--Completed Initial Public Offering with Gross Proceeds of $69.0
Million--
--Initiated MoveDMD study of CAT-1004 in Duchenne Muscular Dystrophy--
--Reported Positive Top-line Phase 1 Trial Data for CAT-2054 for
Hypercholesterolemia--
Catabasis
Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage drug
development company built on a pathway pharmacology technology platform,
today announced financial results for the second quarter ended June 30,
2015 and corporate highlights.
“Catabasis made notable progress in our clinical-stage programs for the
treatment of Duchenne muscular dystrophy (DMD) and hypercholesterolemia
during the second quarter of 2015,” commented Jill C. Milne, Ph.D.,
chief executive officer of Catabasis. “We initiated the MoveDMD trial of
CAT-1004, which we believe has the potential to be a disease-modifying
therapy that promotes muscle regeneration in patients with DMD,
regardless of the underlying mutation. Additionally, today we announced
positive top-line data from our Phase 1 trial of CAT-2054 for
hypercholesterolemia, and based on these data, we intend to initiate a
Phase 2a trial in patients with hypercholesterolemia in the fourth
quarter of 2015.”
“On the corporate side, we completed our IPO in June, which we believe
will provide the financial resources to complete clinical
proof-of-concept Phase 2 trials for both CAT-1004 and CAT-2054.”
Recent Corporate Highlights
-
Completed an IPO on the NASDAQ Global Market, raising gross proceeds
of $69.0 million
-
Initiated MoveDMD, a Phase 1 / 2 trial of CAT-1004, an oral
small-molecule inhibitor of activated NF-kB for the treatment of
patients with DMD
-
Received Fast Track Designation from the FDA for CAT-1004 for the
treatment of DMD
-
Announced positive top-line Phase 1 data for CAT-2054, the Company’s
product candidate targeting the Sterol Regulatory Element-Binding
Protein (SREBP) pathway for the potential treatment of
hypercholesterolemia
Second Quarter 2015 Financial Results
At June 30, 2015, Catabasis had cash and cash equivalents of $81.6
million. This includes net proceeds of $62.8 million from the Company’s
IPO in June 2015, in which Catabasis sold an aggregate of 5,750,000
shares of common stock, including 750,000 shares of common stock sold
pursuant to the underwriters’ exercise of their option to purchase
additional shares of common stock.
Net cash used in operating activities for the three months ended June
30, 2015, was $6.0 million, compared to $5.2 million for the three
months ended June 30, 2014, and $13.2 million for the six months ended
June 30, 2015, compared to $9.8 million for the six months ended June
30, 2014.
Research and development expenses were $5.9 million for the three months
ended June 30, 2015, compared to $3.7 million for the three months ended
June 30, 2014, and $10.5 million for the six months ended June 30, 2015,
compared to $6.8 million for the six months ended June 30, 2014.
General and administrative expenses were $1.8 million for the three
months ended June 30, 2015, compared to $1.6 million for the three
months ended June 30, 2014, and $3.6 million for the six months ended
June 30, 2015, compared to $3.0 million for the six months ended June
30, 2014.
Loss from operations was $7.8 million for the three months ended June
30, 2015, compared to $5.4 million for the three months ended June 30,
2014, and $14.1 million for the six months ended June 30, 2015, compared
to $9.8 million for the six months ended June 30, 2014.
Net loss was $8.0 million for the three months ended June 30, 2015,
compared to a net loss of $5.4 million for the three months ended June
30, 2014, and $14.5 million for the six months ended June 30, 2015,
compared to $9.8 million for the six months ended June 30, 2014.
About CAT-1004
CAT-1004 is an oral small molecule that inhibits activated NF-kB, a
protein that coordinates cellular response to muscular damage, stress
and inflammation and plays an important role in muscle health. In
skeletal muscle, activated NF-kB drives muscle degeneration and
suppresses muscle regeneration. In animal models of DMD, CAT-1004
inhibited activated NF-kB, reduced muscle inflammation and degeneration
and increased muscle regeneration. In Phase 1 clinical trials, CAT-1004
inhibited activated NF-kB and was well-tolerated with no observed safety
concerns. The FDA has granted CAT-1004 orphan drug and fast track
designations for the treatment of DMD. We currently are conducting the
MoveDMD Phase 1 / 2 trial of CAT-1004 in 4-7 year-old boys with DMD.
About CAT-2054
CAT-2054 is an investigational oral drug initially being developed for
the treatment of hypercholesterolemia in patients for whom existing
therapies are insufficient. By modulating the SREBP pathway, CAT-2054
may inhibit production of important cholesterol metabolism proteins such
as PCSK9, HMG-CoA reductase, ATP citrate lyase and NPC1L1. If approved,
CAT-2054, may have the potential to be the first therapy to
simultaneously modulate cholesterol synthesis, clearance and absorption.
