Catalyst Biosciences Announces Change in Corporate Strategy
November 12 2021 - 7:00AM
Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced a
strategic decision to halt the clinical development of MarzAA,
report data to date, and seek a buyer for its hemophilia assets.
Catalyst plans to focus its resources on its complement
therapeutics and protease medicines platform. The Company also
reported its operating and financial results for the third quarter
ended September 30, 2021.
"We have made a strategic decision to stop the clinical
development of MarzAA (engineered FVIIa) and focus solely on our
complement programs and protease medicines platform. Based on
several factors including a recently updated feasibility
assessment, we determined that we cannot continue to develop MarzAA
through completion of the ongoing trials. Enrollment in our MarzAA
clinical trials has been adversely impacted by several factors,
including pandemic-related logistical challenges, competition for
subjects, and increasing availability of prophylaxis therapy
globally. Given these factors, it is no longer feasible for us to
deliver topline data in 2022. We will report on the data obtained
in the Crimson-1 trial to date showing that we have successfully
treated bleeds with subcutaneous (SQ) MarzAA and have not observed
any treatment-related adverse or thrombotic events,” said Nassim
Usman, Ph.D., chief executive of Catalyst Biosciences.
Dr. Usman continued: “We are exploring opportunities to license
or sell our MarzAA and DalcA (engineered FIX) portfolios and will
donate any standard-of-care to the centers where patients are
enrolled. Halting development of MarzAA will allow us to reduce our
burn rate by approximately 40% and focus our investment on our
highly promising complement therapeutics and protease medicines
platform. We want to thank our study subjects, clinical trial
investigators and site staff, employees, and investors for their
partnership and commitment to the MarzAA programs over the last
several years.”
“Candidates from our protease platform offer a differentiated
approach to complement regulation by rapidly engaging and degrading
high abundancy targets in a way antibodies and small molecule
inhibitors cannot. We believe that investing in novel solutions for
complement-mediated disease will open opportunities in multiple
settings ranging from ultra-orphan to large markets with
significant unmet needs, including nephrology, inflammation and
ophthalmology. We will advance the clinical development of CB 4332,
an SQ-dosed enhanced complement Factor I (CFI), as swiftly as
possible and continue to generate development candidates from our
protease platform that we will either license out or develop on our
own. We believe that the complement therapeutics market holds
tremendous potential and that investing our resources in these
programs is the optimal strategy going forward," concluded Dr.
Usman.
Complement Program Updates
- Presented positive preclinical data on CB 4332 at the
International Conference on Complement Therapeutics (ICCT) in
September 2021, indicating that CB 4332 has the potential to be an
effective, longer-acting SQ therapy in CFI-deficient patients by
replacing the underlying, deficient protease.
- Presented preclinical data on the ProTUNE™ platform at
the International Conference on Complement Therapeutics (ICCT
in September and the 5th Annual Complement-Based Drug Development
Summit 2021 in October, demonstrating the potential for the
platform to generate molecules for use in multiple
complement-related indications and support advancing Catalyst’s
lead molecules towards a development candidate nomination in the
Company’s first targeted indication.
- Enrolled the first two CFI deficient subjects in the ConFIdence
study, Catalyst’s global natural history study designed to assess
the clinical outcomes of patients with CFI deficiency and support
the CB 4332 development program.
Expected Milestones
- Submit an IND for CB 4332.
- Announce a development candidate from Catalyst’s ProTUNE™
platform that leverages the Company’s knowledge of CFI.
- Complete transfer of CBIO supported activities to Biogen for CB
2782-PEG, the C3 degrader for the potential treatment of dry
AMD.
Third Quarter 2021 Results and Financial
Highlights:
- Cash, cash equivalents and, investments, as of September 30,
2021 were $64.5 million.
- Research and development expenses were $20.4 million and $12.2
million during the three months ended September 30, 2021 and 2020,
respectively, an increase of approximately $8.1 million, or 66%.
