Catalyst Biosciences Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
March 08 2017 - 8:01AM
- 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 Second 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 fourth quarter and full year ended December 31, 2016, and
provided an update on its hemostasis programs that include
marzeptacog alfa (activated), a next-generation Factor VIIa, and CB
2679d/ISU304, a next-generation coagulation Factor IX.
“2016 was a very productive year – we continued to advance the
development of our two highly potent next-generation coagulation
factors in development. We presented positive results for
both product candidates in subcutaneous non-clinical PK/PD studies
at medical conferences, completed the marzeptacog alfa (activated)
manufacturing technology transfer from Pfizer to CMC Biologicals,
and successfully manufactured a commercial scale engineering batch
of marzeptacog alfa (activated),” said Nassim Usman, Ph.D.,
Catalyst’s President and Chief Executive Officer. “Having laid the
groundwork in 2016 to initiate clinical trials of our Factor VIIa
and IX candidates, we are looking forward to developing therapies
with a simpler dosing method and improved long-term clinical
outcomes for individuals with hemophilia.”
Recent Highlights
- Presented positive preclinical results at the American Society
of Hematology (ASH) 2016 and the European Association of Hemophilia
and Allied Diseases (EAHAD) 2017 meetings in well-validated models
of hemophilia A and B with marzeptacog alfa (activated) and CB
2679d/ISU304:- The pharmacodynamics and pharmacokinetic
profiles of both coagulation factors demonstrated attractive
subcutaneous dosing profiles based on bioavailability, potency,
time to maximal concentration and half-life- Both candidates
have the potential to be dosed by subcutaneous injection sufficient
to correct coagulation abnormalities in individuals with
hemophilia- CB 2679d/ISU304 could potentially achieve stable
normal Factor IX activity levels
- Secured all license rights to the manufacturing materials and
processes that apply to marzeptacog alfa (activated) from Wyeth
LLC, a wholly-owned subsidiary of Pfizer
- Demonstrated the ability to manufacture marzeptacog alfa
(activated) at commercial scale with our Drug Substance CMO
partner, CMC Biologics
- Signed a drug product fill-finish manufacturing services
agreement with Symbiosis Pharmaceutical Services Limited for
marzeptacog alfa (activated) for clinical trial applications
Anticipated Milestones
- CB 2679d/ISU304: Catalyst plans to
initiate a Phase 1/2 proof-of-concept study in individuals with
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): Catalyst plans
to initiate the Phase 2 portion of a Phase 2/3 efficacy study in
individuals with hemophilia A & B with an inhibitor in the
fourth quarter of 2017.
Financial Results for the Fourth Quarter and Year Ended
December 31, 2016
- Contract revenue was $0.1 million for both the three months
ended December 31, 2016 and December 31, 2015. Contract revenue for
the years ended December 31, 2016 and 2015 was $0.4 million and
$1.8 million, respectively. The decrease in contract revenue was
due primarily to the termination of our collaboration agreement
with Pfizer in April 2015.
- Research and development expense for the three months ended
December 31, 2016 was $3.1 million, compared with $1.8 million for
the prior year period. The increase was due to an increase in
manufacturing expenses of $1.0 million and amortization expense of
$0.3 million. Research and development expenses for the years ended
December 31, 2016 and 2015 were $11.6 million and $6.0 million,
respectively, an increase of $5.6 million. The increase was due
primarily to an increase of $3.6 million related to manufacturing
expenses for marzeptacog alfa (activated), $1.0 million in
personnel-related costs, driven by our strategic restructuring and
an increase of $1.0 million 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
December 31, 2016 was $2.2 million, compared with $3.0 million for
the prior year period. The decrease was due primarily to a decrease
in the cost of professional services (resulting from expenses
related to the filing of the S-4 and preparations to be a public
company). General and administrative expenses for the years ended
December 31, 2016 and 2015 were $9.3 million and $9.6 million,
respectively, a decrease of $0.3 million.
- Interest and other income for the three months ended December
31, 2016 was $1.5 million, compared with ($0.5) million for the
prior year period. The increase was due primarily to the gain
related to the sale of noncore NNR assets. Interest and other
income for the years ended December 31, 2016 and 2015, were $3.5
million and $0.5 million, respectively, an increase of $3.0
million.
