Catalyst Biosciences Reports Third Quarter 2017 Operating & Financial Results and Provides Corporate Update
November 02 2017 - 8:30AM
-- Phase 1/2 trial of Factor IX CB 2679d is
advancing with interim results expected by year-end --
Catalyst Biosciences, Inc. (NASDAQ:CBIO), today announced operating
and financial results for the third quarter ended Sept. 30, 2017,
and provided a corporate update.
Recent Milestones: Factor IX CB 2679d product candidate
(also known as ISU304)
- Successfully completed dosing of the first and second cohorts
of the Phase 1/2 clinical trial. The second cohort included
the first subcutaneous dosing of individuals with hemophilia
B;
- Demonstrated 22-fold higher potency and improved
pharmacokinetics of CB 2679d compared with BeneFIX™ with
intravenous dosing in the first patient cohort of the Phase 1/2
clinical trial in individuals with hemophilia B;
- Granted orphan drug designation for CB 2679d for the treatment
of hemophilia B from the U.S. Food and Drug Administration;
and
- Received patents covering both modified Factor IX polypeptides
and uses thereof for CB 2679d in the People's Republic of China,
Singapore and Taiwan.
“We have made steady progress with the clinical
development of our coagulation Factor IX hemophilia product
candidate, and we look forward to presenting interim results from
the ongoing Phase 1/2 subcutaneous dosing study in individuals with
hemophilia B at the American Society of Hematology on Dec. 9, as we
announced yesterday” said Nassim Usman, Ph.D., president and chief
executive officer of Catalyst. “This is an exciting time for the
company as we continue towards near-term data milestones and
longer-term program development for both our Factor IX and FVIIa
programs.”
Upcoming Milestones
- Present interim results from the subcutaneous Factor IX CB
2679d Phase 1/2 proof-of-concept clinical trial in individuals with
severe hemophilia B in an oral presentation on Dec. 9, 2017 at the
American Hematological Society Conference in Atlanta, GA;
- Initiate the Factor VIIa marzeptacog alfa (activated) Phase 2
part of a Phase 2/3 subcutaneous efficacy clinical trial in
individuals with hemophilia A or B with an inhibitor by the end of
2017;
- Announce top-line multi-dose results from the subcutaneous
Factor IX CB 2679d Phase 1/2 proof-of-concept clinical trial in
individuals with severe hemophilia B by Q1 of 2018; and
- Announce interim results from the Factor VIIa marzeptacog alfa
(activated) Phase 2 clinical trial in individuals with hemophilia A
or B with an inhibitor in the first half 2018.
Third Quarter 2017 Financial Highlights
- Cash, cash equivalents and short-term investments, as of Sept.
30, 2017, were $27.5 million. The Company believes that its
existing capital resources will be sufficient to meet its projected
operating requirements for at least the next 12 months.
- Research and development expenses for the three months ended
Sept. 30, 2017 were $3.8 million, compared with $3.4 million for
the prior year period. The increase was due primarily to
manufacturing expenses for marzeptacog alfa (activated), partially
offset by a decrease in personnel-related costs and a decrease in
lab supply and facility costs.
- General and administrative expense was $2.4 million for both
the three months ended Sept. 30, 2017 and 2016.
- Net loss attributable to common stockholders for the three
months ended Sept. 30, 2017 was $5.8 million, or ($1.34) per basic
and diluted share, compared with $4.8 million, or ($6.04) per basic
and diluted share, for the prior year period.
About Catalyst BiosciencesCatalyst is a
clinical-stage biopharmaceutical company developing novel medicines
to address hematology indications. Catalyst is focused on the field
of hemostasis, including the subcutaneous prophylaxis of hemophilia
and facilitating surgery in individuals with hemophilia.
For more information, please visit
www.catbio.com.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release
regarding our strategy, the potential uses and benefits of CB 2679d
and marzeptacog alfa (activated) and development plans for these
product candidates are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
Catalyst’s clinical trial timelines, including the initiation of a
Phase 2/3 efficacy trial for marzeptacog alfa (activated) in 2017,
the anticipated announcement of top-line results from the
subcutaneous CB 2679d Phase 1/2 proof-of-concept trial by the first
quarter of 2018, the anticipated announcement of interim results
from the marzeptacog alpha (activated) Phase 2 clinical trial in
the first half of 2018, potential uses and benefits of
subcutaneously dosed marzeptacog alfa (activated) or CB 2679d, and
the Company’s belief regarding sufficiency of its existing capital
resources to meet its projected operating requirements for at least
the next 12 months. 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 Catalyst makes, including,
but not limited to, the risk that clinical trials and studies may
be delayed and may not have satisfactory outcomes, that potential
adverse effects may arise from the testing or use of Catalyst’s
products, the risk that costs required to develop or manufacture
Catalyst’s products will be higher than anticipated, competition
and other factors that affect our ability to successfully develop
and commercialize our product candidates, and other risks described
in the “Risk Factors” section of the Company’s Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Catalyst does not assume any obligation to update any
forward-looking statements, except as required by law.
