Catalyst Biosciences Reports Third Quarter 2016 Financial Results and Provides Corporate Update
November 03 2016 - 8:00AM
-- Subcutaneous Phase 1/2 Proof-of-Concept
Clinical Trial of High Potency Factor IX CB 2679d/ISU304 in
individuals with Hemophilia B to Commence in the First Quarter of
2017 --
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 third quarter ended September 30, 2016.
“During the third quarter, we refocused the Company
on developing our highly potent next-generation Factor VIIa and IX
programs using subcutaneous dosing. We and our collaborator ISU
Abxis of South Korea remain on track to initiate a Phase 1/2
clinical trial for our next-generation Factor IX CB 2679d/ISU304 in
the first quarter of 2017,” said Nassim Usman, Ph.D., Catalyst’s
President and Chief Executive Officer. “Since all currently
approved hemophilia drugs are infused intravenously, they have
significant limitations regarding convenient dosing and the ability
to maintain suitable levels of factor activity. We believe that a
subcutaneously injected therapy that consistently maintains high
factor levels may provide a simpler dosing method and improved
long-term clinical outcomes for patients.”
Recent Highlights
- Refocused the Company on development stage programs Factor VIIa
and IX to provide convenient subcutaneous prophylaxis to
individuals with hemophilia.
- Demonstrated the feasibility of subcutaneous dosing of Factor
IX CB 2679d/ISU304 and marzeptacog alfa (activated) in multiple
hemophilia animal models.
- Entered into a definitive sales agreement to sell an additional
neuronal nicotinic receptor (“NNR”) asset that represents a portion
of the NNR assets that were under development by Targacept prior to
its 2015 merger with Catalyst; earned a $750,000 upfront payment
and the potential for future milestones and royalties.
Anticipated Milestones
- CB 2679d/ISU304, the Company’s high potency Factor IX for
hemophilia B, is expected to enter a Phase 1/2 proof of concept
subcutaneous trial in the first quarter of 2017.
- The trial will be conducted by Catalyst’s collaborator, ISU
Abxis (KOSDAQ: 086890) in South Korea.
- Marzeptacog alfa (activated), the Company’s next-generation
coagulation Factor VIIa variant, for individuals with hemophilia A
or B and an inhibitor, is expected to enter a subcutaneous efficacy
of prophylaxis trial in 2017.
Financial Results for the Third Quarter Ended September
30, 2016
- Contract revenue for the three months ended September 30, 2016
and 2015 was $0.1 million.
- Research and development expense for the three months ended
September 30, 2016 was $3.4 million, compared to $1.5 million for
the prior year period. The increase was due primarily to increased
manufacturing expenses for marzeptacog alfa (activated), personnel
costs related to the Company’s September 2016 reduction in
workforce and an increase in lab supply costs and costs related to
preclinical third-party R&D service contracts.
- General and administrative expense for the three months ended
September 30, 2016 was $2.4 million, compared to $2.5 million for
the prior year period. The decrease was due primarily to a decrease
in the cost of professional services.
- Interest and other income for the three months ended September
30, 2016 was $0.9 million, compared to $0.3 million for the
comparable period in the prior year. The increase was due primarily
to the gain related to the sale of NNR assets.
- Net loss for the three months ended September 30, 2016 was $4.8
million, or ($0.40) per basic and diluted share, compared to $5.1
million, or ($0.93) per basic and diluted share for the prior year
period.
- Cash, cash equivalents and short-term investments as of
September 30, 2016 were $19.5 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.
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 in advanced preclinical
development. For more information, please visit
www.catalystbiosciences.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 first
quarter of 2017 and the entry of marzeptacog alfa (activated) into
a subcutaneous efficacy of prophylaxis 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 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) |
|
|
|
September 30, 2016 |
|
|
December 31,2015 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,317 |
|
|
$ |
29,096 |
|
Short-term investments |
|
|
10,208 |
|
|
|
3,402 |
|
Restricted cash |
|
|
29,719 |
|
|
|
33,794 |
|
Deposits |
|
|
5 |
|
|
|
133 |
|
Accounts receivable |
|
|
101 |
|
|
|
492 |
|
Prepaid and other current
assets |
|
|
1,425 |
|
|
|
1,781 |
|
Total current assets |
|
|
50,775 |
|
|
|
68,698 |
|
Restricted cash,
noncurrent |
|
|
125 |
|
|
|
125 |
|
Property and equipment,
net |
|
|
716 |
|
|
|
698 |
|
Total
assets |
|
$ |
51,616 |
|
|
$ |
69,521 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
529 |
|
|
$ |
939 |
|
Accrued compensation |
|
|
682 |
|
|
|
926 |
|
Other accrued liabilities |
|
|
652 |
|
|
|
535 |
|
Deferred revenue, current
portion |
|
|
401 |
|
|
|
438 |
|
Deferred rent, current portion |
|
|
35 |
|
|
|
19 |
|
Redeemable convertible notes |
|
|
29,667 |
|
|
|
33,743 |
|
Derivative liability |
|
|
28 |
|
|
|
1,156 |
|
Total current liabilities |
|
|
31,994 |
|
|
|
37,756 |
|
Deferred revenue,
noncurrent portion |
|
|
— |
|
|
|
292 |
|
Deferred rent, noncurrent
portion |
|
|
18 |
|
|
|
48 |
|
Total liabilities |
|
|
32,012 |
|
|
|
38,096 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value,
5,000,000 shares and 0 shares authorized and outstanding at
September 30, 2016 and December 31, 2015 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value,
100,000,000 shares authorized at September 30, 2016 and
December 31, 2015; 11,935,981 and 11,430,085 shares issued
and outstanding at September 30, 2016 and December 31,
2015 |
|
|
12 |
|
|
|
11 |
|
Additional paid-in capital |
|
|
163,820 |
|
|
|
162,450 |
|
Accumulated other comprehensive
income |
|
|
4 |
|
|
|
1 |
|
Accumulated deficit |
|
|
(144,232 |
) |
|
|
(131,037 |
) |
Total stockholders’ equity |
|
|
19,604 |
|
|
|
31,425 |
|
Total liabilities
and stockholders’ equity |
|
$ |
51,616 |
|
|
$ |
69,521 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Contract revenue |
|
$ |
109 |
|
|
$ |
109 |
|
|
$ |
328 |
|
|
$ |
1,641 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,396 |
|
|
|
1,486 |
|
|
|
8,443 |
|
|
|
4,192 |
|
General and administrative |
|
|
2,425 |
|
|
|
2,508 |
|
|
|
7,083 |
|
|
|
6,567 |
|
Total operating expenses |
|
|
5,821 |
|
|
|
3,994 |
|
|
|
15,526 |
|
|
|
10,759 |
|
Loss from operations |
|
|
(5,712 |
) |
|
|
(3,885 |
) |
|
|
(15,198 |
) |
|
|
(9,118 |
) |
Interest and other income,
net |
|
|
941 |
|
|
|
273 |
|
|
|
2,003 |
|
|
|
964 |
|
Interest Expense |
|
|
— |
|
|
|
(1,439 |
) |
|
|
— |
|
|
|
(1,478 |
) |
Net loss |
|
$ |
(4,771 |
) |
|
$ |
(5,051 |
) |
|
$ |
(13,195 |
) |
|
$ |
(9,632 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.93 |
) |
|
$ |
(1.14 |
) |
|
$ |
(4.65 |
) |
Shares used to compute net
loss per common share, basic and diluted |
|
|
11,846,947 |
|
|
|
5,410,864 |
|
|
|
11,575,701 |
|
|
|
2,071,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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