Catalyst Biosciences Reports Second Quarter 2021 Operating & Financial Results and Provides a Corporate Update
August 05 2021 - 7:00AM
Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its
operating and financial results for the second quarter ended June
30, 2021, and provided a corporate update.
"We continue to make progress in our complement
and hemostasis programs. In complement, we are advancing the
development of our SQ enhanced CFI development candidate, CB 4332,
where we screened the first patient in our natural history study
for CFI deficiency (“ConFIrm”). We also recently disclosed new
proteases from our ProTUNE™; C3b-C4b degrader and ImmunoTUNE™;
C3a-C5a degrader platforms designed to target specific disorders of
the complement or inflammatory pathways,” said Nassim Usman, Ph.D.,
president and chief executive officer of Catalyst. “With the
initiation of the ConFIrm study and our plans to enter the clinic
with CB 4332 in 2022 on track, we are building a robust pipeline in
complement. We also continue to make progress in our Crimson 1
Phase 3 registrational study of MarzAA, in hemophilia A or B with
inhibitors as well as in our Phase 1/2 trial in other rare bleeding
disorders.”
Recent Milestones
Marzeptacog alfa (activated) – MarzAA
- The Food and Drug Administration (FDA) has granted Fast Track
Designation for MarzAA for treatment of episodic bleeding in
subjects with Factor FVII deficiency in June 2021. The FDA granted
the Fast Track Designation for the treatment of episodic bleeding
in subjects with Hemophilia A or B with inhibitors in December
2020.
- Presented four posters at the International Society for
Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress in July
2021. The data presented support the Company’s ongoing trials of
MarzAA in hemostasis.
Systemic Complement Program
- Launched the ConFIrm study with the screening of the first
patient in its CFI-deficiency study in the CB 4332 program,
Catalyst’s wholly-owned, first-in-class, enhanced Complement Factor
I (CFI), intended for prophylactic subcutaneous (SQ) administration
in individuals with CFI deficiency. The ConFIrm screening
study will measure CFI levels and activity in patients who have
diseases related to a CFI deficiency and who may potentially
benefit from CB 4332 treatment.
- Hosted a research and development
day on its protease medicines platform focusing on the regulation
of complement, including CB 4332. The event featured a presentation
by Filomeen Haerynck, M.D., Ph.D., University of
Ghent, Belgium, who discussed the clinical phenotype, current
treatment landscape and unmet medical need in treating patients
with complement factor I (CFI) deficiency and other complement
system disorders. Members of the Catalyst management team also
discussed the proteases from the Company’s degrader platforms,
designed to target specific disorders of the complement and other
inflammatory pathways as well as other complement programs in
development.
Corporate
- Catalyst announced that it has promoted Grant Blouse, Ph.D., to
chief scientific officer and Tom Knudsen, DVM, Ph.D., to
senior vice president, corporate development. Howard Levy,
M.B.B.Ch, Ph.D., M.M.M., chief medical officer, announced his plan
to retire and transition to a senior clinical advisor role to
Catalyst.
Expected Milestones
Systemic Complement Program
- Advance CB 2782-PEG, the C3 degrader for the potential
treatment of dry AMD in collaboration with Biogen towards the
clinic
- Provide additional preclinical data supporting continued
development of the C4b degrader program and other complement
assets
- Submit an IND and initiate global clinical trial of CB
4332
- Announce development candidates in lead discovery programs
- Present PK and biomarker data for CB 4332
MarzAA
- Continue enrolling the Crimson 1 Phase 3 registrational and the
Phase 1/2 trials
- Submit the first Crimson 1 report to the Data and Safety
Monitoring Board (DSMB)
- Present PK data from the Phase 1/2 trial
Second Quarter 2021 Results and
Financial Highlights
- Cash, cash equivalents and
short-term investments, as of June 30, 2021 were $86.5
million.
- Research and development expenses
were $15.4 million and $12.9 million during the three months ended
June 30, 2021 and 2020, respectively, an increase of $2.5 million,
or 19%. The increase was due primarily to an increase of $1.4
million in personnel and facilities costs and an increase of $1.5
million in clinical and manufacturing costs, partially offset by a
decrease of $0.4 million in preclinical spending.
- General and administrative expenses
were $4.5 million and $4.4 million during the three months ended
June 30, 2021 and 2020, respectively, an increase of $0.1 million,
or 3%. This increase was due primarily to an increase of $0.3 in
personnel-related costs, partially offset by $0.2 million in
facilities and overhead costs.
- Interest and other income
(expense), net was $0.0 million and $0.1 million during the three
months ended June 30, 2021 and 2020, respectively, a decrease of
$0.1 million. The decrease was primarily due to a decrease in
interest income on investments.
- Net loss attributable to common
stockholders for the three-months ended June 30,
2021 was $19.9 million, or ($0.64) per basic and diluted
share, compared with $17.2 million, or ($0.96) per basic and
diluted share, for the prior year period.
