Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage
CRISPR genome-editing biopharmaceutical company, today reported
business highlights and financial results for the third quarter of
2021.
“Our important progress during 2021 continues as
we advanced our lead therapeutic product candidate into the clinic,
completed a successful IPO, and expanded our leadership team with
highly experienced and regarded professionals,” said Rachel
Haurwitz, Ph.D., Caribou’s president and chief executive officer.
“Caribou’s differentiated chRDNA genome-editing technology and
proprietary delivery approach enable high specificity multiplex
editing, which we believe is key to the creation of sophisticated
allogeneic CAR-T and CAR-NK therapies that have the potential to
provide persistent antitumor activity. We are developing our four
wholly-owned allogeneic cell therapy product candidates for the
treatment of hematologic and solid tumors, including our lead
product candidate, CB-010, which is being evaluated in the ANTLER
Phase 1 clinical trial in patients with relapsed or refractory B
cell non-Hodgkin lymphoma. We look forward to achieving key
milestones in 2022, including our plans to disclose initial data
from the ANTLER trial as well as to file an IND for our next
product candidate, CB-011.”
Recent Business Highlights
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 demonstrating that its CRISPR hybrid RNA-DNA
(chRDNA) guide technology provides significantly improved
specificity compared to all-RNA guides, thereby enabling high
levels of intended genomic edits in cells while eliminating or
minimizing inadvertent off-target events. Higher specificity is a
key advantage of Caribou’s cell therapies and of critical
importance in therapies that contain multiple genome edits. The
data were described in a peer-reviewed article entitled,
“Conformational control of Cas9 by CRISPR hybrid RNA-DNA guides
mitigates off-target activity in T cells,” in the journal Molecular
Cell.
Expanded Caribou’s board of
directors. Ran Zheng and Dara Richardson-Heron, M.D., were
appointed to Caribou’s board of directors in September 2021 and
November 2021, respectively. Ms. Zheng brings over 25 years of
biotechnology industry leadership experience in biologics drug
development with broad expertise in technical operations and the
manufacture of gene and cell therapies and currently serves as
chief executive officer of Landmark Bio. Dr. Richardson-Heron has
over 25 years of leadership experience in the healthcare,
corporate, nonprofit, and government sectors. She previously served
as chief patient officer for Pfizer and chief executive officer for
the YWCA of the USA and for the Greater NYC Affiliate of Susan G.
Komen for the Cure. They join existing directors: Andrew Guggenhime
(board chair), Scott Braunstein, M.D., Rachel Haurwitz, Ph.D.,
Natalie Sacks, M.D., and Nancy Whiting, Pharm.D.
Added to Caribou’s leadership
team. In November 2021, Caribou appointed Ruhi Khan as
chief business officer. Ms. Khan brings over 20 years of business
development and investment management experience focused on the
biotechnology and pharmaceutical industries.
Completed upsized IPO raising $321.0
million in net proceeds. In July and August 2021, Caribou
completed its IPO, selling a total of 21,850,000 shares for
aggregate net proceeds of $321.0 million, after deducting
underwriting discounts and commissions and other offering
expenses.
Upcoming Milestones
CB-010: Caribou expects to disclose
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, and
with the intent of boosting 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 humanized
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 their 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.
Third Quarter 2021 Financial
Results
Cash and cash
equivalents: Caribou ended the third quarter of 2021
with cash and cash equivalents of $435.3 million, which includes
$321.0 million in aggregate net proceeds from the company’s IPO
completed in July and August 2021.
Licensing and collaboration
revenue: Revenue generated from Caribou’s licensing and
collaboration agreements was $4.0 million for the third quarter of
2021, compared to $1.2 million for the third quarter of 2020. The
increase was primarily due to revenue recognized pursuant to the
AbbVie collaboration agreement.
