Catalyst Biosciences Reports Second Quarter 2017 Financial Results and Provides Subcutaneous (SQ) Hemophilia Program Update
August 03 2017 - 8:00AM
-- Enrollment into Phase 1/2 trial of Factor IX
SQ candidate CB 2679d is ongoing; trial is on track to announce
interim results by year-end --
Catalyst Biosciences, Inc. (NASDAQ:CBIO), today announced financial
results for the second quarter ended June 30, 2017 and provided a
corporate update.
Recent Milestones: Factor IX SQ CB 2679d (also known as
ISU304)
- Initiated and completed dosing of first patient cohort in Phase
1/2 clinical trial of subcutaneous (SQ) CB 2679d in individuals
with hemophilia B;
- Received a $0.7M milestone payment from Catalyst’s
collaborator, ISU Abxis, for initiation of the Phase 1/2 clinical
trial;
- Presented positive preclinical results at an international
hemophilia meeting (ISTH) that demonstrate the ability to normalize
Factor IX levels in a model of hemophilia B with daily SQ dosing;
and
- Received Orphan Medicine Designation from the European
Commission for the treatment of individuals with hemophilia B with
SQ CB 2679d.
Recent Milestones: Factor VIIa/marzeptacog alfa
(activated)
- Presented positive preclinical results at ISTH of Catalyst’s
subcutaneously administered Factor VIIa, marzeptacog alfa
(activated), that support the initiation of a Phase 2/3 clinical
trial to evaluate subcutaneous dosing as prophylaxis for
individuals with hemophilia and an inhibitor.
“We made significant progress in both our clinical programs and
strengthened our balance sheet in the second quarter” said Nassim
Usman, Ph.D., Catalyst’s President and Chief Executive Officer.
“The Factor IX program was initiated on schedule and we expect to
report interim results from the Phase 1/2 subcutaneous dosing study
in individuals with hemophilia B by year-end. We also intend to
initiate a Phase 2 clinical trial for our Factor VIIa product
candidate Marzeptacog alfa by the end of the year. With the
additional capital we raised in April, we are well positioned to
report clinical data from both programs over the next 12
months.”
2017 Anticipated Milestones
- Factor IX/CB 2679d: Announce interim results
from the SQ Phase 1/2 proof-of-concept clinical trial in
individuals with severe hemophilia B by the end of 2017; and
- Factor VIIa/marzeptacog alfa (activated):
Initiate the Phase 2 part of a Phase 2/3 SQ efficacy clinical trial
in individuals with hemophilia A or B with an inhibitor by the end
of 2017.
2017 Financial Highlights
- Raised $26 million through the six months ended June 30, 2017
consisting of $20.7 million raised through the underwritten public
equity offering and $5.3 million raised through our Capital on
DemandTM program. Cash, cash equivalents and short-term investments
as of June 30, 2017 were $32.4 million (excluding restricted cash).
The Company believes that its existing capital resources will be
sufficient to meet its projected operating requirements for at
least the next 12 months.
- Redeemable Convertible Notes balance was reduced to $5.8
million from $19.4 million at December 2016; all redemptions were
funded from the restricted cash, of which an additional $5.8
million is available to fund the remaining notes.
- Research and development expense for the three months ended
June 30, 2017 was $3.4 million, compared with $2.8 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
costs and costs related to preclinical third-party research and
development service contracts.
- General and administrative expense for the three months ended
June 30, 2017 was $2.7 million, compared with $2.3 million for the
prior year period. The increase was due primarily to an increase in
personnel-related costs and an increase in professional service
costs indirectly related to the underwritten public offering.
- Net loss attributable to common stockholders for the three
months ended June 30, 2017 was $9.8 million, or ($2.53) per basic
and diluted share, compared with $4.8 million, or ($6.33) per basic
and diluted share, for the prior year period. Convertible
preferred stock’s $4.0 million deemed dividend is a non-cash,
non-recurring charge.
About Catalyst Biosciences Catalyst is a
clinical-stage biopharmaceutical company focused on 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 alpha (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 study for marzeptacog alfa (activated) in 2017,
the anticipated completion of a Phase 1/2 proof-of-concept study
for CB 2679d or the plans to have results from this study by the
end of 2017, the 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.