- As of June 30, 2021, the
Company had 31,349,740 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
preclinical C3-degrader program licensed to Biogen for dry
age-related macular degeneration, an improved complement factor I
protease for SQ replacement therapy in patients with CFI deficiency
and proteases from our ProTUNE™ C3b-C4b degrader and ImmunoTUNE™
C3a-C5a degrader platforms designed to target specific disorders of
the complement or inflammatory pathways as well as other complement
programs in development.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. Forward-looking
statements include, without limitation, statements about the
product candidates of Catalyst Biosciences, Inc. (the “Company”)
and the benefits of its protease engineering platform; plans to
complete the ConFIrm and ConFIdence studies and the expectation
that the studies will inform opportunities to develop CB 4332;
plans to submit an IND for CB 4332; plans to announce development
candidates in lead discovery programs and present PK and biomarker
data for CB 4332; plans to continue enrollment of the Phase 3 and
Phase 1/2 trials of MarzAA; the potential markets for and
advantages of the Company's complement product candidates,
including CB 2782-PEG, CB 4332 and complement degraders; plans for
the Company's collaboration with Biogen; and plans to start a
clinical trial of CB 4332 in 2022.
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, the risk that the
ConFIrm and ConFIdence trials will not validate the potential
market for CB 4332; the risk Catalyst may elect to terminate or
postpone ongoing development programs, including development of
MarzAA or any of the Company’s complement assets; the risk that the
Company will need to raise additional capital, which may not be
available on faorable terms if at all; the risk that Biogen will
terminate Catalyst's agreement, and other risks described in the
"Risk Factors" section of the Company's Quarterly Report on Form
10-Q filed with the Securities and Exchange
Commission on May 6, 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 KaporCatalyst Biosciences, Inc.investors@catbio.com
Catalyst Biosciences,
Inc.Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
73,621 |
|
|
$ |
30,360 |
|
Short-term investments |
|
|
12,902 |
|
|
|
48,994 |
|
Accounts receivable |
|
|
1,971 |
|
|
|
3,313 |
|
Prepaid and other current assets |
|
|
8,332 |
|
|
|
6,843 |
|
Total current assets |
|
|
96,826 |
|
|
|
89,510 |
|
Long-term investments |
|
|
— |
|
|
|
2,543 |
|
Other assets, noncurrent |
|
|
1,169 |
|
|
|
528 |
|
Right-of-use assets |
|
|
3,107 |
|
|
|
1,832 |
|
Property and equipment, net |
|
|
684 |
|
|
|
433 |
|
Total
assets |
|
$ |
101,786 |
|
|
$ |
94,846 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,834 |
|
|
$ |
5,931 |
|
Accrued compensation |
|
|
2,516 |
|
|
|
2,476 |
|
Deferred revenue |
|
|
2,038 |
|
|
|
1,983 |
|
Other accrued liabilities |
|
|
7,366 |
|
|
|
6,743 |
|
Operating lease liability |
|
|
1,814 |
|
|
|
663 |
|
Total current liabilities |
|
|
15,568 |
|
|
|
17,796 |
|
Operating lease liability,
noncurrent |
|
|
1,054 |
|
|
|
981 |
|
Total liabilities |
|
|
16,622 |
|
|
|
18,777 |
|
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;
31,349,740 and 22,097,820 shares issued and outstanding at June 30,
2021 and December 31, 2020, respectively |
|
|
31 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
442,258 |
|
|
|
390,803 |
|
Accumulated other comprehensive income |
|
|
2 |
|
|
|
5 |
|
Accumulated deficit |
|
|
(357,127 |
) |
|
|
(314,761 |
) |
Total stockholders’ equity |
|
|
85,164 |
|
|
|
76,069 |
|
Total liabilities and
stockholders’ equity |
|
$ |
101,786 |
|
|
$ |
94,846 |
|
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts) (Unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
License |
|
$ |
— |
|
|
$ |
23 |
|
|
$ |
— |
|
|
$ |
15,068 |
|
Collaboration |
|
|
1,132 |
|
|
|
1,635 |
|
|
|
2,599 |
|
|
|
2,956 |
|
License and collaboration
revenue |
|
|
1,132 |
|
|
|
1,658 |
|
|
|
2,599 |
|
|
|
18,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of license |
|
|
— |
|
|
|
23 |
|
|
|
— |
|
|
|
3,070 |
|
Cost of collaboration |
|
|
1,139 |
|
|
|
1,719 |
|
|
|
2,619 |
|
|
|
3,151 |
|
Research and development |
|
|
15,389 |
|
|
|
12,906 |
|
|
|
32,402 |
|
|
|
26,170 |
|
General and administrative |
|
|
4,518 |
|
|
|
4,371 |
|
|
|
9,930 |
|
|
|
8,062 |
|
Total operating expenses |
|
|
21,046 |
|
|
|
19,019 |
|
|
|
44,951 |
|
|
|
40,453 |
|
Loss from operations |
|
|
(19,914 |
) |
|
|
(17,361 |
) |
|
|
(42,352 |
) |
|
|
(22,429 |
) |
Interest and other income
(expense), net |
|
|
(14 |
) |
|
|
113 |
|
|
|
(14 |
) |
|
|
1,128 |
|
Net loss |
|
$ |
(19,928 |
) |
|
$ |
(17,248 |
) |
|
$ |
(42,366 |
) |
|
$ |
(21,301 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(0.96 |
) |
|
$ |
(1.42 |
) |
|
$ |
(1.31 |
) |
Shares used to compute net loss
per share attributable to common stockholders, basic and
diluted |
|
|
31,348,602 |
|
|
|
17,891,475 |
|
|
|
29,875,202 |
|
|
|
16,241,963 |
|
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