Catalyst Biosciences Reports First Quarter 2021 Operating & Financial Results and Provides a Corporate Update
May 06 2021 - 8:00AM
Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced its
operating and financial results for the first quarter ended March
31, 2021 and provided a corporate update.
“We made significant progress across our
Protease Medicines platform, specifically in our complement and
hemostasis programs. We are preparing to initiate an observational
trial in patients who have diseases related to CFI deficiency in
mid-year 2021 to support our SQ enhanced CFI development candidate
CB 4332 that will enter the clinic in 2022,” said Nassim Usman,
Ph.D., president and chief executive officer of Catalyst. “In
hemostasis, we dosed our first subject in the Crimson 1 Phase 3
registrational study of MarzAA, our next generation SQ FVIIa, in
hemophilia A or B with inhibitors and are enrolling patients in a
Phase 1/2 trial in other rare bleeding disorders.”
Recent Milestones
-
Marzeptacog alfa (activated) – MarzAA: Catalyst
announced the dosing of the first patient in the Company's Phase 3
registration trial (Crimson 1– MAA-304).
-
Complement Factor 3 Degrader Program: Catalyst
expanded its intellectual property estate and protection of its
complement assets with the issuance of U.S. Patent Number
10,954,501 B2 entitled: “Nucleic Acid Encoding Modified Membrane
Type Serine Protease 1 (MTSP-1) Polypeptides and Methods of Use.”
The patent covers nucleic acids encoding modified proteases that
selectively cleave and degrade complement factor 3 (C3) including
CB 2782-PEG licensed to Biogen for dry age-related macular
degeneration.
-
Factor IX (FIX) Gene Therapy Program: Catalyst
announced publication of preclinical FIX gene therapy data for CB
2679d-GT in Blood, the Journal of American Society of Hematology.
The paper, entitled: "Gene Therapy for Hemophilia B Using CB
2679d-GT: A Novel Factor IX Variant with Higher Potency than Factor
IX Padua," demonstrated superiority of the Company's CB 2679d-GT
gene therapy candidate over that of the R338L-Padua variant, which
is currently used in clinical trials.Expected
Milestones
- Systemic Complement
Program:
- Commence enrollment of an
observational trial in mid-2021 assessing the blood levels of CFI
in patients who have diseases related to CFI deficiency in order to
identify those who would benefit from CB 4332 treatment;
- Provide additional preclinical data
supporting continued development of the C4b degrader program and
other complement assets.
- MarzAA
- Announce first patient dosed in the
Phase 1/2 trial (MAA 202) for the treatment of episodic bleeding in
FVII Deficiency, Glanzmann Thrombasthenia, and Hemlibra
patients;
- Submit the first Crimson 1 report
to the Data and Safety Monitoring Board (DSMB).
First Quarter 2021 Results and Financial
Highlights
- Cash, cash equivalents and
short-term investments, as of March 31, 2021 were $107.0
million.
- Research and development expenses were $17.0 million and $13.3
million during the three months ended March 31, 2021 and 2020,
respectively, an increase of $3.7 million, or 28%. The increase was
due primarily to preclinical and personnel related costs.
- General and administrative expenses were $5.4 million and $3.7
million during the three months ended March 31, 2021 and 2020,
respectively, an increase of $1.7 million, or 47%. The increase was
due primarily to an increase of $0.8 million in personnel-related
costs, and an increase of $0.8 million in professional
services.
- Interest and other (expense), net was $0.0 million and $1.0
million during the three months ended March 31, 2021 and 2020,
respectively, a decrease of $1.0 million, or 100%. The decrease was
primarily due to a decreased interest rate and due to the payment
received in the first quarter of 2020 under an agreement associated
with neuronal nicotinic receptor asset sold in 2016.
- Net loss attributable to common
stockholders for the three-months ended March 31, 2021 was $22.4
million, or ($0.79) per basic and diluted share, compared with $4.1
million, or ($0.28) per basic and diluted share, for the prior year
period.
