Catalyst Biosciences Reports Fourth Quarter and Full-Year 2019 Operating & Financial Results and Provides a Corporate Update...
February 20 2020 - 4:05PM
Catalyst Biosciences, Inc. (NASDAQ: CBIO), today announced its
operating and financial results for the fourth quarter and
full-year ending December 31, 2019 and provided a corporate update.
“We made exceptional progress in both our
subcutaneously-dosed (SQ) MarzAA (FVIIa) and SQ DalcA (FIX)
programs this past year. Earlier this month at EAHAD, positive data
was presented in an oral presentation from the Company’s Phase 2b
SQ DalcA trial in subjects with hemophilia B clearly demonstrating
efficacy and safety. We also presented data from MarzAA and Factor
IX gene therapy programs in three posters,” said Nassim Usman,
Ph.D., president and chief executive officer of Catalyst.
“Catalyst’s therapies have demonstrated the potential to
effectively treat hemophilia subcutaneously in a $3.4 billion
market.”
Dr. Usman continued, "Additionally, our February
2020 financing combined with our current cash provides funding
through several major milestones for our lead Phase 3 ready MarzAA
and Phase 2b DalcA product candidates, as well as our FIX gene
therapy and complement inhibitor programs."
Recent Milestones:
- Announced a global license and collaboration agreement with
Biogen Inc. to develop and commercialize pegylated CB 2782 and
other anti-C3 proteases for the potential treatment of dry
age-related macular degeneration (dAMD) and other disorders. Under
terms of the agreement, Biogen is solely responsible for funding
the pre-clinical and manufacturing activities and performing
IND-enabling activities, worldwide clinical development, and
commercialization. Catalyst received a $15 million upfront payment
for the transfer of an exclusive license and the related know-how;
and is eligible to receive up to $340 million in clinical,
regulatory and commercial milestone payments plus future tiered
royalties based on net sales.
- Appointed Sharon Tetlow and Geoffrey Shiu Fei Ling, M.D., to
its Board of Directors.
- Marzeptacog alfa (activated) – MarzAA, subcutaneously
administered next-generation engineered coagulation Factor VIIa:
Presented two posters at the annual ASH meeting in December 2019,
highlighting MarzAA’s broad potential as a safe and effective
therapy in hemophilia. The Company also presented two MarzAA
posters at the EAHAD Congress in February 2020. In the first
poster, Dr. Linda Neuman, vice president, clinical development,
presented data from a Phase 1 study to evaluate the
pharmacokinetics, pharmacodynamics and safety of ascending doses of
SQ MarzAA in adult subjects with hemophilia, which showed that SQ
dosing reaches target levels consistent with treatment of a bleed.
The second poster, presented by Dr. Grant Blouse, senior vice
president, translational research, showed data on SQ MarzAA
demonstrating that on-demand treatment in Hemophilia A mice treated
after a tail clip injury was as efficient as intravenous NovoSeven
at reducing bleeding.
- Dalcinonacog alfa – DalcA, subcutaneously administered
next-generation engineered coagulation Factor IX: Presented
positive data from the company’s phase 2b trial of subcutaneous
DalcA at EAHAD. Data from the trial showed that 28 days of daily SQ
dosing of DalcA achieved protective target FIX levels of >12%
with steady sate FIX levels of up to 27% after 14 days with no
bleeds and no anti-drug antibodies (ADAs) detected, demonstrating
effective prophylaxis and the potential for lower or less frequent
dosing. The data were presented in an oral presentation given by
Johnny Mahlangu, MB.B.Ch., M.Med, F.C. Path, professor of
haematology, faculty of health sciences, head of the School of
Pathology at the University of Witwatersrand in Johannesburg, South
Africa, and principal investigator in the clinical trial. Dr.
Blouse presented a poster on Hemophilia B gene therapy in mice
demonstrating that a novel chimeric AAV capsid combined with the
Company’s proprietary potency enhanced CB 2679d-GT FIX variant may
reduce the vector dose required in gene therapy while maintaining
high FIX levels.