Catalyst Biosciences, Inc. |
Condensed Consolidated Balance
Sheets |
(In thousands, except share and per share amounts) |
|
|
June 30, 2017 |
|
|
December 31, 2016 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
32,388 |
|
|
$ |
10,264 |
|
Short-term investments |
|
|
— |
|
|
|
6,800 |
|
Restricted cash |
|
|
5,997 |
|
|
|
19,468 |
|
Accounts
receivable |
|
|
135 |
|
|
|
31 |
|
Prepaid
and other current assets |
|
|
752 |
|
|
|
958 |
|
Total
current assets |
|
|
39,272 |
|
|
|
37,521 |
|
Restricted cash,
noncurrent |
|
|
— |
|
|
|
125 |
|
Property and equipment,
net |
|
|
358 |
|
|
|
444 |
|
Total
assets |
|
$ |
39,630 |
|
|
$ |
38,090 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
501 |
|
|
$ |
837 |
|
Accrued
compensation |
|
|
676 |
|
|
|
596 |
|
Other
accrued liabilities |
|
|
1,460 |
|
|
|
805 |
|
Deferred
revenue, current portion |
|
|
848 |
|
|
|
283 |
|
Deferred
rent, current portion |
|
|
29 |
|
|
|
41 |
|
Redeemable convertible notes |
|
|
5,770 |
|
|
|
19,403 |
|
Total
current liabilities |
|
|
9,284 |
|
|
|
21,965 |
|
Deferred revenue,
noncurrent portion |
|
|
— |
|
|
|
47 |
|
Deferred rent,
noncurrent portion |
|
— |
|
|
|
7 |
|
Total liabilities |
|
|
9,284 |
|
|
|
22,019 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares authorized; 5,500 and 0
shares issued and outstanding at June 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 June 30, 2017
and December 31, 2016, respectively |
|
|
4 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
192,290 |
|
|
|
164,053 |
|
Accumulated other comprehensive (loss) |
|
|
— |
|
|
|
(1 |
) |
Accumulated deficit |
|
|
(161,948 |
) |
|
|
(147,982 |
) |
Total
stockholders’ equity |
|
|
30,346 |
|
|
|
16,071 |
|
Total
liabilities and stockholders’ equity |
|
$ |
39,630 |
|
|
$ |
38,090 |
|
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, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Contract revenue |
|
$ |
111 |
|
|
$ |
109 |
|
|
$ |
382 |
|
|
$ |
219 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
3,401 |
|
|
|
2,752 |
|
|
|
5,481 |
|
|
|
5,046 |
|
General
and administrative |
|
|
2,654 |
|
|
|
2,272 |
|
|
|
5,017 |
|
|
|
4,658 |
|
Total
operating expenses |
|
|
6,055 |
|
|
|
5,024 |
|
|
|
10,498 |
|
|
|
9,704 |
|
Loss from
operations |
|
|
(5,944 |
) |
|
|
(4,915 |
) |
|
|
(10,116 |
) |
|
|
(9,485 |
) |
Interest and other
income, net |
|
|
67 |
|
|
|
82 |
|
|
|
101 |
|
|
|
1,061 |
|
Net loss |
|
|
(5,877 |
) |
|
|
(4,833 |
) |
|
|
(10,015 |
) |
|
|
(8,424 |
) |
Deemed dividend for
convertible preferred stock beneficial conversion feature |
|
|
(3,951 |
) |
|
|
— |
|
|
|
(3,951 |
) |
|
|
— |
|
Net loss attributable
to common stockholders |
|
$ |
(9,828 |
) |
|
$ |
(4,833 |
) |
|
$ |
(13,966 |
) |
|
$ |
(8,424 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(2.53 |
) |
|
$ |
(6.33 |
) |
|
$ |
(5.82 |
) |
|
$ |
(11.05 |
) |
Shares used to compute
net loss per share attributable to common stockholders, basic and
diluted |
|
|
3,877,736 |
|
|
|
763,138 |
|
|
|
2,400,101 |
|
|
|
762,573 |
|
Contacts:
Investors:
Fletcher Payne, CFO
Catalyst Biosciences, Inc.
+1.650.871.0761
investors@catbio.com
Media:
Denise Powell
Red House Consulting, LLC
+1.510.703.9491
denise@redhousecomms.com
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