Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today reported
financial results for the second quarter of 2022 and provided a
business update.
“During the first half of this year, we made
significant progress advancing our pipeline of genome-edited
allogeneic CAR-T and CAR-NK cell therapies,” said Rachel Haurwitz,
Ph.D., Caribou’s president and chief executive officer. “We
recently presented encouraging initial clinical data at EHA from
our Phase 1 ANTLER trial for CB-010, demonstrating a 100% complete
response rate as the best response at dose level 1 in six patients
with relapsed or refractory B cell non-Hodgkin lymphoma. Based on
the promising initial safety and efficacy data at dose level 1, we
are enrolling patients at dose level 2. The ANTLER data have
exceeded our expectations and are an important step toward
validating our chRDNA genome-editing platform. We are excited to
advance our plans for future development of CB-010 and our broader
pipeline, including CB-011 for relapsed or refractory multiple
myeloma and CB-020, the first solid tumor-targeted program from our
CAR-NK platform.”
Recent Business Highlights
Pipeline and Technology
- ANTLER trial:
- Encouraging clinical data from the
ANTLER Phase 1 trial of CB-010 in patients with relapsed or
refractory B cell non-Hodgkin lymphoma (r/r B-NHL) were presented
in a poster at the European Hematology Association (EHA) 2022
Hybrid Congress. A 100% complete response (CR) rate (n=6) was
observed as best response following a single dose of CB-010 at dose
level 1 (40x106 CAR-T cells). CB-010 was generally well
tolerated.
- Following the EHA poster
presentation, 1 additional patient had their 6-month evaluation,
which showed they maintained a CR at 6 months, resulting in an
overall 50% 6-month CR rate (n=6) for cohort 1 following a single,
starting dose of CB-010.
- Additionally, as disclosed
concurrently with the EHA poster, the first patient treated with
CB-010 maintained a CR at 12 months.
- Based on the promising initial
safety data and response rate at dose level 1, the ANTLER trial is
currently enrolling patients at dose level 2 (80x106 CAR-T cells)
and the company plans to share additional cohort 1 ANTLER data by
YE 2022.
- chRDNA technology:
- Presentation of
data on Caribou’s CRISPR hybrid RNA-DNA (chRDNA) technology at the
25th Annual Meeting of the American Society for Gene and Cell
Therapy (ASGCT). The preclinical studies highlighted the mechanism
underlying the superior specificity of Caribou’s chRDNA guides for
genome editing of primary human T cells.
Corporate
- In May 2022, Caribou appointed
David Johnson to the board of directors. Mr. Johnson, who currently
serves as chief commercial officer at Global Blood Therapeutics, is
a seasoned executive with 30 years of commercial and operational
experience in the biopharmaceutical industry and has an impressive
record of successfully building commercial infrastructure and
launching new medicines for patients. Previously, Mr. Johnson
worked at Gilead Sciences, Inc. for 15 years and at GlaxoSmithKline
for 11 years.
- Caribou recently
hired several professionals with significant biotechnology and
pharmaceutical industry experience:
- Tonia Nesheiwat, Pharm.D., vice president of medical
affairs
- Daniel Poon, vice president of operations and information
technology
- Socorro Portella, M.D., vice president of clinical
development
- Saeid Yazdani, vice president of portfolio management
- In July 2022,
Caribou joined the American Society for Transplantation and
Cellular Therapy (ASTCT) Corporate Council to engage in joint
problem-solving and collaborative opportunities that will advance
the cause and culture of blood and marrow transplantation and
cellular therapy.
Anticipated Milestones for 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 anti-CD19 CAR-T cell therapy for r/r B-NHL, by YE
2022.
- CB-011: Caribou
expects to submit an IND application for CB-011, an anti-BCMA CAR-T
cell therapy for relapsed or refractory multiple myeloma (r/r MM),
in Q4 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 anti-CLL-1
CAR-T cell therapy for r/r acute myeloid leukemia (AML), in
2023.
