Catalyst Biosciences Reports Fourth Quarter and Full-Year 2020 Operating & Financial Results and Provides a Corporate Update
March 04 2021 - 8:00AM
Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its
operating and financial results for the fourth quarter and
full-year ending December 31, 2020 and provided a corporate update.
"The past year was transformational for
Catalyst. We expanded our complement pipeline, introducing an
enhanced complement factor I (CFI) development candidate CB 4332,
announced a classical pathway regulator of C4b program, and
received Fast Track designation for MarzAA," said Nassim Usman,
Ph.D., president, and chief executive officer of Catalyst. "Our
year-end cash plus the net proceeds from our January financing
provide a total of over $130.0 million in capital to achieve
several value building milestones, including executing on our two
MarzAA clinical trials, initiating an observational trial for CB
4332, and continuing to deepen our pipeline with additional drug
candidates in our complement portfolio."
Recent Milestones
- Marzeptacog alfa (activated) – MarzAA:
The U.S. Food and Drug
Administration (FDA) granted Fast Track Designation for
Marzeptacog alfa (activated) – or MarzAA, the Company's
subcutaneously (SQ) administered next-generation engineered
coagulation Factor VIIa (FVIIa) for the treatment of episodic
bleeding in subjects with hemophilia A or B with inhibitors. The
Company also presented a poster at the Annual American Society of
Hematology (ASH) meeting in December 2020. Linda Neuman, MD, vice
president of clinical development, presented the rationale and
design of the Crimson 1 (MAA-304) Phase 3 study.
- Systemic Complement Regulator Program:
In December 2020, the Catalyst team hosted a research and
development meeting on the Company's first subcutaneously dosed
systemic complement development candidate, CB 4332, an extended
half-life CFI, and a C4b degrader program that targets classical
complement disorders. Catalyst is leveraging its proprietary
protease engineering platform expertise to develop several
proteases that regulate the complement cascade that can be applied
to treat many diseases.
- Completed a $52.8 million financing:
Catalyst raised approximately $52.8 million in gross
proceeds during the first quarter of 2021, before deducting
underwriting discounts and commissions and other estimated offering
expenses, in a total offering of 9,185,000 shares of its common
stock. Net proceeds from the offering were approximately $49.3
million. Cash, cash equivalents and investments, as of December 31,
2020 were $81.9 million.
Expected Near-Term
Milestones
- MarzAA:
- Initiate and enroll the Crimson 1 Phase 3 open-label trial
evaluating the efficacy of SQ MarzAA to treat episodic bleeding in
individuals with hemophilia A or B with inhibitors;
- Initiate and enroll a Phase 1/2 trial (MAA 202) in FVII
Deficiency, Glanzmann Thrombasthenia, and Hemlibra®
patients;
- Submit the first Crimson 1 report to the Data and Safety
Monitoring Board (DSMB).
- Systemic Complement Program:
- Commence enrollment of an observational trial in mid-2021
assessing CFI activity and genotype in patients who have diseases
associated with CFI deficiency to identify those who would benefit
from CB 4332 treatment.
Fourth Quarter and Full-Year 2020 Results and Financial
Highlights
- Cash, cash equivalents and investments, as of December 31, 2020
were $81.9 million. During the first quarter of 2021, the Company
completed equity financing raising approximately $49.3 million in
net proceeds.
- Research and development expense for the three-months and
year-ended December 31, 2020 was $14.6 million and $53.0 million,
respectively, compared with $10.8 million and $43.9 million for the
prior year periods, respectively. The increase was due primarily to
an increase in personnel-related costs, pre-clinical research and
facilities costs, partially offset by a decrease in clinical
manufacturing costs.
- General and administrative expense for the three-months and
year-ended December 31, 2020 was $4.3 million and $16.2 million,
respectively, compared with $3.2 million and $13.4 million for the
prior year periods, respectively. The increase was due primarily to
an increase in professional services and personnel-related
costs.
- Interest and other income, net, for the three-months and
year-ended December 31, 2020 was ($0.1) million and $1.1 million,
respectively, compared with $0.4 million and $2.1 million for the
prior year periods, respectively.
- In connection with its Biogen Agreement, the Company received a
$15.0 million upfront license fee on January 10, 2020 and made a
$3.0 million payment to Mosaic Biosciences that was recorded as the
cost of the license. The Company also recognized reimbursable
out-of-pocket third-party expenses of $2.0 million and $6.1 million
for the three-months and year-ended December 31, 2020,
respectively, which were recorded as costs of collaboration
revenue.
- Net loss attributable to common stockholders for the
three-months and year-ended December 31, 2020 was $18.9 million, or
($0.86) per basic and diluted share, and $56.2 million, or ($2.93)
per basic and diluted share, respectively, compared with $13.6
million, or ($1.23) per basic and diluted share,
and $55.2 million, or ($4.60) per basic and diluted
share, for the prior year periods, respectively.
- As of December 31, 2020, the Company had 22,097,820 shares of
common stock outstanding.
