Association (EHA) 2022 Hybrid
Congress. Initial ANTLER Phase 1 clinical data for CB-010 is
scheduled to be presented
- June 23-24: SingHealth Duke-NUS Cell Therapy Centre (SDCT) and
Regenerative Medicine Institute of Singapore (REMEDIS) Annual
Conference. An encore presentation of initial ANTLER data will be
presented
- July 18-22: Pan Pacific Lymphoma Conference 2022. An encore
presentation of initial ANTLER data will be presented
First Quarter 2022 Financial Results
Cash, cash equivalents, and marketable
securities: Caribou had $390.8 million in cash, cash
equivalents, and marketable securities as of March 31, 2022
compared to $413.5 million as of December 31, 2021.
Licensing and collaboration revenue: Revenue
from Caribou’s licensing and collaboration agreements was $2.7
million for the three months ended March 31, 2022 compared to $1.6
million for the same period in 2021. The increase was primarily due
to an increase in revenue recognized pursuant to the AbbVie
collaboration and license agreement.
R&D expenses: Research and development
expenses were $13.9 million for the three months ended March 31,
2022 compared to $10.2 million for the same period in 2021. The
increase was primarily due to personnel-related expenses
attributable to increased headcount, costs associated with clinical
trial and preclinical study activities, and facilities expenses,
partially offset by a decrease in expenses related to licensing,
sublicensing revenue, and milestones.
G&A expenses: General and
administrative expenses were $9.6 million for the three months
ended March 31, 2022 compared to $4.6 million for the same period
in 2021. The increase was primarily due to personnel-related
expenses attributable to increased headcount, legal and accounting
services, insurance, other expenses associated with operating as a
public company, and facilities and other expenses.
Other income (expense): The Company recorded
other income of $1.8 million for the three months ended March 31,
2022 compared to less than $0.1 million for the same period in
2021. This increase was primarily due to the non-cash change in
fair value of the success payments liability under the Memorial
Sloan Kettering Cancer Center (MSKCC) exclusive license
agreement.
Net loss: For the three months ended March 31,
2022, net loss was $19.1 million compared to $13.2 million for the
same period in 2021.
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 Class 2 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 are
capable of editing 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
CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced “chardonnays”)
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 Statements This 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 and expectations relating to the
release of patient data from its ongoing 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,
risks inherent in development of cell therapy products;
uncertainties related to the initiation, cost, timing, progress,
and results of current and future research and development
programs, preclinical studies, and clinical trials; and the risk
that initial or interim clinical trial data will not ultimately be
predictive of the safety and efficacy of Caribou’s product
candidates or that clinical outcomes may differ as more patient
data becomes available; 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, and subsequent filings. 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)
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
Cash, cash equivalents, and marketable securities |
|
$ |
390,823 |
|
$ |
413,508 |
|
Total assets |
|
|
445,997 |
|
|
442,356 |
|
Total liabilities |
|
|
74,200 |
|
|
54,531 |
|
Total stockholders' equity |
|
|
371,797 |
|
|
387,825 |
|
Total liabilities and stockholders' equity |
|
$ |
445,997 |
|
$ |
442,356 |
|
|
|
|
|
|
|
Caribou Biosciences, Inc.Condensed Consolidated
Statement of Operations(in thousands, except share and per share
data)(unaudited)
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Licensing and collaboration revenue |
|
$ |
2,664 |
|
|
$ |
1,586 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
13,924 |
|
|
|
10,165 |
|
General and administrative |
|
|
9,593 |
|
|
|
4,596 |
|
Total operating expenses |
|
|
23,517 |
|
|
|
14,761 |
|
Loss from operations |
|
|
(20,853 |
) |
|
|
(13,175 |
) |
Other income (expense): |
|
|
|
|
Change in fair value of equity securities |
|
|
(88 |
) |
|
|
— |
|
Change in fair value of the MSKCC success payments liability |
|
|
1,596 |
|
|
|
— |
|
Other income - net |
|
|
257 |
|
|
|
16 |
|
Total other income (expense) |
|
|
1,765 |
|
|
|
16 |
|
Net loss |
|
|
(19,088 |
) |
|
|
(13,159 |
) |
Other comprehensive loss: |
|
|
|
|
Net unrealized loss on available-for-sale marketable securities,
net of tax |
|
|
(954 |
) |
|
|
- |
|
Net comprehensive loss |
|
$ |
(20,042 |
) |
|
$ |
(13,159 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.32 |
) |
|
$ |
(1.39 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
60,546,170 |
|
|
|
9,499,448 |
|
|
|
|
|
|
Caribou Biosciences, Inc.
Contacts:Amy Figueroa, CFAInvestor Relations and
Corporate Communications afigueroa@cariboubio.com
Investors and Media:Elizabeth Wolffe, Ph.D.,
and Sylvia WheelerWheelhouse
LSAlwolffe@wheelhouselsa.comswheeler@wheelhouselsa.com
Caribou Biosciences (NASDAQ:CRBU)
Historical Stock Chart
From Jun 2024 to Jul 2024
Caribou Biosciences (NASDAQ:CRBU)
Historical Stock Chart
From Jul 2023 to Jul 2024