The increase was due primarily to an increase of $5.1 million in
clinical manufacturing costs and an increase of $3.5 million in
preclinical research costs, partially offset by a decrease of $0.5
million in personnel and facilities costs.
- General and administrative expenses were $4.9 million and $3.8
million during the three months ended September 30, 2021 and 2020,
respectively, an increase of approximately $1.0 million, or 27%.
This increase was due primarily to an increase of $0.6 million in
professional services and $0.4 million in personnel-related
costs.
- Interest and other income (expense), net was $0.0 million and
$0.1 million during the three months ended September 30, 2021 and
2020, respectively, a decrease of $0.1 million. The decrease was
primarily due to a decrease in interest income on investments.
- Net loss attributable to common stockholders for the three
months ended September 30, 2021 was $25.2 million, or $(0.80) per
basic and diluted share, compared with $16.0 million, or $(0.73)
per basic and diluted share, for the prior year period.
- As of September 30, 2021, the Company had 31,392,618 shares of
common stock outstanding.
Conference call Company management will host a
call today, Friday, November 12, 2021 at 8:30 am Eastern Time to
discuss the changes to the corporate strategy and answer questions.
Shareholders and other interested parties may participate in the
conference call by dialing 877-425-9470 (in the U.S.) or
201-389-0878 (International) and entering passcode 13725012. The
call also will be webcast live on the Events and Presentations page
of Company's website.
About Catalyst Biosciences, the Protease Medicines
companyCatalyst is a research and clinical development
biopharmaceutical company focused on developing protease
therapeutics to address unmet medical needs in disorders of the
complement system. Proteases are natural regulators of this
biological system. We engineer proteases to create improved or
novel molecules to treat diseases that result from dysregulation of
the complement cascade. Our complement pipeline consists of a
preclinical C3-degrader program licensed to Biogen for dry
age-related macular degeneration (dAMD), an improved Complement
Factor I protease CB 4332 for SQ replacement therapy in patients
with Complement Factor I (CFI) deficiency and proteases from our
ProTUNE™ C3b/C4b degrader and ImmunoTUNE™ C3a/C5a degrader
platforms designed to target specific disorders of the complement
or inflammatory pathways.
Forward-Looking StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties. Forward-looking statements include, without
limitation, those regarding swiftly moving forward with clinical
development of CB 4332, the continued generation of candidates from
the protease platform that will either be licensed or
self-developed, reduction of burn rate, the potential that
complement will open opportunities in multiple disease settings,
submitting an IND for CB 4332, announcing a development candidate
from our ProTUNE™ platform that leverages our knowledge of CFI, and
successfully completing the transfer of CBIO supported activities
to Biogen for CB 2782-PEG, as well as statements about the benefits
of our protease engineering platform. 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
clinical trials and preclinical studies may be delayed as a result
of COVID-19, competitive products, and other factors, that Biogen
could terminate our agreement for the development of CB 2782-PEG,
that the Company's complement degraders are not yet in human
clinical trials and will require additional manufacturing
validation and preclinical testing before entering human clinical
trials, that the Company may need to raise additional capital, and
other risks described in the "Risk Factors" section of the
Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission (the "SEC") on March 4, 2021, the Quarterly
Report on Form 10-Q to be filed with the SEC on November 12, 2021,
and in other filings filed from time to time with the SEC. The
Company does not assume any obligation to update any
forward-looking statements, except as required by law.