R&D expenses: Research
and development expenses were $15.8 million in the third quarter of
2021, compared to $6.2 million in the third quarter of 2020. The
increase was primarily due to costs associated with clinical trial
and pre-clinical study activities, payroll-related expenses for
increased headcount, and facilities expenses.
G&A expenses: General
and administrative expenses were $6.8 million in the third quarter
of 2021, compared to $3.2 million in the third quarter of 2020. The
increase was primarily due to payroll-related expenses for
increased headcount, legal and accounting services associated with
operating as a public company, and facilities and other
expenses.
Other income
(expense): The company recorded a non-cash expense of
$2.4 million related to the change in fair value of the success
payments liability under its license agreement with Memorial Sloan
Kettering Cancer Center (MSKCC) in the third quarter of 2021,
primarily related to the increase in the fair value of Caribou’s
common stock following the IPO.
Net loss: Net loss was
$21.0 million for the third quarter of 2021, compared to $7.9
million for the third 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.Condensed Consolidated
Balance Sheet Data(Unaudited)(In thousands)
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
Cash and cash equivalents |
$ |
435,310 |
|
$ |
15,953 |
|
|
Total
assets |
|
461,960 |
|
|
36,046 |
|
|
Total
liabilities |
|
57,559 |
|
|
18,160 |
|
|
Convertible
preferred stock |
|
— |
|
|
41,323 |
|
|
Total
stockholders' equity (deficit) |
|
404,401 |
|
|
(23,437 |
) |
|
Caribou Biosciences, Inc.Condensed Consolidated
Statement of Operations(Unaudited)(In thousands, except share and
per share data)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Licensing
and collaboration revenue |
|
$ |
3,977 |
|
|
$ |
1,198 |
|
|
$ |
7,039 |
|
|
$ |
11,377 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
15,833 |
|
|
|
6,180 |
|
|
|
37,144 |
|
|
|
22,401 |
|
General and administrative |
|
|
6,760 |
|
|
|
3,247 |
|
|
|
16,469 |
|
|
|
9,887 |
|
Total operating expenses |
|
|
22,593 |
|
|
|
9,427 |
|
|
|
53,613 |
|
|
|
32,288 |
|
Loss from
operations |
|
|
(18,616 |
) |
|
|
(8,229 |
) |
|
|
(46,574 |
) |
|
|
(20,911 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
22 |
|
|
|
4 |
|
|
|
72 |
|
|
|
157 |
|
Interest expense |
|
|
— |
|
|
|
(6 |
) |
|
|
(8 |
) |
|
|
(14 |
) |
Change in fair value of equity securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(733 |
) |
Change in fair value of the MSKCC success payments liability |
|
(2,403 |
) |
|
|
— |
|
|
|
(3,584 |
) |
|
|
— |
|
Gain on extinguishment of PPP loan |
|
|
— |
|
|
|
— |
|
|
|
1,584 |
|
|
|
— |
|
Other income |
|
|
23 |
|
|
|
85 |
|
|
|
66 |
|
|
|
431 |
|
Total other income (expense) |
|
|
(2,358 |
) |
|
|
83 |
|
|
|
(1,870 |
) |
|
|
(159 |
) |
Net loss
before provision for income taxes |
|
|
(20,974 |
) |
|
|
(8,146 |
) |
|
|
(48,444 |
) |
|
|
(21,070 |
) |
Benefit from income taxes |
|
|
— |
|
|
|
213 |
|
|
|
— |
|
|
|
1,465 |
|
Net loss and
comprehensive loss |
|
$ |
(20,974 |
) |
|
$ |
(7,933 |
) |
|
$ |
(48,444 |
) |
|
$ |
(19,605 |
) |
Net loss per
share, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.93 |
) |
|
$ |
(2.20 |
) |
|
$ |
(2.31 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
45,889,646 |
|
|
|
8,537,965 |
|
|
|
22,052,944 |
|
|
|
8,470,019 |
|
|
|
|
|
|
|
|
|
|
Caribou Biosciences,
Inc. Contact: |
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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