- As of March 31, 2021, the Company
had 28,385,432 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 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 continue
enrolling 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), commence enrollment of an observational trial in CB
4332 in mid-2021 and a clinical trial in 2022, and the scope of the
Company’s intellectual property protection for its complement
programs. 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 the Company’s
patents may be held invalid or may not provide the scope of
coverage anticipated, competition and other risks described in the
"Risk Factors" sections 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 KaporCatalyst Biosciences, Inc.investors@catbio.com
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets (In
thousands, except share and per share amounts)
|
|
March 31, 2021 |
|
|
December 31,2020 |
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
83,044 |
|
|
$ |
30,360 |
|
Short-term investments |
|
|
23,956 |
|
|
|
48,994 |
|
Accounts receivable |
|
|
1,006 |
|
|
|
3,313 |
|
Prepaid and other current assets |
|
|
8,514 |
|
|
|
6,843 |
|
Total current assets |
|
|
116,520 |
|
|
|
89,510 |
|
Long-term investments |
|
|
— |
|
|
|
2,543 |
|
Other
assets, noncurrent |
|
|
528 |
|
|
|
528 |
|
Right-of-use assets |
|
|
1,646 |
|
|
|
1,832 |
|
Property
and equipment, net |
|
|
382 |
|
|
|
433 |
|
Total assets |
|
$ |
119,076 |
|
|
$ |
94,846 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,956 |
|
|
$ |
5,931 |
|
Accrued compensation |
|
|
2,232 |
|
|
|
2,476 |
|
Deferred revenue |
|
|
1,332 |
|
|
|
1,983 |
|
Other accrued liabilities |
|
|
6,983 |
|
|
|
6,743 |
|
Operating lease liability |
|
|
678 |
|
|
|
663 |
|
Total current liabilities |
|
|
14,181 |
|
|
|
17,796 |
|
Operating lease liability, noncurrent |
|
|
806 |
|
|
|
981 |
|
Total
liabilities |
|
|
14,987 |
|
|
|
18,777 |
|
Commitments and Contingencies (Note 10) |
|
|
|
|
|
|
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;
31,331,027 and 22,097,820 shares issued and outstanding at March
31, 2021 and December 31, 2020, respectively |
|
|
31 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
441,252 |
|
|
|
390,803 |
|
Accumulated other comprehensive income |
|
|
5 |
|
|
|
5 |
|
Accumulated deficit |
|
|
(337,199 |
) |
|
|
(314,761 |
) |
Total stockholders’ equity |
|
|
104,089 |
|
|
|
76,069 |
|
Total liabilities and stockholders’ equity |
|
$ |
119,076 |
|
|
$ |
94,846 |
|
|
|
|
|
|
|
|
|
|
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts) (Unaudited)
|
|
Three Months Ended March 31, |
|
|
Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
License |
|
$ |
— |
|
|
$ |
15,045 |
|
Collaboration |
|
|
1,467 |
|
|
|
1,321 |
|
License
and collaboration revenue |
|
|
1,467 |
|
|
|
16,366 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of license |
|
|
— |
|
|
|
3,047 |
|
Cost of collaboration |
|
|
1,480 |
|
|
|
1,432 |
|
Research and development |
|
|
17,013 |
|
|
|
13,264 |
|
General and administrative |
|
|
5,412 |
|
|
|
3,691 |
|
Total operating expenses |
|
|
23,905 |
|
|
|
21,434 |
|
Loss
from operations |
|
|
(22,438 |
) |
|
|
(5,068 |
) |
Interest
and other income (expense), net |
|
|
— |
|
|
|
1,015 |
|
Net
loss |
|
$ |
(22,438 |
) |
|
$ |
(4,053 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.79 |
) |
|
$ |
(0.28 |
) |
Shares
used to compute net loss per share attributable to common
stockholders, basic and diluted |
|
|
28,385,432 |
|
|
|
14,592,451 |
|
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