Contact:
Ana KaporCatalyst Biosciences, Inc.investors@catbio.com
Catalyst Biosciences,
Inc.Condensed Consolidated Balance
Sheets(In thousands, except share and per share
amounts)
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
59,157 |
|
|
$ |
30,360 |
|
Short-term investments |
|
|
5,371 |
|
|
|
48,994 |
|
Accounts receivable |
|
|
1,114 |
|
|
|
3,313 |
|
Prepaid and other current assets |
|
|
8,322 |
|
|
|
6,843 |
|
Total current assets |
|
|
73,964 |
|
|
|
89,510 |
|
Long-term investments |
|
|
— |
|
|
|
2,543 |
|
Other assets, noncurrent |
|
|
869 |
|
|
|
528 |
|
Right-of-use assets |
|
|
2,613 |
|
|
|
1,832 |
|
Property and equipment, net |
|
|
1,091 |
|
|
|
433 |
|
Total
assets |
|
$ |
78,537 |
|
|
$ |
94,846 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,862 |
|
|
$ |
5,931 |
|
Accrued compensation |
|
|
2,548 |
|
|
|
2,476 |
|
Deferred revenue |
|
|
853 |
|
|
|
1,983 |
|
Other accrued liabilities |
|
|
8,144 |
|
|
|
6,743 |
|
Operating lease liability |
|
|
1,844 |
|
|
|
663 |
|
Total current liabilities |
|
|
17,251 |
|
|
|
17,796 |
|
Operating lease liability,
noncurrent |
|
|
550 |
|
|
|
981 |
|
Total liabilities |
|
|
17,801 |
|
|
|
18,777 |
|
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;
31,392,618 and 22,097,820 shares issued and outstanding at
September 30, 2021 and December 31, 2020, respectively |
|
|
31 |
|
|
|
22 |
|
Additional paid-in capital |
|
|
443,069 |
|
|
|
390,803 |
|
Accumulated other comprehensive income |
|
|
1 |
|
|
|
5 |
|
Accumulated deficit |
|
|
(382,365 |
) |
|
|
(314,761 |
) |
Total stockholders' equity |
|
|
60,736 |
|
|
|
76,069 |
|
Total liabilities and
stockholders' equity |
|
$ |
78,537 |
|
|
$ |
94,846 |
|
Catalyst Biosciences,
Inc. Condensed Consolidated Statements of
Operations(In thousands, except share and per share
amounts)(Unaudited)
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months EndedSeptember 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License |
|
$ |
— |
|
|
$ |
32 |
|
|
$ |
— |
|
|
$ |
15,100 |
|
Collaboration |
|
|
2,299 |
|
|
|
861 |
|
|
|
4,898 |
|
|
|
3,817 |
|
License and collaboration
revenue |
|
|
2,299 |
|
|
|
893 |
|
|
|
4,898 |
|
|
|
18,917 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of license |
|
|
— |
|
|
|
32 |
|
|
|
— |
|
|
|
3,102 |
|
Cost of collaboration |
|
|
2,307 |
|
|
|
879 |
|
|
|
4,926 |
|
|
|
4,030 |
|
Research and development |
|
|
20,352 |
|
|
|
12,249 |
|
|
|
52,754 |
|
|
|
38,419 |
|
General and administrative |
|
|
4,869 |
|
|
|
3,833 |
|
|
|
14,799 |
|
|
|
11,895 |
|
Total operating expenses |
|
|
27,528 |
|
|
|
16,993 |
|
|
|
72,479 |
|
|
|
57,446 |
|
Loss from operations |
|
|
(25,229 |
) |
|
|
(16,100 |
) |
|
|
(67,581 |
) |
|
|
(38,529 |
) |
Interest and other income
(expense), net |
|
|
(9 |
) |
|
|
67 |
|
|
|
(23 |
) |
|
|
1,195 |
|
Net loss |
|
$ |
(25,238 |
) |
|
$ |
(16,033 |
) |
|
$ |
(67,604 |
) |
|
$ |
(37,334 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.80 |
) |
|
$ |
(0.73 |
) |
|
$ |
(2.23 |
) |
|
$ |
(2.05 |
) |
Shares used to compute net loss
per share attributable to common stockholders, basic and
diluted |
|
|
31,379,755 |
|
|
|
22,072,243 |
|
|
|
30,382,231 |
|
|
|
18,199,575 |
|
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