SAN DIEGO, April 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS), a biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology, today reported its financial results and highlights for the first quarter ended March 31, 2008.
"We made significant progress in both of our development programs during the first quarter," said Steve Worland, Ph.D., President and CEO of Anadys. "We successfully completed preclinical evaluation of ANA598, our non-nucleoside polymerase inhibitor for the treatment of hepatitis C, and have subsequently filed an IND for this product candidate. We also commenced dosing with ANA773, our oral TLR7 agonist prodrug, in patients with advanced cancer." Providing an updated cash outlook for 2008, Dr. Worland added, "Based on promising results from the preclinical evaluation of ANA598, we have made the strategic decision to accelerate certain non-clinical development activities for ANA598 into 2008 and now expect our cash utilization this year to be in the range of $29 million to $31 million."
As of March 31, 2008, the Company's cash, cash equivalents and securities available-for-sale totaled $48.8 million compared to $56.5 million as of December 31, 2007.
During the first quarter of 2008 the Company had no revenue, compared to $1.1 million in revenue for the same quarter of 2007. The revenue in the first quarter of 2007 was primarily derived from the amortization of an upfront payment and milestone payment under a prior collaboration.
Research and development expenses were $6.0 million for the first quarter of 2008 compared to $6.7 million for the first quarter of 2007. The $0.7 million decrease primarily resulted from cost savings derived from our completed strategic restructuring and associated termination of prior development programs, partially offset by an increase in development costs for ANA773 and ANA598 in the first quarter of 2008 compared to the first quarter of 2007.
General and administrative expenses remained relatively consistent at approximately $2.1 million for the first quarter of both 2008 and 2007.
Operating expenses were $8.1 million for the first quarter of 2008, compared to $8.8 million for the first quarter of 2007. Included as a component of Anadys' operating expenses were non-cash, share-based expenses of $0.7 million and $1.1 million for the first quarter of 2008 and 2007, respectively.
The net loss was $7.4 million for the first quarter of 2008, compared
to a net loss of $6.7 million for the first quarter of 2007. Basic and
diluted net loss per common share was $0.26 in the first quarter of 2008
compared to $0.23 in the first quarter of 2007. Non-cash share-based
expense resulted in a $0.02 and $0.04 decrease in basic and diluted net
loss per share for the three months ended March 31, 2008 and 2007,
Recent Development Program Highlights
-- Completion of Preclinical Activities and IND filing for ANA598. In the
first quarter, Anadys completed preclinical activities required to
advance ANA598 into clinical studies. Subsequent to the close of the
quarter, Anadys submitted an Investigational New Drug (IND) application
to the U.S. Food and Drug Administration (FDA). Pending allowance of
the IND by the FDA, Anadys expects to commence a Phase I single,
ascending-dose clinical trial in healthy volunteers in the second
quarter of 2008 to assess the safety and pharmacokinetics of ANA598.
Following the healthy volunteer study, Anadys plans to initiate a
short-term Phase Ib study of ANA598 in patients with chronic hepatitis
C virus (HCV) infection in the third quarter of 2008.
-- Initiation of Phase I Clinical Trial for ANA773. In late February,
Anadys announced that patient dosing had commenced in a Phase I study
of ANA773, the Company's oral TLR7 agonist prodrug, in patients with
advanced solid tumors. This first-in-human trial is a safety and
tolerability study designed to identify pharmacologically active doses
and preliminary antitumor activity as well as to select the dose and
schedule for Phase II trials.
Recent Scientific Presentations
-- ANA598. Earlier this month, Anadys presented a late-breaker oral
presentation at the 21st International Conference on Antiviral Research
(ICAR) in Montreal providing updated preclinical data on ANA598. The
data presented at ICAR included preclinical attributes of the product
candidate that support the potential for beneficial combination of
ANA598 with several other anti-HCV agents. Specifically, ANA598 was
reported to be highly synergistic with interferon-alpha and
non-antagonistic with ribavirin in cell-based assays. ANA598 was also
shown to retain full activity against a number of replicon mutations
known to confer resistance to other anti-HCV agents currently in
clinical development, including protease inhibitors and nucleoside
-- ANA773. Anadys presented data on ANA773 earlier this month in two
poster sessions at the Annual Meeting of the American Association for
Cancer Research (AACR) in San Diego. One of the posters, based on work
done with the Moores Cancer Center at the University of California San
Diego, reported the pro-apoptotic effect of the active metabolite of
ANA773 on human chronic lymphocytic leukemia (CLL) cells ex vivo, and
the enhancement of the apoptotic effect when added to either
vincristine or fludarabine. The other poster reported that in vivo
immunostimulatory responses to ANA773 can be effectively modified by
varying the schedule of dose administration, including every other day
dosing (QOD), and three consecutive days of dosing within each seven
day cycle (3-on, 4-off).
Program Updates and Revised Cash Outlook for 2008
-- ANA598 Development Activities. Based on promising results from the
preclinical evaluation of ANA598, Anadys has made the strategic
decision to accelerate certain non-clinical activities for this
program, including further manufacturing of drug substance and
conducting additional toxicology studies. These studies include a
combination toxicology study with ribavirin that will support the
clinical investigation of ANA598 in combination with interferon and
ribavirin, as well as studies extending the duration of dosing beyond
the recently completed 28 day toxicology study. If ANA598 is
successful in early stage clinical trials, it is anticipated that the
acceleration of these non-clinical activities into 2008 will enable a
more rapid and continuous development path into mid-stage clinical
trials during 2009.
