Catalyst Biosciences Reports First Quarter 2017 Financial Results and Provides Corporate Update
May 11 2017 - 8:01AM
-- Raised ~$20 million through an
underwritten equity offering --
Catalyst Biosciences, Inc. (NASDAQ:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, today announced financial results
for the first quarter ended March 31, 2017.
“During the first quarter of this year we made significant
progress with completion of the IND-enabling preclinical studies
for our subcutaneous Factor IX program,” said Nassim Usman, Ph.D.,
Catalyst’s President and Chief Executive Officer. “With the IND
approval in South Korea for our subcutaneous Factor IX candidate,
CB 2679d/ISU304, we look forward to the initiation a Phase 1/2
proof-of-concept clinical trial in individuals with severe
hemophilia B this quarter with the goal of providing a therapy with
a simpler dosing method and improved long-term clinical
outcomes.”
Recent Highlights
- Raised $20.7 million through an underwritten public equity
offering that included the full exercise of the underwriters’
over-allotment option to purchase additional shares and warrants on
April 12, 2017
- Achieved key milestones with CB 2679d/ISU304, the Company’s
next-generation coagulation Factor IX, as follows:
- Investigational New Drug (IND) application approved by the
Korean Ministry of Food and Drug Safety (MFDS)
- Completion of IND-enabling toxicology studies triggered a
milestone payment from Catalyst’s collaboration partner, ISU
Abxis
- Advanced the development of marzeptacog alfa (activated), the
Company’s next-generation Factor VIIa, including the following
accomplishments:
- Received notice from the European Patent Office that the
opposition period, for a patent granted to Catalyst, has expired
and no opposition has been filed
- Selected a global contract research organization, INC Research,
to conduct the Phase 2/3 efficacy clinical trial of marzeptacog
alfa (activated) in individuals with hemophilia A or B with an
inhibitor
Anticipated Milestones
- CB 2679d/ISU304: Initiate a Phase 1/2
proof-of-concept clinical trial in individuals with severe
hemophilia B in the second quarter of 2017; the trial will be
conducted by Catalyst’s collaborator, ISU Abxis (KOSDAQ: 086890) in
South Korea
- Marzeptacog alfa (activated): Initiate the
Phase 2 part of a Phase 2/3 efficacy clinical trial in individuals
with hemophilia A or B with an inhibitor in the fourth quarter of
2017
Financial Results for the First Quarter and Year Ended
March 31, 2017
- Contract revenue for the three months ended March 31, 2017 was
$0.3 million, compared with $0.1 million for the prior year period.
The increase in contract revenue was due to the milestone revenue
from ISU Abxis of $0.2 million.
- Research and development expense for the three months ended
March 31, 2017 was $2.1 million, compared with $2.3 million for the
prior year period. The decrease was due primarily to a decrease in
personnel-related costs in connection with a reduction in workforce
in 2016.
- General and administrative expense for the three months ended
March 31, 2017 was $2.4 million, which was flat compared with the
prior year period.
- Interest and other income for the three months ended March 31,
2017 was $0.03 million, compared with $1.0 million for the prior
year period. The decrease was due primarily to a $1.0 million gain
recognized in 2016 related to the change in fair value of the
derivative liability in 2016.
- Net loss for the three months ended March 31, 2017 was $4.1
million, or ($4.57) per basic and diluted share, compared with $3.6
million, or ($4.71) per basic and diluted share, for the prior year
period.
- Cash, cash equivalents and short-term investments as of March
31, 2017 were $14.5 million, not including the $20.7 million raised
through the underwritten public equity offering and $3.5 million
raised through the Company’s at-the-market offering program with
JonesTrading. The Company believes that its existing capital
resources will be sufficient to meet its projected operating
requirements for at least the next 12 months.
- As of March 31, 2017, there were approximately 1.0 million
shares of common stock and as of May 4, 2017, the Company had
approximately 4.26 million shares of common stock and 5,750 shares
of preferred stock (convertible into an aggregate of 1.15 million
shares of common stock).