- Raised $34.5 million in gross proceeds, before deducting
underwriting discounts and offering expenses, in an offering
of 5,307,692 shares of common stock in February
2020.
Expected Milestones
- MarzAA: Initiate a Phase 3 trial in the
second half of 2020 following the end of Phase 2 meeting with the
FDA and report final data in the second quarter of 2020 from a
MarzAA Phase 1 pharmacokinetic and pharmacodynamic study to support
future SQ treatment of bleed studies.
- DalcA: Report final Phase 2b trial data
in the second quarter of 2020.
- Factor IX Gene Therapy (CB 2679d-GT):
Present primate data in the second quarter of
2020.
- Complement Inhibitor: Continue
developing Catalyst’s wholly-owned SQ systemic complement inhibitor
program.
Fourth Quarter and Full-year 2019
Results and Financial Highlights
- Cash, cash equivalents and short-term investments, as of
December 31, 2019 were $76.9 million. This does not include the
$15M upfront payment from the Biogen CB 2782-PEG
collaboration.
- Research and development expense for the three-months and
full-year ended December 31, 2019 was $10.8 million and $43.9
million, respectively, compared with $8.2 million and $21.5 million
for the prior year periods, respectively. The increase was due
primarily to furthering development of Catalyst’s programs and
compounds.
- General and administrative expense for the three-months and
year-ended December 31, 2019 was $3.2 million and $13.4 million,
respectively, compared with $3.4 million and $12.4 million for the
prior year periods, respectively.
- Interest and other income for the three-months and year-ended
ended December 31, 2019 was $0.4 million and $2.1 million,
respectively, compared with $0.8 million and $3.8 million for the
prior year periods, respectively. Interest income was higher in
2018 due to the higher cash balances from the 2018 financing and
warrant exercises.
- Net loss attributable to common stockholders for the
three-months and year-ended December 31, 2019 was $13.6 million, or
($1.23) per basic and diluted share, and $55.2 million, or ($4.60)
per basic and diluted share, respectively, compared with $10.8
million, or ($0.97) per basic and diluted share, and $30.1 million,
or ($2.68) per basic and diluted share, for the prior year periods,
respectively.
- As of December 31, 2019, the Company had 12,040,835 shares of
common stock outstanding.
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical
company focused on addressing unmet needs in rare diseases and
systemic complement mediated disorders. Our protease engineering
platform includes development programs in hemophilia and a research
program on subcutaneous (SQ) systemic complement inhibitors. Our
engineered coagulation factors are designed to overcome the
significant limitations of current IV treatment options, facilitate
prophylaxis, and ultimately deliver substantially better outcomes
for patients using SQ dosing. Our lead asset, MarzAA has completed
Phase 2 development having met its primary endpoint of
significantly reducing the annualized bleed rate (ABR) in
individuals with hemophilia A or B with inhibitors. Our second
hemophilia asset, DalcA is completing a Phase 2b clinical trial and
is being developed for the treatment of hemophilia B. We also have
a global license and collaboration agreement with Biogen for the
development and commercialization of pegylated CB 2782 for the
potential treatment of geographic atrophy associated dry
age-related macular degeneration.
For more information, please visit
www.catalystbiosciences.com.
Forward-Looking Statements
This press release contains forward-looking
statements that involve substantial risks and uncertainties.
Forward-looking statements include statements about the potential
uses and benefits of MarzAA and DalcA to effectively and
therapeutically treat hemophilia subcutaneously, the potential
market opportunity for MarzAA and DalcA, plans to start a Phase 3
trial of MarzAA in second half of 2020 and report final data in the
second quarter of 2020 from a MarzAA Phase 1 pharmacokinetic and
pharmacodynamic study to support future SQ treatment of bleed
studies, to announce final Phase 2b trial data for DalcA in the
second quarter of 2020, plans to announce primate data for Factor
IX gene therapy in the second quarter of 2020, and potential future
milestone and royalty payments from Biogen. 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, including, but not limited to, the
risk that trials and studies may be delayed and may not have
satisfactory outcomes, that additional human trials will not
replicate the results from earlier trials, that potential adverse
effects may arise from the testing or use of DalcA, or MarzAA,
including the generation of antibodies, which has been observed in
patients previously treated with DalcA, the risk that costs
required to develop or manufacture the Company’s products will be
higher than anticipated, the risk that Biogen will terminate our
agreement with them, competition and other risks described in the
“Risk Factors” section of the Company’s quarterly report filed with
the Securities and Exchange Commission on November 7, 2019, and in
other filings with the Securities and Exchange Commission. The
Company does not assume any obligation to update any
forward-looking statements, except as required by law.
