Exhibit 99.1
CONTACT: Pamela L. Dull, Sonus Pharmaceuticals, Inc.,
(425) 487-9500, Ext. 255
Sonus Pharmaceuticals Reports First Quarter
Progress and Financial Results
Quarterly conference call today at 1:30 P.M.
PDT/4:30 P.M. EDT
BOTHELL, Washington, May 9, 2005—Sonus
Pharmaceuticals, Inc. (Nasdaq:SNUS) today
highlighted progress and reported financial results for the first quarter ended
March 31, 2005.
“In the first quarter, we remained focused on the implementation of our
strategy for TOCOSOL® Paclitaxel, and we are making good
progress toward realizing our goal of performing the Phase 3 pivotal trial,”
said Michael A. Martino, President and CEO of Sonus Pharmaceuticals. “We are eager to confirm the potential
advantages of TOCOSOL Paclitaxel, and believe we are squarely on track with a
Phase 3 development program that will position our product competitively in the
attractive and growing taxane market.”
First Quarter 2005 Highlights
• Continued in
discussions with the U.S. Food and Drug Administration (FDA) to reach agreement
on the Special Protocol Assessment
(SPA) for the Phase 3 trial of TOCOSOL Paclitaxel. Based on discussions to date, the company’s
goal is to finalize the SPA by the end of the second quarter of 2005. However, Sonus cannot manage the content or
timing of FDA decisions or actions.
• Met with the FDA
in March to review the Chemistry, Manufacturing and Controls (CMC)
information that will support the New Drug Application (NDA) for TOCOSOL
Paclitaxel. The FDA agreed that the current
CMC information is sufficient to initiate Phase 3 testing and that the data
which the company intends to include in its NDA would be sufficient for FDA
review of that application.
• Continued
progress in the Phase 2b study of TOCOSOL Paclitaxel in metastatic breast
cancer. To date, the
investigator-reported response rate in this group of patients is at least 51%
after 16 weeks of treatment. At present,
data reporting is incomplete and ongoing as the study continues. However, the company plans to submit results
for presentation at the San Antonio Breast Cancer Symposium in early December,
including confirmed objective response rate, estimated median time to disease
progression, and safety data.
More
• Received notice
that the American Society of Clinical Oncology (ASCO) selected a TOCOSOL
Paclitaxel abstract for poster presentation at its annual meeting to be held in
Orlando, Florida, May 13-17. Sonus
will present data from a clinical pharmacology study of TOCOSOL Paclitaxel and
Taxol® conducted in 2004.
This study included analyses of the amounts of paclitaxel in the blood
circulation following single doses of TOCOSOL Paclitaxel and Taxol, and results
showed that TOCOSOL Paclitaxel delivered substantially more active paclitaxel
into circulation. Full results of the
study will be available at ASCO.
• Continued to
monitor the long-term value of treatment with TOCOSOL Paclitaxel in the Phase
2a trials of ovarian, non-small cell lung and bladder cancers that began in
2002 and completed patient enrollment in mid-2003. Maturing data on survival duration indicate
that, following second-line treatment with TOCOSOL Paclitaxel, median survival
in each study is estimated to be similar to published results for combination
chemotherapy regimens used in the treatment of these types of cancer.
First
Quarter Financial Results
For the first quarter of 2005, the company reported a net loss of $4.8
million, or $0.22 per share, compared with a net loss of $3.6 million, or $0.20
per share, in the first quarter of 2004.
The planned higher net loss primarily reflected increased R&D
spending to support additional clinical studies for TOCOSOL Paclitaxel as well
as higher G&A costs related to business development activities and the
termination of the Synt:em acquisition. Cash and marketable securities totaled $15.1
million at March 31, 2005.
Quarterly
Conference Call
Sonus will host its quarterly conference call today, Monday, May 9,
at 1:30 P.M. Pacific Time/4:30 P.M. Eastern Time. The call will be web cast live and archived
on the company’s web site at www.sonuspharma.com/events.html. A telephone replay of the conference call
will also be available for one week at (800) 642-1687 or (706) 645-9291
for international calls; Conference ID 5671724; Pass code 010315.
About Sonus
Pharmaceuticals, Inc.