About Catabasis
Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of novel
therapeutics using its proprietary Safely Metabolized And Rationally
Targeted, or SMART, linker technology platform. The Company's SMART
linker technology platform is based on the concept of treating diseases
by simultaneously modulating multiple targets in one or more related
disease pathways. The Company engineers bi-functional product candidates
that are conjugates of two molecules, or bioactives, each with known
pharmacological activity, joined by one of its proprietary SMART
linkers. The SMART linker conjugates are designed for enhanced efficacy
and improved safety and tolerability. The Company’s focus is on
treatments for rare diseases. The Company is also developing other
product candidates for the treatment of serious lipid disorders. For
more information on the Company's technology and pipeline of drug
candidates, 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, cash resources 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; availability and timing of results from preclinical
studies and clinical trials; 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 Quarterly
Report on Form 10-Q for the three months ended June 30, 2015, 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.
|
Condensed Balance Sheets
|
(in thousands)
|
(Unaudited)
|
|
|
|
|
June 30,
|
|
|
|
December 31,
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
81,548
|
|
|
|
|
$
|
14,668
|
|
Working capital (1)
|
|
|
|
|
74,681
|
|
|
|
|
|
10,788
|
|
Total assets
|
|
|
|
|
82,454
|
|
|
|
|
|
15,964
|
|
|
|
|
|
|
|
|
|
|
Note payable (current)
|
|
|
|
|
2,346
|
|
|
|
|
|
309
|
|
Note payable (long-term)
|
|
|
|
|
7,352
|
|
|
|
|
|
4,439
|
|
Convertible preferred stock
|
|
|
|
|
-
|
|
|
|
|
|
80,146
|
|
Stockholders' equity (deficit)
|
|
|
|
|
67,588
|
|
|
|
|
|
(73,053
|
)
|
|
|
|
|
|
|
|
|
|
(1) We define working capital as current assets minus current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Catabasis Pharmaceuticals, Inc.
|
a
|
(in thousands)
|
(Unaudited)
|
|
|
|
|
Six Months
|
|
|
|
Six Months
|
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
|
June 30, 2015
|
|
|
|
June 30, 2014
|
Cash provided by (used in)
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
$
|
(13,223
|
)
|
|
|
|
$
|
(9,763
|
)
|
Investing activities
|
|
|
|
|
(35
|
)
|
|
|
|
|
(157
|
)
|
Financing activities
|
|
|
|
|
80,138
|
|
|
|
|
|
22
|
|
Increase (decrease) in cash
|
|
|
|
|
66,880
|
|
|
|
|
|
(9,898
|
)
|
|
The accompanying notes are an integral part of these condensed
financial statements.
|
Catabasis Pharmaceuticals, Inc.
|
Condensed Statements of Operations and Comprehensive Loss
|
(in thousands, except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$
|
5,931
|
|
|
|
$
|
3,722
|
|
|
|
$
|
10,547
|
|
|
|
$
|
6,818
|
|
General and administrative
|
|
|
|
|
1,833
|
|
|
|
|
1,642
|
|
|
|
|
3,578
|
|
|
|
|
3,016
|
|
Total operating expenses
|
|
|
|
|
7,764
|
|
|
|
|
5,364
|
|
|
|
|
14,125
|
|
|
|
|
9,834
|
|
Loss from operations
|
|
|
|
|
(7,764
|
)
|
|
|
|
(5,364
|
)
|
|
|
|
(14,125
|
)
|
|
|
|
(9,834
|
)
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net
|
|
|
|
|
4
|
|
|
|
|
1
|
|
|
|
|
13
|
|
|
|
|
1
|
|
Interest expense
|
|
|
|
|
(279
|
)
|
|
|
|
-
|
|
|
|
|
(428
|
)
|
|
|
|
-
|
|
Total other (expense) income
|
|
|
|
|
(275
|
)
|
|
|
|
1
|
|
|
|
|
(415
|
)
|
|
|
|
1
|
|
Net loss and comprehensive loss
|
|
|
|
$
|
(8,039
|
)
|
|
|
$
|
(5,363
|
)
|
|
|
$
|
(14,540
|
)
|
|
|
$
|
(9,833
|
)
|
Net loss per share - basic and diluted
|
|
|
|
$
|
(8.07
|
)
|
|
|
$
|
(13.42
|
)
|
|
|
$
|
(19.46
|
)
|
|
|
$
|
(24.72
|
)
|
Weighted-average common shares outstanding used in net loss per
share - basic and diluted
|
|
|
|
|
996,592
|
|
|
(1
|
)
|
|
399,766
|
|
|
|
|
747,117
|
|
|
(1
|
)
|
|
397,782
|
|
(1) The calculation of weighted average common shares outstanding for
the three and six months ended June 30, 2015 includes the effect of
5,750,000 common shares issued in the IPO for the only the final six
days of each period, and the effect of the conversion of outstanding
preferred shares into 9,029,549 common shares upon the close of the IPO
for only the final one day of each period. As of June 30, 2015,
15,297,794 common shares were outstanding.
The accompanying notes are an integral part of these condensed
financial statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150813006326/en/
Copyright Business Wire 2015