-- Edasalonexent Global Phase 3 PolarisDMD
Trial in Duchenne Muscular Dystrophy Fully Enrolled with Top-Line
Results Expected in Q4 2020 --
-- Conference Call and Webcast Today at 8:30am
ET --
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage
biopharmaceutical company, today reported financial results for the
third quarter ended September 30, 2019 and reviewed recent business
progress.
“We have made significant clinical progress with our lead
program edasalonexent, a potential foundational therapy for the
treatment of Duchenne muscular dystrophy. We are excited that
enrollment is complete and target enrollment was exceeded for our
Phase 3 PolarisDMD trial of edasalonexent. We very much appreciate
the strong interest from physicians and the Duchenne community that
propelled trial enrollment. We look forward to reporting top-line
results in the fourth quarter of next year,” said Jill C. Milne,
Ph.D., Chief Executive Officer of Catabasis. “In preparation for
the potential commercialization of edasalonexent, we strengthened
our executive team with the addition of Andrew Komjathy as Chief
Commercial Officer.”
Recent and Upcoming Corporate Highlights
- Phase 3 PolarisDMD of edasalonexent in Duchenne muscular
dystrophy (DMD)
- Trial enrollment is complete and has exceeded the enrollment
target with 131 boys enrolled. Patients are enrolled across all 8
countries where the trial is active.
- Top-line results from the Phase 3 PolarisDMD trial are expected
in Q4 of 2020, and the trial is intended to support an application
for commercial registration of edasalonexent in 2021.
- Clinical findings supporting edasalonexent as a potential
foundational therapy for the treatment of DMD from the Phase 2
MoveDMD trial and open-label extension were presented at the 24th
International Annual Congress of the World Muscle Society by Dr.
Richard Finkel, M.D., Chief, Division of Neurology, Department of
Pediatrics at Nemours Children’s Health System, and Principal
Investigator for the MoveDMD and Phase 3 PolarisDMD trials of
edasalonexent in DMD. Edasalonexent slowed disease progression
compared to the off-treatment control period and was well tolerated
through 60 cumulative years of patient exposure in boys affected by
DMD.
- Catabasis named Andrew A. Komjathy as its Chief Commercial
Officer, adding deep rare disease commercial experience to the
executive team.
- Catabasis and the Jain Foundation announced a preclinical
research collaboration to study edasalonexent in Dysferlinopathy,
which includes Limb-girdle muscular dystrophy type 2B and Miyoshi
myopathy. Edasalonexent has the potential to benefit patients with
other diseases beyond DMD, such as Dysferlinopathy.
Third Quarter 2019 Financial Results
Cash Position: As of September 30, 2019, Catabasis had
cash, cash equivalents and short-term investments of $40.6 million,
compared to $46.1 million as of June 30, 2019. Based on the
Company’s current operating plan, Catabasis expects that it has
sufficient cash to fund operations beyond top-line Phase 3 results
and through 2020. Net cash used in operating activities for the
three months ended September 30, 2019 was $6.5 million, compared to
$5.8 million for the three months ended September 30, 2018.
R&D Expenses: Research and development expenses were
$4.7 million for the three months ended September 30, 2019,
compared to $3.9 million for the three months ended September 30,
2018.
G&A Expenses: General and administrative expenses
were $2.0 million for the three months ended September 30, 2019,
compared to $2.1 million for the three months ended September 30,
2018.
Operating Loss: Loss from operations was $6.7 million for
the three months ended September 30, 2019, compared to $6.0 million
for the three months ended September 30, 2018.
Net Loss: Net loss was $6.5 million, or $0.56 per share,
for the three months ended September 30, 2019, compared to a net
loss of $5.7 million, or $0.80 per share, for the three months
ended September 30, 2018.
Conference Call and Webcast Catabasis will host a
conference call and webcast at 8:30am ET today to provide an update
on corporate developments and to discuss third quarter 2019
financial results.
Participant Toll-Free Dial-In Number:
(877) 388-2733
Participant International Dial-In
Number:
(541) 797-2984
Pass Code:
4740699
Please specify to the operator that you would like to join the
“Catabasis Third Quarter 2019 Results Call.”
Interested parties may access a live audio webcast of the
conference call via the investor section of the Catabasis website,
www.catabasis.com. Please connect to the Catabasis website several
minutes prior to the start of the broadcast to ensure adequate time
for any software download that may be necessary. The webcast will
be archived for 90 days.
About Edasalonexent (CAT-1004) Edasalonexent (CAT-1004)
is an investigational oral small molecule designed to inhibit NF-kB
that is being developed as a potential foundational therapy for all
patients affected by DMD, regardless of their underlying mutation.