Headquartered near Seattle,
Sonus Pharmaceuticals is focused on the development of therapeutic drugs that
may offer improved administration, safety, tolerability and effectiveness for
the treatment of cancer and related indications. The company’s lead product candidate is
TOCOSOL Paclitaxel, a novel formulation of the widely prescribed anti-cancer
drug paclitaxel. TOCOSOL Paclitaxel has
been designed to overcome the limitations associated with Taxol and generic
paclitaxel-based chemotherapy, including long infusion times, undesirable or
treatment-limiting side effects as well as time consuming and expensive
preparation prior to administration. Sonus
is currently in discussions with the FDA to finalize the Special Protocol
Assessment agreement for the pivotal Phase 3 trial of TOCOSOL Paclitaxel, which
the company expects to initiate in 2005.
For additional information about Sonus, including past news releases,
please visit www.sonuspharma.com.
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Safe Harbor
Certain statements made in this press release
are forward-looking such as those, among others, relating to the development,
safety and efficacy of drug delivery products and potential applications for
these products or the anticipated date of the initiation of Phase 3 clinical
trials for TOCOSOL Paclitaxel. As
discussed in Sonus Pharmaceuticals’ filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K filed on March 23,
2005, actual results could differ materially from those projected in the
forward-looking statements as a result of the following factors, among
others: the company’s products will
require extensive clinical testing and approval by regulatory authorities; such
approvals are lengthy and expensive and may never occur; risks that the company
will not be able to initiate Phase 3 clinical trials for TOCOSOL Paclitaxel;
risks that clinical studies with TOCOSOL Paclitaxel will not be successful;
risks that the FDA may not approve the company’s proposed New Drug Application;
risks of successful development of additional drug delivery products; and risks
that the company may not be successful in obtaining funding from third parties
or completing a financing necessary to support the costs and expenses of
clinical studies as well as research and development activities. The company undertakes no obligation to
update the forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof.
###
3
Condensed Statements of Operations
(Unaudited)
(in
thousands, except per share amounts)
|
|
|
Three
Months Ended March 31,
|
|
|
|
|
2005
|
|
2004
|
|
|
|
|
$
|
—
|
|
$
|
—
|
|
|
Revenue
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
Research and development
|
|
3,123
|
|
2,568
|
|
|
General and administrative
|
|
1,743
|
|
1,046
|
|
|
Total operating expenses
|
|
4,866
|
|
3,614
|
|
|
Operating loss
|
|
(4,866
|
)
|
(3,614
|
)
|
|
Other income, net
|
|
91
|
|
36
|
|
|
Loss before taxes
|
|
(4,775
|
)
|
(3,578
|
)
|
|
Taxes
|
|
—
|
|
—
|
|
|
Net loss
|
|
$
|
(4,775
|
)
|
$
|
(3,578
|
)
|
|
Net loss per share:
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.22
|
)
|
$
|
(0.20
|
)
|
|
Diluted
|
|
$
|
(0.22
|
)
|
$
|
(0.20
|
)
|
|
|
|
|
|
|
|
|
Shares used in calculation:
|
|
|
|
|
|
|
Basic
|
|
21,354
|
|
18,046
|
|
|
Diluted
|
|
21,354
|
|
18,046
|
|
|
|
|
|
|
|
|
Condensed
Balance Sheets
(in thousands)
|
|
|
March 31,
|
|
December 31,
|
|
|
|
|
2005
|
|
2004
|
|
|
|
|
(unaudited)
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
Cash and marketable securities
|
|
$
|
15,139
|
|
$
|
20,580
|
|
|
Other current assets
|
|
284
|
|
459
|
|
|
Property and equipment, net
|
|
1,366
|
|
1,480
|
|
|
Other assets
|
|
52
|
|
52
|
|
|
Total assets
|
|
$
|
16,841
|
|
$
|
22,571
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity:
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
2,237
|
|
$
|
3,177
|
|
|
Lease obligations
|
|
80
|
|
121
|
|
|
Deferred rent
|
|
180
|
|
196
|
|
|
Stockholders’ equity
|
|
14,344
|
|
19,077
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
16,841
|
|
$
|
22,571
|
|
Taxol® is a registered
trademark of Bristol-Myers Squibb Company.
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