Upcoming 2022 Meetings
- September 19-22: 7th Annual CAR-TCR
Summit
- Syed Rizvi, M.D., Caribou’s chief medical officer, to present
an encore of initial ANTLER clinical data
- Justin Skoble, Ph.D., Caribou’s vice president of technical
operations, to present on how Caribou’s chRDNA genome-editing
technology is being applied to increase persistence and antitumor
activity in preclinical models
- In September and October, Caribou
management plans to participate in the following investor
conferences:
- September 7-8: Citi 17th Annual
BioPharma Conference 2022
- September 12-14: Morgan Stanley
20th Annual Global Healthcare Conference
- September 13: H.C. Wainwright 24th
Annual Global Investment Conference
- September 29-30: Jefferies Cell and
Genetic Medicine Summit
- October 6: BMO BioPharma Spotlight
Series - Gene Editing & Therapy
Second Quarter 2022 Financial Results
Cash, cash equivalents,
and marketable securities: Caribou had $366.1 million
in cash, cash equivalents, and marketable securities as of June 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 $4.2 million for the three months
ended June 30, 2022, compared to $1.5 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 $22.6 million for the three months
ended June 30, 2022, compared to $12.3 million for the same period
in 2021. The increase was primarily due to external activities
related to the ANTLER Phase 1 clinical trial and contract
manufacturing for CB-010 and additional product candidates; other
research and development expenses to advance IND-enabling studies
for CB-011 and preclinical research for additional programs;
personnel-related expenses, including stock-based compensation,
attributable to increased headcount; and facility expenses;
partially offset by a decrease in expenses relating to licensing,
sublicensing revenue, and milestones.
G&A expenses: General
and administrative expenses were $10.0 million for the three months
ended June 30, 2022, compared to $5.1 million for the same period
in 2021. The increase was primarily due to personnel-related
expenses, including stock-based compensation, attributable to
increased headcount; facilities and other expenses; and legal,
accounting, insurance, and other expenses associated with operating
as a public company; partially offset by a decrease in patent cost
reimbursements.
Net loss: Caribou reported a
net loss of $26.7 million for the three months ended June 30, 2022,
compared to $14.3 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 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 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)
|
|
June 30, 2022 |
|
December 31, 2021 |
Cash, cash equivalents, and marketable securities |
|
$ |
366,076 |
|
$ |
413,508 |
Total assets |
|
421,367 |
|
442,356 |
Total liabilities |
|
73,478 |
|
54,531 |
Totalstockholders' equity |
|
347,889 |
|
387,825 |
Total liabilities and
stockholders' equity |
|
$ |
421,367 |
|
$ |
442,356 |
|
|
|
|
|
Caribou Biosciences, Inc.Condensed Consolidated
Statement of Operations(in thousands, except share and per share
data)(unaudited)
|
|
Three Months Ended, June 30, |
|
Six Months Ended, June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Licensing and collaboration revenue |
|
$ |
4,192 |
|
|
$ |
1,476 |
|
|
$ |
6,856 |
|
|
$ |
3,062 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
22,579 |
|
|
12,327 |
|
|
36,503 |
|
|
22,491 |
|
General and administrative |
|
10,044 |
|
|
5,113 |
|
|
19,637 |
|
|
9,709 |
|
Total operating expenses |
|
32,623 |
|
|
17,440 |
|
|
56,140 |
|
|
32,200 |
|
Loss from operations |
|
(28,431 |
) |
|
(15,964 |
) |
|
(49,284 |
) |
|
(29,138 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of equity securities |
|
(16 |
) |
|
— |
|
|
(104 |
) |
|
— |
|
Change in fair value of the MSKCC success payments
liability |
|
1,052 |
|
|
— |
|
|
2,648 |
|
|
— |
|
Gain on extinguishment of PPP Loan |
|
— |
|
|
1,584 |
|
|
— |
|
|
1,584 |
|
Other income, net |
|
698 |
|
|
69 |
|
|
955 |
|
|
84 |
|
Total other income (expense) |
|
1,734 |
|
|
1,653 |
|
|
3,499 |
|
|
1,668 |
|
Net loss |
|
$ |
(26,697 |
) |
|
$ |
(14,311 |
) |
|
$ |
(45,785 |
) |
|
$ |
(27,470 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized loss on available-for-sale marketable securities,
net of tax |
|
(492 |
) |
|
— |
|
|
(1,446 |
) |
|
— |
|
Net comprehensive loss |
|
$ |
(27,189 |
) |
|
$ |
(14,311 |
) |
|
$ |
(47,231 |
) |
|
$ |
(27,470 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.44 |
) |
|
$ |
(1.39 |
) |
|
$ |
(0.75 |
) |
|
$ |
(2.78 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
60,757,689 |
|
|
10,261,770 |
|
|
60,652,532 |
|
|
9,882,715 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.com swheeler@wheelhouselsa.com
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