In DMD the loss of dystrophin leads to chronic activation of NF-kB,
which is a key driver of skeletal and cardiac muscle disease
progression. Our ongoing global Phase 3 PolarisDMD trial is
evaluating the efficacy and safety of edasalonexent for
registration purposes. Edasalonexent is also being dosed in the
open-label extension trial GalaxyDMD. In our MoveDMD Phase 2 trial
and open-label extension, we observed that edasalonexent preserved
muscle function and substantially slowed disease progression
compared to rates of change in a control period, and significantly
improved biomarkers of muscle health and inflammation. The FDA has
granted orphan drug, fast track, and rare pediatric disease
designations and the European Commission has granted orphan
medicinal product designation to edasalonexent for the treatment of
DMD. For a summary of clinical results, please visit
www.catabasis.com.
About Catabasis At Catabasis Pharmaceuticals, our mission
is to bring hope and life-changing therapies to patients and their
families. Our lead program is edasalonexent, an NF-kB inhibitor in
Phase 3 development for the treatment of Duchenne muscular
dystrophy. For more information on edasalonexent and our Phase 3
PolarisDMD trial, please visit www.catabasis.com.
Forward Looking Statements Any statements in this press
release about future expectations, plans and prospects for the
Company, including statements about future clinical trial plans
including, among other things, statements about the Company’s
global Phase 3 PolarisDMD trial in DMD to evaluate the efficacy and
safety of edasalonexent for registration purposes and the
open-label extension trial GalaxyDMD, including the anticipated
timing for top-line results, the potential timing for the filing of
an NDA, the Company's cash expectations, the Company’s planned
transition to a commercial-stage organization and other statements
containing the words “believes,” “anticipates,” “plans,” “expects,”
“may” and similar expressions, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: uncertainties inherent in the
initiation and completion of preclinical studies and clinical
trials and clinical development of the Company’s product
candidates; whether interim results from a clinical trial will be
predictive of the final results of the trial or the results of
future trials; expectations for regulatory approvals to conduct
trials or to market products; availability of funding sufficient
for the Company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements; other matters that could
affect the availability or commercial potential of the Company’s
product candidates; and general economic and market conditions and
other factors discussed in the “Risk Factors” section of the
Company’s Annual Report on Form 10-Q for the year ended September
30, 2019, which is on file with the Securities and Exchange
Commission, and in other filings that the Company may make with the
Securities and Exchange Commission in the future. In addition, the
forward-looking statements included in this press release represent
the Company’s views as of the date of this press release. The
Company anticipates that subsequent events and developments will
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this release.
Catabasis Pharmaceuticals,
Inc. Consolidated Statements of Operations (In thousands,
except share and per share data) (Unaudited)
Three Months Ended September 30, Nine Months Ended
September 30,
2019
2018
2019
2018
Operating expenses: Research and development
4,697
3,897
14,054
13,383
General and administrative
1,985
2,111
6,287
6,900
Total operating expenses
6,682
6,008
20,341
20,283
Loss from operations
(6,682)
(6,008)
(20,341)
(20,283)
Other income (expense): Interest expense
-
(10)
-
(100)
Interest and investment income
214
177
697
252
Other (expense) income, net
(46)
162
(39)
321
Total other income, net
168
329
658
473
Net loss
$
(6,514)
$
(5,679)
$
(19,683)
$
(19,810)
Net loss per share - basic and diluted
$
(0.56)
$
(0.80)
$
(1.80)
$
(4.54)
Weighted-average common shares outstanding used in net loss per
share - basic and diluted
11,624,232
7,103,842
10,945,765
4,360,395
Catabasis Pharmaceuticals,
Inc. Selected Consolidated Balance Sheets Data (In thousands)
(Unaudited)
September 30,
December 31,
2019
2018
Assets Cash and cash equivalents
$
17,765
$
15,294
Short-term investments
22,850
22,276
Right-of-use asset
965
-
Other current and long-term assets
2,254
1,599
Total assets
43,834
39,169
Liabilities and stockholders’ equity Current portion of
operating lease liabilities
929
-
Other current and long-term liabilities
4,632
4,227
Total liabilities
5,561
4,227
Total stockholders’ equity
$
38,273
$
34,942
Catabasis Pharmaceuticals,
Inc. Selected Consolidated Statements of Cash Flows Data (In
thousands) (Unaudited)
Nine Months Ended September 30,
2019
2018
Net cash used in operating activities
$
(18,799
)
$
(18,196
)
Net cash used in investing activities
(578
)
(22,999
)
Net cash provided by financing activities
21,848
44,702
Net increase in cash, cash equivalents and restricted cash
$
2,471
$
3,507
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191107005197/en/
Investor and Media Contact Andrea
Matthews Catabasis Pharmaceuticals, Inc. T: (617) 349-1971
amatthews@catabasis.com
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