Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today reported
business highlights and financial results for the second quarter of
2021.
“2021 has been a transformational year for
Caribou, and we believe that our highly successful IPO speaks to
the enormous potential of the company’s chRDNA technology to
deliver innovative, transformative therapies for patients
with devastating diseases,” said Rachel Haurwitz, Ph.D.,
Caribou’s president and chief executive officer. "In July, we
announced the dosing of the first patient in our ANTLER Phase 1
clinical trial evaluating our lead product candidate, CB-010, in
relapsed or refractory B cell non-Hodgkin lymphoma. In addition to
this program, we have three other wholly-owned allogeneic cell
therapy product candidates in our pipeline, and we are
collaborating with AbbVie to research and develop two additional
allogeneic CAR-T programs for AbbVie using our Cas12a chRDNA
technology.”
Business Highlights
Dosed the first patient in Phase 1
clinical trial of CB-010. In July 2021, Caribou reported
dosing the first patient in its ANTLER Phase 1 clinical trial of
CB-010. The ANTLER trial is evaluating CB-010 in patients with
relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), and
initial data from the trial are expected in 2022.
Completed upsized IPO raising $349.6
million in gross proceeds. In July 2021, Caribou
completed its IPO, selling 19,000,000 shares of its common stock at
a price to the public of $16.00 per share, for gross proceeds of
$304.0 million. In August 2021, the underwriters fully exercised
their option to purchase an additional 2,850,000 shares of common
stock at the IPO price, increasing the total number of shares sold
by Caribou in the IPO to 21,850,000 shares and the aggregate gross
proceeds to $349.6 million. Aggregate net proceeds from the IPO,
after deducting underwriting discounts and commissions and other
offering expenses payable by Caribou, were $321.0
million.
Expanded Caribou’s board of
directors. In August 2021, Nancy Whiting, Pharm.D., was
appointed to Caribou’s board of directors. Dr. Whiting, who most
recently served as executive vice president, corporate strategy,
alliances and communication of Seagen, Inc., brings over 17 years
of biotechnology industry expertise in drug and portfolio
development as well as significant strategic leadership experience.
Dr. Whiting joins Scott Braunstein, M.D., Andrew Guggenhime, Rachel
Haurwitz, Ph.D., and Natalie Sacks, M.D., on Caribou’s board of
directors. In July 2021, Mr. Guggenhime assumed the roles of chair
of the board of directors and chair of the audit committee.
Published data demonstrating the
significantly improved specificity of Caribou’s proprietary CRISPR
hybrid RNA-DNA (chRDNA) guide technology compared to all-RNA
guides. In September 2021, Caribou and its collaborators
published studies in an article entitled, “Conformational control
of Cas9 by CRISPR hybrid RNA-DNA guides mitigates off-target
activity in T cells,” in the journal Molecular Cell.
Upcoming Milestones
CB-010: Caribou expects initial data
from the ongoing ANTLER Phase 1 trial in patients with relapsed or
refractory B-NHL in 2022. CB-010 is an allogeneic
anti-CD19 CAR-T cell therapy derived from healthy donor T cells
engineered using Cas9 chRDNA technology to introduce a
CD19-specific CAR into the TRAC gene locus, thus eliminating
expression of the T cell receptor to reduce the risk of graft
versus host disease. The T cells are further modified to knock out
the PDCD1 gene, preventing the expression of the PD-1 protein, to
boost the persistence of CAR-T cell antitumor activity.
CB-011: Caribou expects to file an
Investigational New Drug (IND) application for its CB-011 program
in 2022. CB-011 is an allogeneic anti-BCMA CAR-T cell
therapy derived from healthy donor T cells that is being developed
as a potential treatment for relapsed or refractory multiple
myeloma. Caribou is engineering healthy donor T cells using its
proprietary Cas12a chRDNA technology to introduce a BCMA-specific
CAR into the TRAC gene locus. In addition, Caribou utilizes an
immune cloaking strategy designed to prevent rapid immune rejection
of CB-011. This strategy comprises two edits: knockout of the
endogenous B2M gene and site-specific insertion of a B2M–HLA-E
fusion gene into the T cell genome.
CB-012: Caribou expects to file an IND
application for its CB-012 program in 2023. CB-012 is an
allogeneic anti-CD371 CAR-T cell therapy derived from healthy donor
T cells for the potential treatment of relapsed or refractory acute
myeloid leukemia. CB-012 cells are engineered using Caribou’s
proprietary Cas12a chRDNA technology to introduce a fully-human
CD371-specific CAR into the TRAC locus and to armor the cells to
promote persistence.
CB-020: Caribou expects to announce
target selection for its CB-020 program in 2022. CB-020, a
CAR-NK product candidate, is the lead program in Caribou’s
proprietary genome-edited iPSC-derived natural killer (iNK) cell
therapy platform. Multiplex-edited CAR-NKs hold significant
potential for treating a variety of solid tumor types.
Second Quarter 2021 Financial
Results
Cash and cash
equivalents: Caribou finished the second quarter of
2021 with cash and cash equivalents of $129.5 million. Cash and
cash equivalents as of June 30, 2021, do not include $321.0 million
in aggregate net proceeds from the company’s IPO completed in July
and August of 2021.