Contact:
Ana Kapor Catalyst Biosciences, Inc.
investors@catbio.com
Catalyst Biosciences,
Inc.Consolidated Balance Sheets(In
thousands, except shares and per share amounts)
|
December 31, 2019 |
|
|
December 31, 2018 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
15,369 |
|
|
$ |
31,213 |
|
Short-term investments |
|
61,496 |
|
|
|
88,914 |
|
Restricted cash |
|
— |
|
|
|
50 |
|
Accounts receivable |
|
15,000 |
|
|
|
— |
|
Prepaid and other current assets |
|
4,201 |
|
|
|
3,814 |
|
Total current assets |
|
96,066 |
|
|
|
123,991 |
|
Other assets, noncurrent |
|
257 |
|
|
|
543 |
|
Right-of-use assets |
|
1,927 |
|
|
|
— |
|
Property and equipment, net of
$0.4 million and $0.3 million of accumulated depreciation in 2019
and 2018, respectively |
|
304 |
|
|
|
386 |
|
Total
assets |
$ |
98,554 |
|
|
$ |
124,920 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
4,279 |
|
|
$ |
1,248 |
|
Accrued compensation |
|
2,106 |
|
|
|
1,495 |
|
Deferred revenue |
|
15,000 |
|
|
|
— |
|
Other accrued liabilities |
|
7,031 |
|
|
|
2,043 |
|
Operating lease liability |
|
483 |
|
|
|
— |
|
Deferred rent, current portion |
|
— |
|
|
|
15 |
|
Total current liabilities |
|
28,899 |
|
|
|
4,801 |
|
Operating lease liability,
noncurrent |
|
1,319 |
|
|
|
— |
|
Deferred rent, noncurrent
portion |
|
— |
|
|
|
174 |
|
Total liabilities |
|
30,218 |
|
|
|
4,975 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock, $0.001 par value, 5,000,000 shares authorized;
zero shares issued and outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value, 100,000,000 shares authorized;
12,040,835 and 11,954,528 shares issued and outstanding at December
31, 2019 and 2018, respectively |
|
12 |
|
|
|
12 |
|
Additional paid-in capital |
|
326,810 |
|
|
|
323,279 |
|
Accumulated other comprehensive income (loss) |
|
34 |
|
|
|
(4 |
) |
Accumulated deficit |
|
(258,520 |
) |
|
|
(203,342 |
) |
Total stockholders’ equity |
|
68,336 |
|
|
|
119,945 |
|
Total liabilities and
stockholders’ equity |
$ |
98,554 |
|
|
$ |
124,920 |
|
|
|
|
|
|
|
|
|
Catalyst Biosciences,
Inc.Consolidated Statements of
Operations(In thousands, except share and per share
amounts)
|
Year Ended December 31, |
|
|
2019 |
|
|
2018 |
|
Contract revenue |
$ |
— |
|
|
$ |
6 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
43,859 |
|
|
|
21,474 |
|
General and administrative |
|
13,418 |
|
|
|
12,354 |
|
Total operating expenses |
|
57,277 |
|
|
|
33,828 |
|
Loss from operations |
|
(57,277 |
) |
|
|
(33,822 |
) |
Interest and other income,
net |
|
2,099 |
|
|
|
3,767 |
|
Net loss |
$ |
(55,178 |
) |
|
$ |
(30,055 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(4.60 |
) |
|
$ |
(2.68 |
) |
Shares used to compute net loss
per share attributable to common stockholders, basic and
diluted |
|
12,004,489 |
|
|
|
11,213,884 |
|
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