Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today reported
financial results for the third quarter of 2022 and provided a
business update.
“We have seen highly promising results from our lead allogeneic
cell therapy, CB-010, at the lowest starting dose in the ANTLER
clinical trial in patients with relapsed or refractory B cell
non-Hodgkin lymphoma,” said Rachel Haurwitz, Ph.D., Caribou’s
president and chief executive officer. “The safety and antitumor
activity for CB-010 at dose level 1 are encouraging, and we look
forward to generating additional efficacy and durability data from
the dose escalation phase of the ANTLER trial. In addition,
progress continues across our pipeline as we submitted our second
IND, for CB-011, in the fourth quarter and plan to submit our third
IND, for CB-012, in 2023. Later this year, we look forward to
sharing the target selection for CB-020, the lead program in our
CAR-NK platform for solid tumors.”
Recent Business Highlights
Pipeline and Technology
- For CB-011, an investigational new drug (IND) application was
submitted to the U.S. Food and Drug Administration (FDA) in Q4 2022
for relapsed or refractory multiple myeloma (r/r MM).
- CB-010 and the ANTLER Phase 1 trial:
- In October 2022, a poster for a case report on long-term follow
up for the first patient dosed in the ANTLER Phase 1 trial was
presented at the Lymphoma, Leukemia, & Myeloma (LL&M)
Congress. This patient achieved a complete response (CR) at day 28
and maintained a long-term CR at 15 months following a single dose
of CB-010 at dose level 1 (40x106 CAR-T cells). Before joining the
ANTLER trial, the patient had received eight prior lines of
systemic anti-cancer therapy for relapsed aggressive B cell
non-Hodgkin lymphoma (r/r B-NHL).
- Based on the promising initial safety data and response rates
at dose level 1, the ANTLER trial is currently enrolling patients
at dose level 2 (80x106 CAR-T cells).
- In September 2022, CB-010 was granted Orphan Drug Designation
(ODD) for follicular lymphoma (FL) by the FDA. Patients with
aggressively behaving FL are 1 of 7 subtypes of r/r B-NHL patients
eligible for enrollment in the dose escalation portion of the
ANTLER Phase 1 trial.
- As previously reported:
- 6 of 6 patients (100%) achieved a CR as their best
response
- 3 of 6 patients (50%) maintained a CR at 6 months
- 15 months has been the longest CR, achieved by the first
patient dosed with CB-010
- CB-010 at dose level 1 was generally well tolerated in the
ANTLER trial
Anticipated Milestones for Fourth Quarter 2022 and
Beyond
- CB-010: Caribou plans to share additional data from cohort 1 of
the ongoing ANTLER Phase 1 trial for CB-010, an allogeneic
anti-CD19 CAR-T cell therapy for r/r B-NHL, by YE 2022.
- CB-011: Caribou anticipates the FDA’s
response to Caribou’s IND application for CB-011, an allogeneic
anti-BCMA CAR-T cell therapy for r/r MM, by YE 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 armoring strategies
under development for its CAR-NK cell platform in Q4 2022.
- CB-012: Caribou expects to submit an
IND application for CB-012, an allogeneic anti-CLL-1 CAR-T cell
therapy for relapsed or refractory acute myeloid leukemia (r/r
AML), in 2023.
Upcoming Meetings
- American Society of Hematology (ASH) 64th Annual Meeting,
December 10-13, 2022
- Trial-in-progress poster presentation for the ANTLER Phase 1
trial of CB-010 in r/r B-NHL
- Caribou management plans to participate in the following
upcoming investor conferences:
- November 14: Barclays 2022 Gene Editing & Gene Therapy
Summit
- November 17: Jefferies Global Healthcare Conference
- November 30: 5th Annual Evercore ISI HealthCONx Conference
- December 7: BofA Securities Biotech SMID Cap Conference
Third Quarter 2022 Financial Results
Cash, cash equivalents, and marketable
securities: Caribou had $342.6 million in cash, cash
equivalents, and marketable securities as of September 30, 2022,
compared to $413.5 million as of December 31, 2021.
Licensing and collaboration revenue: Revenue
from Caribou’s licensing and collaboration agreements was $3.3
million for the three months ended September 30, 2022, compared to
$4.0 million for the same period in 2021. The decrease was
primarily due to a decrease in revenue under the AbbVie
collaboration and license agreement.