- Net loss for the three months ended December 31, 2016 was $3.7
million, or ($4.68) per basic and diluted share, compared to $5.1
million, or ($6.73) per basic and diluted share, for the prior year
period. Net loss for the years ended December 31, 2016 and 2015 was
$16.9 million, or ($21.75) basic and diluted share, compared to
$14.8 million, or ($49.99) per basic and diluted share, for the
prior year.
- Cash, cash equivalents and short-term investments as of
December 31, 2016 and 2015 were $17.1 million and $32.5 million,
respectively. 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.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 the
Phase 2 part of a Phase 2/3 efficacy clinical trial in the fourth
quarter of 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.Consolidated Balance Sheets(In
thousands, except shares and per share amounts) |
|
|
|
December 31,2016 |
|
|
December 31,2015 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
10,264 |
|
|
$ |
29,096 |
|
Short-term investments |
|
|
6,800 |
|
|
|
3,402 |
|
Restricted cash |
|
|
19,468 |
|
|
|
33,794 |
|
Deposits |
|
|
— |
|
|
|
133 |
|
Accounts
receivable |
|
|
31 |
|
|
|
492 |
|
Prepaid
and other current assets |
|
|
958 |
|
|
|
1,781 |
|
Total
current assets |
|
|
37,521 |
|
|
|
68,698 |
|
Restricted cash,
noncurrent |
|
|
125 |
|
|
|
125 |
|
Property and equipment,
net |
|
|
444 |
|
|
|
698 |
|
Total
assets |
|
$ |
38,090 |
|
|
$ |
69,521 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
837 |
|
|
$ |
939 |
|
Accrued
compensation |
|
|
596 |
|
|
|
926 |
|
Other
accrued liabilities |
|
|
805 |
|
|
|
535 |
|
Deferred
revenue, current portion |
|
|
283 |
|
|
|
438 |
|
Deferred
rent, current portion |
|
|
41 |
|
|
|
19 |
|
Redeemable convertible notes |
|
|
19,403 |
|
|
|
33,743 |
|
Derivative liability |
|
|
— |
|
|
|
1,156 |
|
Total
current liabilities |
|
|
21,965 |
|
|
|
37,756 |
|
Deferred revenue,
noncurrent portion |
|
|
47 |
|
|
|
292 |
|
Deferred rent,
noncurrent portion |
|
|
7 |
|
|
|
48 |
|
Total liabilities |
|
|
22,019 |
|
|
|
38,096 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares and no shares
authorized and outstanding at both December 31, 2016 and
December 31, 2015 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value, 100,000,000 shares authorized;
801,756 and 762,005 shares issued and outstanding at December
31, 2016 and December 31, 2015 |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
164,053 |
|
|
|
162,460 |
|
Accumulated other comprehensive income (loss) |
|
|
(1 |
) |
|
|
1 |
|
Accumulated deficit |
|
|
(147,982 |
) |
|
|
(131,037 |
) |
Total
stockholders’ equity |
|
|
16,071 |
|
|
|
31,425 |
|
Total
liabilities and stockholders’ equity |
|
$ |
38,090 |
|
|
$ |
69,521 |
|
Catalyst Biosciences,
Inc.Consolidated Statements of
Operations(In thousands, except shares and per share
amounts) |
|
|
|
Year Ended December 31, |
|
|
|
2016 |
|
|
2015 |
|
Contract revenue |
|
$ |
399 |
|
|
$ |
1,750 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
11,555 |
|
|
|
5,958 |
|
General
and administrative |
|
|
9,262 |
|
|
|
9,594 |
|
Total
operating expenses |
|
|
20,817 |
|
|
|
15,552 |
|
Loss from
operations |
|
|
(20,418 |
) |
|
|
(13,802 |
) |
Interest and other
income, net |
|
|
3,473 |
|
|
|
518 |
|
Interest expense |
|
|
— |
|
|
|
(1,478 |
) |
Net loss |
|
$ |
(16,945 |
) |
|
$ |
(14,762 |
) |
Net loss per common
share, basic and diluted |
|
$ |
(21.75 |
) |
|
$ |
(49.99 |
) |
Shares used to compute
net loss per common share, basic and diluted |
|
|
779,166 |
|
|
|
295,272 |
|
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
Catalyst Biosciences (NASDAQ:CBIO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Catalyst Biosciences (NASDAQ:CBIO)
Historical Stock Chart
From Sep 2023 to Sep 2024