Catalyst Biosciences Reports Fourth Quarter and Full-Year 2018 Operating & Financial Results and Provides a Corporate Update
March 07 2019 - 8:00AM
Completed enrollment of the MarzAA SQ Phase 2 trial
and demonstrated safety and clinical efficacy, with >90%
reduction in bleeding
Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced its
operating and financial results for the fourth quarter and
full-year ending December 31, 2018 and provided a corporate update.
“2019 will be a very exciting year for Catalyst
with several clinical and regulatory read outs expected throughout
the year,” said Nassim Usman, Ph.D., president and chief executive
officer of Catalyst. “Both Phase 2 trials demonstrate that our
therapies are clinically efficacious when dosed subcutaneously,
which we believe is the future for hemophilia treatments.
Subcutaneous MarzAA and DalcA have the potential to be disruptive
to current intravenous products, an approximately $3.4 billion
market, and they are especially well-suited for children.”
Recent Milestones:
- Marzeptacog alfa (activated) – MarzAA,
subcutaneously administered next-generation engineered coagulation
Factor VIIa: Completed enrollment of 11 individuals, with
hemophilia and an inhibitor in a Phase 2 efficacy trial. The trial
is evaluating the ability of MarzAA to eliminate, or minimize,
spontaneous bleeding episodes in individuals with hemophilia A or B
with an inhibitor. As of February 2019, seven of 11 subjects had
completed dosing with a reduction in annual bleed rates (ABR) from
18.2 to 2.1 (>90% reduction) and five of the seven had no bleeds
for 50 days at their final dose. The Company’s interim data
indicates MarzAA is safe and well tolerated. Subcutaneous half-life
increased to 13.1 hours compared with intravenous half-life of 3.9
hours.
- Dalcinonacog alfa – DalcA, subcutaneously
administered next-generation engineered coagulation Factor IX:
Completed a Phase 1/2 subcutaneous dosing trial. The trial
evaluated the safety and efficacy of DalcA in individuals with
severe hemophilia B. Data from the study demonstrated that DalcA is
highly efficacious, achieving activity levels well above that
required for prevention of spontaneous bleeding. Two subjects
developed neutralizing antibodies, one transiently, that did not
interfere with their ability for continued use of other FIX
products. The Company completed a full investigation and concluded
that DalcA has a similar low immunogenicity potential as do BeneFIX
and other commercial wildtype Factor IX products. The Company is
moving forward in clinical development of DalcA and will start a
Phase 2b trial in March 2019, enrolling up to six patients each
with 28 days of dosing.
- DalcA: Amended the ISU Abxis license and
collaboration agreement to replace the original profit-sharing
arrangement with a low single-digit royalty, on a
country-by-country basis, for net product sales of DalcA by the
Company or its affiliates in each country other than South
Korea.
- CB 2679d-GT – Factor IX Gene Therapy:
Demonstrated 3-fold superior clotting activity and a 4 to 5-fold
reduction in bleeding time in a hemophilia B mouse model of AAV
gene therapy delivery containing the DalcA sequence compared with a
gene therapy construct containing the Padua variant, that is the
current lead clinical variant in development.
- Financial: Strong cash and short-term
investments balance of $120.1 million, which positions the Company
to fund the clinical development of the MarzAA and DalcA
programs.
Expected Milestones
- Complete the MarzAA Phase 2 open-label subcutaneous efficacy
trial with topline data read out in Q3 2019 and final data read out
in Q4 2019; initiate a MarzAA Phase 1 PK/PD study in Q2 2019 with
final data read out in Q4 2019; initiate an End of Phase 2 meeting
with the FDA in Q4 2019
- Initiate a DalcA Phase 2b study in Q1 2019 with topline data
readout in Q3 2019 and final data readout in Q4 2019
- Demonstrate prolonged PK/PD for the anti-C3 protease in the
dAMD program in Q2 2019
Fourth Quarter and Full-year 2018
Results and Financial Highlights
- Cash, cash equivalents and short-term investments, as of
December 31, 2018 were $120.1 million due primarily to the
approximately $106.8 million in net financing in February 2018 and
$9.5 million in proceeds from the exercise of warrants during the
first quarter 2018.
- Research and development expense for the three-months and
full-year ended December 31, 2018 was $8.2 million and $21.5
million, respectively, compared with $3.6 million and $12.8 million
for the prior year periods, respectively. The increase was due
primarily to investments in the development of the MarzAA and DalcA
clinical programs.
- General and administrative expense for the three-months and
year-ended December 31, 2018 was $3.4 million and $12.4 million,
respectively, compared with $2.6 million and $10.0 million for the
prior year periods, respectively. The increase was due primarily to
increases in personnel and non-cash stock-based compensation
expense.
- Interest and other income for the three-months and the year
ended December 31, 2018 was $0.8 million and $3.8 million,
respectively, compared with $0.1 million and $0.3 million for the
prior year periods, respectively. Interest income increased by $2.0
million in 2018 due to the higher cash balances from the financing
and the exercise of warrants. The Company also received a $1.5
million milestone payment under an asset sale agreement in
2018.
- Net loss attributable to common stockholders for the
three-months and year-ended December 31, 2018 was $10.9 million, or
($0.91) per basic and diluted share, and $30.1 million, or ($2.68)
per basic and diluted share, respectively, compared with $5.8
million, or ($1.26) per basic and diluted share, and $25.5 million,
or ($7.45) per basic and diluted share, for the prior year periods,
respectively.
- On February 19, 2018, the final $5.1 million of the Company’s
redeemable convertible notes matured and were repaid in full.
- As of December 31, 2018, the Company had 11,954,528 shares of
common stock outstanding.