-- ANA773 Development Activities. Anadys continues to explore the safety
and tolerability profile of ANA773 in the ongoing Phase I trial and
expects to identify pharmacologically active doses and establish the
profile of immune stimulation this year, which information will support
the future design of clinical trials of ANA773 (alone or in
combinations) in specific tumor types. While Anadys expects the rate
of enrollment in the ANA773 oncology trial to increase in the coming
quarters, the Company now expects the pace of the program to accelerate
more slowly than had been previously anticipated, in part due to the
increased focus on the ANA598 program, making it less likely that
specific tumor types and a recommended Phase II dose will be identified
during 2008. As a result of this slower pace, the Company expects that
some spending on ANA773 that had been anticipated in 2008 will now be
postponed into 2009.
-- Revised Cash Outlook. Based primarily on the acceleration of ANA598
HCV development activities, partially offset by modestly decreased
spending in 2008 in the ANA773 oncology program, Anadys is revising its
expected net cash utilization for 2008 to be in the range of
$29 million to $31 million.
Webcast of Conference Call
Anadys will host a conference call at 5:00 p.m. EDT today to discuss its first quarter financial results and highlights and to provide an update on its development programs. A live webcast of the call will be available online at http://www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 65984063. The webcast and telephone replay will be available through May 14, 2008.
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. The Company is developing ANA598, a small-molecule, non- nucleoside inhibitor of the NS5b polymerase for the treatment of chronic hepatitis C, and ANA773, an oral TLR7 agonist prodrug for cancer.
Safe Harbor Statement
Statements in this press release that are not strictly historical in
nature constitute "forward-looking statements." Such statements include,
but are not limited to, references to the expected timing and planned
development activities for ANA598 and ANA773, including the occurrence,
timing and pace of future clinical trials, the belief that ANA598 has the
potential for beneficial combination with several other anti-HCV agents,
the anticipated future clinical benefits of ANA598 and ANA773 and
expectations regarding cash utilization. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors, which may
cause Anadys' actual results to be materially different from historical
results or from any results expressed or implied by such forward-looking
statements. For example, the results of preclinical studies may not be
predictive of future results, and Anadys cannot provide any assurances that
ANA598 or ANA773 will not have unforeseen safety issues, will have
favorable results in future clinical trials or will receive regulatory
approval. In addition, Anadys' results may be affected by competition from
other biotechnology and pharmaceutical companies, its effectiveness at
managing its financial resources, its ability to successfully develop and
market products, difficulties or delays in its preclinical studies or
clinical trials, difficulties or delays in manufacturing its clinical
trials materials, the scope and validity of patent protection for its
products, regulatory developments involving future products and its ability
to obtain additional funding to support its operations. Risk factors that
may cause actual results to differ are more fully discussed in Anadys' SEC
filings, including Anadys' Form 10-K for the year ended December 31, 2007.
All forward-looking statements are qualified in their entirety by this
cautionary statement. Anadys is providing this information as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new information,
future events or otherwise.
Condensed Consolidated Financial Statements
Anadys Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands except per share amounts)
Three Months Ended March 31,
Revenues $ -- $1,102
Research and development (1) 6,009 6,698
General and administrative 2,045 2,119
Total operating expenses (2) 8,054 8,817
Interest income and other, net 610 1,032
Net loss (2) $(7,444) $(6,683)
Net loss per share, basic and diluted (2) $(0.26) $(0.23)
Share used in calculating net loss per share,
basic and diluted 28,697 28,620
(1) Includes $46 and $275 as an offset in research and development
expense, which represents an estimate of the net reimbursement by
Novartis of ANA975 research and development costs for the three months
ended March 31, 2008 and 2007, respectively.
(2) Includes non-cash operating expenses of $661 and $1,089 determined in
accordance with Statement of Financial Accounts Standards No. 123(R),
"Share-Based Payment" (SFAS No. 123(R)) or approximately $0.02 and
$0.04 effect on basic and diluted net loss per common share for the
three months ended March 31, 2008 and 2007, respectively. Research
and development expense and general and administrative expense
includes $310 and $351 of non-cash operating expenses determined in
accordance with SFAS No. 123(R) for the three months ended March 31,
2008. Research and development expense and general and administrative
expense includes $644 and $445 of non-cash operating expenses
determined in accordance with SFAS No. 123(R) for the three months
ended March 31, 2007.
Anadys Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
March 31, December 31,
Cash, cash equivalents and securities
available-for-sale $48,799 $56,495
Other current assets 873 1,004
Noncurrent assets 3,822 4,027
Total assets $53,494 $61,526
Liabilities and Stockholders' Equity
Current liabilities $4,138 $5,415
Other long-term liabilities 271 432
Stockholders' equity 49,085 55,679
Total liabilities and stockholders' equity $53,494 $61,526
|SOURCE Anadys Pharmaceuticals, Inc.|
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