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. Catalyst’s most advanced program is an improved
next-generation coagulation Factor VIIa variant, marzeptacog alfa
(activated), that has successfully completed an intravenous Phase 1
clinical trial in individuals with severe hemophilia A or B.
Catalyst is also developing a next-generation Factor IX variant, CB
2679d/ISU304, that is IND-approved in South Korea. 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 statement of
historical facts, included in this press release regarding our
strategy, future operations, and plans are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to Catalyst’s clinical trial
timelines, including the anticipated initiation of a Phase 1/2
clinical trial for Factor IX CB 2679d/ISU304 in the second quarter
of 2017 and the entry of marzeptacog alfa (activated) into a
subcutaneous efficacy trial in 2017, the potential uses and
benefits of subcutaneously dosed marzeptacog alfa (activated) and
CB 2679d/ISU304, 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 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) |
|
|
|
|
|
March 31, 2017 |
|
|
December 31, 2016 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
14,533 |
|
|
$ |
10,264 |
|
Short-term investments |
|
|
— |
|
|
|
6,800 |
|
Restricted cash |
|
|
12,735 |
|
|
|
19,468 |
|
Accounts
receivable |
|
|
227 |
|
|
|
31 |
|
Prepaid
and other current assets |
|
|
1,041 |
|
|
|
958 |
|
Total
current assets |
|
|
28,536 |
|
|
|
37,521 |
|
Restricted cash,
noncurrent |
|
|
125 |
|
|
|
125 |
|
Property and equipment,
net |
|
|
399 |
|
|
|
444 |
|
Total
assets |
|
$ |
29,060 |
|
|
$ |
38,090 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
899 |
|
|
$ |
837 |
|
Accrued
compensation |
|
|
645 |
|
|
|
596 |
|
Other
accrued liabilities |
|
|
730 |
|
|
|
805 |
|
Deferred
revenue, current portion |
|
|
259 |
|
|
|
283 |
|
Deferred
rent, current portion |
|
|
40 |
|
|
|
41 |
|
Redeemable convertible notes |
|
|
12,651 |
|
|
|
19,403 |
|
Total
current liabilities |
|
|
15,224 |
|
|
|
21,965 |
|
Deferred revenue,
noncurrent portion |
|
|
— |
|
|
|
47 |
|
Deferred rent,
noncurrent portion |
|
— |
|
|
|
7 |
|
Total liabilities |
|
|
15,224 |
|
|
|
22,019 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares and no shares authorized
and outstanding at both March 31, 2017 and December 31,
2016 |
|
|
— |
|
|
— |
|
Common
stock, $0.001 par value, 100,000,000 shares authorized; 1,000,036
and 801,756 shares issued and outstanding at March 31, 2017
and December 31, 2016 |
|
|
2 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
165,954 |
|
|
|
164,053 |
|
Accumulated other comprehensive income (loss) |
|
|
— |
|
|
|
(1 |
) |
Accumulated deficit |
|
|
(152,120 |
) |
|
|
(147,982 |
) |
Total
stockholders’ equity |
|
|
13,836 |
|
|
|
16,071 |
|
Total
liabilities and stockholders’ equity |
|
$ |
29,060 |
|
|
$ |
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 March 31, |
|
|
|
2017 |
|
|
2016 |
|
Contract revenue |
|
$ |
271 |
|
|
$ |
109 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
2,061 |
|
|
|
2,286 |
|
General
and administrative |
|
|
2,381 |
|
|
|
2,395 |
|
Total
operating expenses |
|
|
4,442 |
|
|
|
4,681 |
|
Loss from
operations |
|
|
(4,171 |
) |
|
|
(4,572 |
) |
Interest and other
income, net |
|
|
33 |
|
|
|
980 |
|
Net loss |
|
$ |
(4,138 |
) |
|
$ |
(3,592 |
) |
Net loss per common
share, basic and diluted |
|
$ |
(4.57 |
) |
|
$ |
(4.71 |
) |
Shares used to compute
net loss per common share, basic and diluted |
|
|
906,048 |
|
|
|
762,007 |
|
|
|
The
accompanying notes are an integral part of these condensed
consolidated financial statements. |
|
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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