About Catalyst
BiosciencesCatalyst is a clinical-stage biopharmaceutical
company focused on developing novel medicines to address serious
medical conditions for individuals who need new or better treatment
options. We are focusing our product development efforts in the
field of hemostasis (the process that regulates bleeding) and have
a mission to develop valuable therapies for individuals with
hemophilia. For more information, please visit
www.catalystbiosciences.com.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. Forward-looking statements
include statements about the potential commercial market for DalcA
and MarzAA, the relative safety of DalcA compared with BeneFIX and
other recombinant Factor IX products, Catalyst’s plans to commence
a Phase 2b clinical trial of DalcA in March 2019 and have top-line
and final data readouts in Q3 and Q4, 2019, respectively, the
potential for DalcA to provide a conveniently-dosed subcutaneous
prophylactic treatment option for patients suffering from
hemophilia B, the potential for MarzAA to provide prophylaxis
therapy in patients with hemophilia A or B with inhibitors, and
plans to complete the Phase 2 clinical trial and a Phase 1 PK/PD
study of MarzAA in 2019. Forward looking statements also include
Catalyst’s plans to determine preclinical efficacy for CB 2679d-GT
in 2019 and develop CB2782 towards a pre-clinical candidate in
2019. 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 from the
forward-looking statements that the Company makes, including, but
not limited to, the risk that trials and studies may be delayed and
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 or
DalcA, including the generation of antibodies, which has been
observed in patients treated with DalcA, the risk that costs
required to develop or manufacture the Company’s products will be
higher than anticipated, competition and other factors that affect
our ability to establish collaborations on commercially reasonable
terms and other risks described in the “Risk Factors” section of
the Company’s Annual Report on Form 10-K for the quarter and the
year ended December 31, 2018 filed with
the Securities and Exchange Commission on March 7,
2019, and with 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.
Contacts:Investors:Fletcher
Payne, CFOCatalyst Biosciences,
Inc.1.650.871.0761investors@catbio.com
Media:Josephine Belluardo,
Ph.D.LifeSci Public
Relations1.646.751.4361jo@lifescipublicrelations.com
|
Catalyst Biosciences, Inc. |
Consolidated Balance Sheets |
(In thousands, except shares and per share
amounts) |
|
|
|
December 31, 2018 |
|
|
December 31, 2017 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
31,213 |
|
|
$ |
14,472 |
|
Short-term investments |
|
|
88,914 |
|
|
|
17,971 |
|
Restricted cash |
|
|
50 |
|
|
|
5,333 |
|
Prepaid
and other current assets |
|
|
3,814 |
|
|
|
1,333 |
|
Total
current assets |
|
|
123,991 |
|
|
|
39,109 |
|
Other assets,
noncurrent |
|
|
543 |
|
|
|
128 |
|
Property and equipment,
net |
|
|
386 |
|
|
|
276 |
|
Total
assets |
|
$ |
124,920 |
|
|
$ |
39,513 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,248 |
|
|
$ |
747 |
|
Accrued
compensation |
|
|
1,495 |
|
|
|
1,366 |
|
Other
accrued liabilities |
|
|
2,043 |
|
|
|
1,322 |
|
Deferred
revenue, current portion |
|
|
— |
|
|
|
212 |
|
Deferred
rent, current portion |
|
|
15 |
|
|
|
7 |
|
Redeemable convertible notes |
|
|
— |
|
|
|
5,085 |
|
Total
current liabilities |
|
|
4,801 |
|
|
|
8,739 |
|
Deferred rent,
noncurrent portion |
|
|
174 |
|
|
|
— |
|
Total liabilities |
|
|
4,975 |
|
|
|
8,739 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares authorized; 0 and 3,680
shares issued and outstanding at December 31, 2018 and 2017,
respectively |
|
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value, 100,000,000 shares authorized; 11,954,528
and 6,081,230 shares issued and outstanding at December 31, 2018
and 2017, respectively |
|
|
12 |
|
|
|
6 |
|
Additional paid-in capital |
|
|
323,279 |
|
|
|
204,262 |
|
Accumulated other comprehensive loss |
|
|
(4 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(203,342 |
) |
|
|
(173,494 |
) |
Total
stockholders’ equity |
|
|
119,945 |
|
|
|
30,774 |
|
Total
liabilities and stockholders’ equity |
|
$ |
124,920 |
|
|
$ |
39,513 |
|
Catalyst Biosciences, Inc. |
Consolidated Statements of
Operations |
(In thousands, except shares and per share
amounts) |
|
|
|
Year Ended December 31, |
|
|
|
2018 |
|
|
2017 |
|
Contract revenue |
|
$ |
6 |
|
|
$ |
1,018 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
21,474 |
|
|
|
12,847 |
|
General
and administrative |
|
|
12,354 |
|
|
|
9,993 |
|
Total
operating expenses |
|
|
33,828 |
|
|
|
22,840 |
|
Loss from
operations |
|
|
(33,822 |
) |
|
|
(21,822 |
) |
Interest and other
income, net |
|
|
3,767 |
|
|
|
261 |
|
Net loss |
|
|
(30,055 |
) |
|
|
(21,561 |
) |
Deemed dividend for
convertible preferred stock beneficial conversion feature |
|
|
- |
|
|
|
(3,951 |
) |
Net loss attributable
to common stockholders |
|
$ |
(30,055 |
) |
|
$ |
(25,512 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(2.68 |
) |
|
$ |
(7.45 |
) |
Shares used to compute
net loss per share attributable to common stockholders, basic and
diluted |
|
|
11,213,884 |
|
|
|
3,423,901 |
|
|
Catalyst Biosciences (NASDAQ:CBIO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Catalyst Biosciences (NASDAQ:CBIO)
Historical Stock Chart
From Apr 2023 to Apr 2024