R&D expenses: Research and development
expenses were $20.0 million for the three months ended September
30, 2022, compared to $15.8 million for the same period in 2021.
The increase was primarily due to costs to advance pipeline
programs; increased headcount, including stock-based compensation;
and facilities and other expenses; partially offset by a decrease
related to the timing of external manufacturing activities.
G&A expenses: General and
administrative expenses were $9.8 million for the three months
ended September 30, 2022, compared to $6.8 million for the same
period in 2021. The increase was primarily due to costs for
increased headcount, including stock-based compensation; facilities
and other expenses; and legal, accounting, insurance, and other
expenses necessary to support the growth and operation of a
clinical-stage public company.
Net loss: Caribou reported a net loss of $26.6
million for the three months ended September 30, 2022, compared to
a net loss of $21.0 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 expectations regarding 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 related to our limited operating history,
history of net operating losses, financial position and our ability
to raise additional capital as needed to fund our operations and
product candidate development; 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; risks related to our ability to
obtain and maintain regulatory approval for our product candidates;
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)
|
September 30,2022 |
|
December 31,2021 |
Cash, cash equivalents, and marketable securities |
$ |
342,590 |
|
$ |
413,508 |
Total assets |
|
398,823 |
|
|
442,356 |
Total liabilities |
|
74,709 |
|
|
54,531 |
Total stockholders'
equity |
|
324,114 |
|
|
387,825 |
Total liabilities and
stockholders' equity |
$ |
398,823 |
|
$ |
442,356 |
|
|
|
|
|
|
Caribou Biosciences, Inc.Condensed Consolidated
Statement of Operations(in thousands, except share and per share
data)(unaudited)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Licensing and collaboration
revenue |
$ |
3,303 |
|
|
$ |
3,977 |
|
|
$ |
10,159 |
|
|
$ |
7,039 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
19,991 |
|
|
|
15,833 |
|
|
|
56,494 |
|
|
|
37,144 |
|
General and administrative |
|
9,849 |
|
|
|
6,760 |
|
|
|
29,486 |
|
|
|
16,469 |
|
Total operating expenses |
|
29,840 |
|
|
|
22,593 |
|
|
|
85,980 |
|
|
|
53,613 |
|
Loss from operations |
|
(26,537 |
) |
|
|
(18,616 |
) |
|
|
(75,821 |
) |
|
|
(46,574 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of equity securities |
|
31 |
|
|
|
— |
|
|
|
(73 |
) |
|
|
— |
|
Change in fair value of the MSKCC success payments liability |
|
(1,607 |
) |
|
|
(2,403 |
) |
|
|
1,041 |
|
|
|
(3,584 |
) |
Gain on extinguishment of PPP Loan |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,584 |
|
Other income, net |
|
1,466 |
|
|
|
45 |
|
|
|
2,421 |
|
|
|
130 |
|
Total other income (expense) |
|
(110 |
) |
|
|
(2,358 |
) |
|
|
3,389 |
|
|
|
(1,870 |
) |
Net loss |
$ |
(26,647 |
) |
|
$ |
(20,974 |
) |
|
$ |
(72,432 |
) |
|
$ |
(48,444 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
Net unrealized loss on available-for-sale marketable securities,
net of tax |
|
(454 |
) |
|
|
— |
|
|
|
(1,900 |
) |
|
|
— |
|
Net comprehensive loss |
$ |
(27,101 |
) |
|
$ |
(20,974 |
) |
|
$ |
(74,332 |
) |
|
$ |
(48,444 |
) |
Net loss per share, basic and
diluted |
$ |
(0.44 |
) |
|
$ |
(0.46 |
) |
|
$ |
(1.19 |
) |
|
$ |
(2.20 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
60,886,921 |
|
|
|
45,889,646 |
|
|
|
60,731,520 |
|
|
|
22,052,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Caribou Biosciences, Inc. Contacts:
Investors:Amy Figueroa,
CFAafigueroa@cariboubio.com
Media:Peggy Vorwald,
Ph.D.pvorwald@cariboubio.com
Investors and Media: Elizabeth Wolffe, Ph.D.,
and Sylvia WheelerWheelhouse LSA
lwolffe@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