About Catalyst Biosciences, the Protease
Medicines companyCatalyst is a research and clinical
development biopharmaceutical company focused on addressing unmet
medical needs in rare disorders of the complement and coagulation
systems. Our protease engineering platform has generated two
late-stage clinical programs, including MarzAA, a subcutaneously
(SQ) administered next-generation engineered coagulation Factor
VIIa (FVIIa) for the treatment of episodic bleeding in subjects
with rare bleeding disorders. Our complement pipeline includes a
pre-clinical C3-degrader program partnered with Biogen for dry
age-related macular degeneration, an improved complement factor I
protease for SQ replacement therapy in patients with CFI deficiency
and C4b-degraders designed to target disorders of the classical
complement pathway as well as other complement programs in
development.
Forward-Looking Statements This
press release contains forward-looking statements that involve
substantial risks and uncertainties. Forward-looking statements
include statements about the potential benefits of products based
on Catalyst's engineered protease platform, plans to initiate and
enroll a Phase 3 open-label trial and a Phase 1/2 trial of MarzAA,
submit the first report to the Data and Safety Monitoring Board
(DSMB) in 2021, commence enrollment of an observational trial in CB
4332 in mid-2021, and to deepen the Company's pipeline. Actual
results or events could differ materially from the plans,
intentions, expectations and projections disclosed in the
forward-looking statements. Various important factors could cause
actual results or events to differ materially, including, but not
limited to, the risk that trials and studies may be delayed as a
result of COVID-19, competitive products and other factors, that
trials may not have satisfactory outcomes, that additional human
trials will not replicate the results from earlier trials, that
potential adverse effects may arise from the testing or use of
MarzAA, including the generation of neutralizing antibodies, the
risk that costs required to develop or manufacture the Company's
products will be higher than anticipated, including as a result of
delays in trial enrollment, development and manufacturing resulting
from COVID-19 and other factors, the risk that Biogen will
terminate Catalyst's agreement, competition and other risks
described in the "Risk Factors" section of the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 4, 2021, and in other filings with
the Securities and Exchange Commission. The Company does not
assume any obligation to update any forward-looking statements,
except as required by law.
Contact:
Ana Kapor Catalyst Biosciences, Inc.investors@catbio.com
Catalyst Biosciences,
Inc.Consolidated Balance Sheets(In
thousands, except shares and per share amounts)
|
December 31, 2020 |
|
|
December 31, 2019 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
30,360 |
|
|
$ |
15,369 |
|
Short-term investments |
|
48,994 |
|
|
|
61,496 |
|
Accounts receivable, net |
|
3,313 |
|
|
|
15,000 |
|
Prepaid and other current assets |
|
6,844 |
|
|
|
4,201 |
|
Total current assets |
|
89,511 |
|
|
|
96,066 |
|
Long-term investments |
|
2,543 |
|
|
|
— |
|
Other assets, noncurrent |
|
528 |
|
|
|
257 |
|
Right-of-use assets |
|
1,832 |
|
|
|
1,927 |
|
Property and equipment, net |
|
433 |
|
|
|
304 |
|
Total
assets |
$ |
94,847 |
|
|
$ |
98,554 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
5,931 |
|
|
$ |
4,279 |
|
Accrued compensation |
|
2,477 |
|
|
|
2,106 |
|
Deferred revenue |
|
1,983 |
|
|
|
15,000 |
|
Other accrued liabilities |
|
6,743 |
|
|
|
7,031 |
|
Operating lease liability |
|
663 |
|
|
|
483 |
|
Total current liabilities |
|
17.797 |
|
|
|
28,899 |
|
Operating lease liability,
noncurrent |
|
981 |
|
|
|
1,319 |
|
Total liabilities |
|
18,778 |
|
|
|
30,218 |
|
Commitments and Contingencies
(Note 7) |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 5,000,000 shares authorized;
zero shares issued and outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value, 100,000,000 shares authorized;
22,097,820 and 12,040,835 shares issued and outstanding
at December 31, 2020 and 2019, respectively |
|
22 |
|
|
|
12 |
|
Additional paid-in capital |
|
390,803 |
|
|
|
326,810 |
|
Accumulated other comprehensive income |
|
5 |
|
|
|
34 |
|
Accumulated deficit |
|
(314,761 |
) |
|
|
(258,520 |
) |
Total stockholders' equity |
|
76,069 |
|
|
|
68,336 |
|
Total liabilities and
stockholders' equity |
$ |
94,847 |
|
|
$ |
98,554 |
|
Catalyst Biosciences,
Inc.Consolidated Statements of
Operations(In thousands, except share and per share
amounts)
|
Year Ended December 31, |
|
|
2020 |
|
|
2019 |
|
License |
$ |
15,100 |
|
|
$ |
— |
|
Collaboration |
|
5,848 |
|
|
|
— |
|
License and collaboration
revenue |
|
20,948 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of license |
|
3,102 |
|
|
|
— |
|
Cost of collaboration |
|
6,061 |
|
|
|
— |
|
Research and development |
|
52,975 |
|
|
|
43,859 |
|
General and administrative |
|
16,180 |
|
|
|
13,418 |
|
Total operating expenses |
|
78,318 |
|
|
|
57,277 |
|
Loss from operations |
|
(57,370 |
) |
|
|
(57,277 |
) |
Interest and other income,
net |
|
1,129 |
|
|
|
2,099 |
|
Net loss |
$ |
(56,241 |
) |
|
$ |
(55,178 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(2.93 |
) |
|
$ |
(4.60 |
) |
Shares used to compute net loss
per share attributable to common stockholders, basic and
diluted |
|
19,179,299 |
|
|
|
12,004,489 |
|
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