Licensing and collaboration
revenue: Revenue generated from Caribou’s licensing and
collaboration agreements was $1.5 million for the second quarter of
2021, compared to $8.5 million for the second quarter of 2020. The
decrease was primarily due to revenues recognized pursuant to an
exclusive license agreement the company entered into during the
second quarter of 2020.
R&D expenses: Research
and development expenses increased by $4.7 million to $12.3 million
in the second quarter of 2021, up from $7.6 million in the second
quarter of 2020. The increase in research and development expenses
was primarily due to an increase in costs associated with
intellectual property license and assignment agreements, costs
associated with pre-clinical programs, an increase in payroll and
related expenses, an increase in the fair value of the Memorial
Sloan Kettering Cancer Center (MSKCC) success payments liability,
and an increase in facilities and other allocated expenses.
G&A expenses: General
and administrative expenses increased by $2.0 million to $5.1
million in the second quarter of 2021, up from $3.2 million in the
second quarter of 2020. The increase in general and administrative
expenses was primarily due to an increase in recruiting and
personnel costs, legal and accounting services, and facilities and
maintenance expenses.
Net loss: Caribou reported
a net loss of $14.3 million in the second quarter of 2021, compared
with a net loss of $1.9 million for the second quarter of 2020.
About Caribou Biosciences,
Inc.
Caribou is a clinical-stage CRISPR
genome-editing biopharmaceutical company dedicated to transforming
the lives of patients with devastating diseases by applying the
company’s proprietary chRDNA technology toward the development of
next-generation, genome-edited allogeneic immune cell therapies.
The company is developing a pipeline of genome-edited,
off-the-shelf CAR-T and CAR-NK cell therapies for the treatment of
both hematologic malignancies and solid tumors. The therapies
target cell surface antigens for which autologous CAR-T cell
therapeutics have previously demonstrated clinical proof-of-concept
as well as additional emerging targets.
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
expectations. 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 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
final prospectus filed on July 23, 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. Media
Contact: |
Caribou Biosciences, Inc. Investor
Relations Contacts: |
Greg Kelley |
Elizabeth Wolffe, Ph.D., and
Sylvia Wheeler |
Ogilvy |
Wheelhouse LSA |
gregory.kelley@ogilvy.com |
lwolffe@wheelhouselsa.com |
617-461-4023 |
swheeler@wheelhouselsa.com |
– more –
|
Condensed
Consolidated Balance Sheet Data |
(in
thousands) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
129,524 |
|
|
$ |
15,953 |
|
Total assets |
|
|
158,397 |
|
|
|
36,046 |
|
Total liabilities |
|
|
55,938 |
|
|
|
18,160 |
|
Convertible preferred stock |
|
|
150,150 |
|
|
|
41,323 |
|
Total stockholders' (deficit) |
|
|
(47,691 |
) |
|
|
(23,437 |
) |
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statement of Operations |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
Licensing and collaboration revenue |
$ |
1,476 |
|
|
$ |
8,478 |
|
|
$ |
3,062 |
|
|
$ |
10,178 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
12,327 |
|
|
|
7,580 |
|
|
|
22,491 |
|
|
|
16,221 |
|
General and administrative |
|
5,113 |
|
|
|
3,153 |
|
|
|
9,709 |
|
|
|
6,641 |
|
Total operating expenses |
|
17,440 |
|
|
|
10,733 |
|
|
|
32,200 |
|
|
|
22,862 |
|
Loss from
operations |
|
(15,964 |
) |
|
|
(2,255 |
) |
|
|
(29,138 |
) |
|
|
(12,684 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
Interest income |
|
46 |
|
|
|
11 |
|
|
|
50 |
|
|
|
153 |
|
Interest expense |
|
(2 |
) |
|
|
(5 |
) |
|
|
(8 |
) |
|
|
(8 |
) |
Change in fair value of equity securities |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(733 |
) |
Gain on extinguishment of PPP loan |
|
1,584 |
|
|
|
- |
|
|
|
1,584 |
|
|
|
- |
|
Other income |
|
25 |
|
|
|
327 |
|
|
|
42 |
|
|
|
348 |
|
Total other income (expense) |
|
1,653 |
|
|
|
333 |
|
|
|
1,668 |
|
|
|
(240 |
) |
Net loss
before provision for income taxes |
|
(14,311 |
) |
|
|
(1,922 |
) |
|
|
(27,470 |
) |
|
|
(12,924 |
) |
Benefit from income taxes |
|
- |
|
|
|
(50 |
) |
|
|
- |
|
|
|
(1,252 |
) |
Net loss and
comprehensive loss |
$ |
(14,311 |
) |
|
$ |
(1,872 |
) |
|
$ |
(27,470 |
) |
|
$ |
(11,672 |
) |
Net loss per
share, basic and diluted |
$ |
(1.39 |
) |
|
$ |
(0.22 |
) |
|
$ |
(2.78 |
) |
|
$ |
(1.38 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
10,261,770 |
|
|
|
8,441,934 |
|
|
|
9,882,715 |
|
|
|
8,435,672 |
|
|
|
|
|
|
|
|
|
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