Contacts:
Investors:
Fletcher Payne,
CFO
Catalyst Biosciences,
Inc.
1.650.871.0761
investors@catbio.com
MediaJosephine Belluardo,
Ph.D.LifeSci Public
Relations1.646.751.4361jo@lifescipublicrelations.com
Catalyst Biosciences, Inc. |
Condensed Consolidated Balance
Sheets |
(In thousands, except share and per share amounts) |
|
|
September 30, 2017 |
|
|
December 31, 2016 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
10,973 |
|
|
$ |
10,264 |
|
Short-term investments |
|
|
16,477 |
|
|
|
6,800 |
|
Restricted cash |
|
|
5,727 |
|
|
|
19,468 |
|
Accounts
receivable |
|
|
52 |
|
|
|
31 |
|
Prepaid
and other current assets |
|
|
849 |
|
|
|
958 |
|
Total
current assets |
|
|
34,078 |
|
|
|
37,521 |
|
Restricted cash,
noncurrent |
|
|
— |
|
|
|
125 |
|
Property and equipment,
net |
|
|
315 |
|
|
|
444 |
|
Total
assets |
|
$ |
34,393 |
|
|
$ |
38,090 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,460 |
|
|
$ |
837 |
|
Accrued
compensation |
|
|
920 |
|
|
|
596 |
|
Other
accrued liabilities |
|
|
1,095 |
|
|
|
805 |
|
Deferred
revenue, current portion |
|
|
530 |
|
|
|
283 |
|
Deferred
rent, current portion |
|
|
18 |
|
|
|
41 |
|
Redeemable convertible notes |
|
|
5,488 |
|
|
|
19,403 |
|
Total
current liabilities |
|
|
9,511 |
|
|
|
21,965 |
|
Deferred revenue,
noncurrent portion |
|
|
— |
|
|
|
47 |
|
Deferred rent,
noncurrent portion |
|
|
— |
|
|
|
7 |
|
Total liabilities |
|
|
9,511 |
|
|
|
22,019 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares authorized; 5,500 and 0
shares issued and outstanding at September 30, 2017 and December
31, 2016, respectively |
|
|
— |
|
|
— |
|
Common
stock, $0.001 par value, 100,000,000 shares authorized; 4,310,561
and 801,756 shares issued and outstanding at September 30,
2017 and December 31, 2016, respectively |
|
|
4 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
192,615 |
|
|
|
164,053 |
|
Accumulated other comprehensive income (loss) |
|
|
4 |
|
|
|
(1 |
) |
Accumulated deficit |
|
|
(167,741 |
) |
|
|
(147,982 |
) |
Total
stockholders’ equity |
|
|
24,882 |
|
|
|
16,071 |
|
Total
liabilities and stockholders’ equity |
|
$ |
34,393 |
|
|
$ |
38,090 |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of
these condensed consolidated financial statements.
Catalyst Biosciences, Inc. |
|
|
|
|
Condensed Consolidated Statements of
Operations |
|
|
|
|
(In thousands, except share and per share amounts) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
Three Months Ended
September 30, |
|
|
Nine Months Ended
September 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Contract revenue |
|
$ |
318 |
|
|
$ |
109 |
|
|
$ |
700 |
|
|
$ |
328 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
3,805 |
|
|
|
3,396 |
|
|
|
9,286 |
|
|
|
8,443 |
|
General
and administrative |
|
|
2,391 |
|
|
|
2,425 |
|
|
|
7,407 |
|
|
|
7,083 |
|
Total
operating expenses |
|
|
6,196 |
|
|
|
5,821 |
|
|
|
16,693 |
|
|
|
15,526 |
|
Loss from
operations |
|
|
(5,878 |
) |
|
|
(5,712 |
) |
|
|
(15,993 |
) |
|
|
(15,198 |
) |
Interest and other
income, net |
|
|
85 |
|
|
|
941 |
|
|
|
185 |
|
|
|
2,003 |
|
Net loss |
|
|
(5,793 |
) |
|
|
(4,771 |
) |
|
|
(15,808 |
) |
|
|
(13,195 |
) |
Deemed dividend for
convertible preferred stock beneficial conversion feature |
|
|
- |
|
|
|
— |
|
|
|
(3,951 |
) |
|
|
— |
|
Net loss attributable
to common stockholders |
|
$ |
(5,793 |
) |
|
$ |
(4,771 |
) |
|
$ |
(19,759 |
) |
|
$ |
(13,195 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(1.34 |
) |
|
$ |
(6.04 |
) |
|
$ |
(6.49 |
) |
|
$ |
(17.10 |
) |
Shares used to compute
net loss per share attributable to common stockholders, basic and
diluted |
|
|
4,310,561 |
|
|
|
789,796 |
|
|
|
3,043,919 |
|
|
|
771,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of
these condensed consolidated financial statements.
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