Investor Contact: Media
Contact:
James T.
Glover Ian
Stone or David Schull
SVP, Operations & CFO Russo
Partners, LLC
Anadys Pharmaceuticals, Inc. (619)
528-2220
(858) 530-3763 ian.stone@russopartnersllc.com
jglover@anadyspharma.com david.schull@russopartnersllc.com
ANADYS PHARMACEUTICALS REPORTS FIRST QUARTER
2009 FINANCIAL RESULTS AND HIGHLIGHTS
San Diego, April
23, 2009 – 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, 2009.
”We
have now concluded three Phase I trials of ANA598, including a study in HCV
patients that demonstrated potent antiviral activity over three days,” said
Financial Results
As
of March 31, 2009, the Company’s cash, cash equivalents and securities
available-for-sale totaled $20.8 million compared to $27.9 million as of
December 31, 2008.
Research
and development expenses were $6.9 million for the first quarter of 2009
compared to $6.0 million for the first quarter of 2008. The $0.9 million
increase primarily resulted from a $1.7 million increase in development costs
for ANA598 in the first quarter of 2009 compared to the first quarter of 2008, partially offset by a
decrease in our ANA773 development costs. The ANA598 development costs were associated with
our completed Phase Ib clinical trial which was initiated during September
2008, our 14-day healthy volunteer study which was initiated in February 2009
and our on-going long-term chronic toxicology studies which were initiated
during September 2008. Our ANA773 development costs during the three months
ended March 31, 2009 were primarily driven by our on-going Phase I clinical
trial for the treatment of HCV.
General and
administrative expenses remained relatively consistent at approximately $2.1
million for the first quarter of 2009 and $2.0 million for the first quarter of
2008.
Operating expenses
were $8.9 million for the first quarter of 2009, compared to $8.1 million for
the first quarter of 2008. Included as a
component of Anadys’ operating expenses were non-cash, share-based expenses of
$0.7 million for the first quarter of 2009 and 2008.
The
net loss was $8.8 million for the first quarter of 2009, compared to a net loss
of $7.4 million for the first quarter of 2008.
Basic and diluted net loss per common share was $0.30 in the first
quarter of 2009 compared to $0.26 in the first quarter of 2008. Non-cash share-based expense resulted in a
$0.02 increase in basic and diluted net loss per share for the three months
ended March 31, 2009 and 2008.
Development Program Highlights
ANA598
ANA598 is an investigational oral
non-nucleoside polymerase inhibitor that Anadys is developing for the treatment
of chronic hepatitis C virus (HCV) infection. Three Phase I trials, including one in HCV
patients, are now completed and the program remains on track to be ready in
mid-2009 for Phase II studies of ANA598 in combination with current
standard of care. The actual timing for
the initiation of Phase II studies may depend on a number of factors, including
FDA review timelines, the timing of any potential transaction around ANA598 or
ANA773, available cash resources and funding activities, and the engagement of
clinical sites.
·
Potent Antiviral Activity in HCV. Earlier today,
Anadys presented antiviral and safety data from all three dose levels in the recently completed Phase Ib clinical trial of ANA598
in HCV patients in a late-breaker poster entitled, “Antiviral Activity
of ANA598, a Potent Non-Nucleoside Polymerase Inhibitor, In Chronic Hepatitis C
Patients,” at the 44th Annual Meeting of the European Association for
the Study of the Liver (EASL). In the Phase Ib study, ANA598 treatment resulted in rapid
and sustained reductions in HCV RNA with median reductions at end of treatment
(Day 4) exceeding 2 log10 (>99%) at all dose levels. At 200 mg bid, the median viral load
reduction was 2.4 log10 (range of 0.4 to 3.4); at 400 mg bid, 2.3
log10 (range of 1.6 to 3.5); and at 800 mg bid, 2.9 log10
(range of 2.2 to 3.4). Genotype 1a
patients demonstrated median reductions of 1.4 log10, 1.8 log10,
and 2.5 log10 at 200, 400 and 800 mg bid, respectively. In 10 of the
12 genotype 1a patients who received ANA598, viral load was still declining at
the end of the three days of treatment.
Genotype 1b patients demonstrated median reductions of 2.6 log10,
2.5 log10 and 3.2 log10, at 200, 400 and
800 mg bid, respectively. No patient showed evidence of viral rebound while on
ANA598. ANA598 was well-tolerated in
this short term study and there were no serious adverse events.
·
14-day Healthy Volunteer Study. Anadys
recently completed dosing healthy volunteers in a 14-day study conducted to
extend the safety and pharmacokinetic profile of ANA598. Thirty subjects participated in
the study, with eight subjects receiving ANA598 and two subjects receiving
placebo at each dose level (400 mg once-daily, 800 mg once-daily and 600 mg
bid). Subjects received a single dose on
day one followed by pharmacokinetic assessment over days two and three and
received subsequent doses consecutively on days four through fourteen.
Preliminary results from the study indicate that ANA598 was generally
well-tolerated in all cohorts with no serious adverse events, although three
subjects (two subjects in the 800 mg once-daily cohort and one subject in the
600 mg bid cohort) developed grade 2 rash and discontinued treatment after
either six or seven days of consecutive dosing.
There were no other instances of rash in this or any other study of
ANA598. Data receipt and analysis from
this study is continuing, and the Company expects to present the results at a
clinical conference later this year. The
Company believes the results of this study, combined with the results of the
Phase Ib study in HCV patients, contribute
to the attractive profile of ANA598 as an antiviral likely to be active in
long-term studies in combination with pegylated interferon and ribavirin, and
help position the program to be ready for Phase II in mid-2009.
- Long-Term Chronic Toxicology Studies. In
September 2008, Anadys initiated long-term, chronic toxicology studies of
ANA598, of 26 weeks duration in rats and 39 weeks duration in monkeys. Based on a now completed analysis of
data at the 13-week interim in both species, the No Observed Adverse
Effect Level (NOAEL) in monkeys and male rats remains 1000 mg/kg at 13
weeks, the highest dose being tested in the chronic studies. In female rats the NOAEL at the 13-week
interim was 300 mg/kg, with the only adverse finding in female rats,
observed only in the 1000 mg/kg dose group, being a marginal decrease in
the rate of weight gain. Anadys
previously reported NOAELs in both species after 28 days of 1000 mg/kg,
the highest dose tested in that study.
The dosing portion of the 26-week study in rats is now complete,
while the dosing portion of the 39-week study in monkeys is scheduled to
conclude in June. Anadys expects
that the results from these chronic toxicology studies, if continuing to
be favorable, will enable dosing of ANA598 for up to 48 weeks in the Phase
II study of ANA598 in combination with pegylated interferon and ribavirin.
- Preclinical Data at EASL. On
April 24, Anadys will present additional data on the preclinical profile
of ANA598 at the EASL meeting in an oral presentation titled, “Preclinical
Studies of ANA598 Combined with Other Anti-HCV Agents Demonstrate
Potential of Combination Treatment.” Anadys will present in vitro data
showing that combinations of ANA598 with interferon-alpha, the protease
inhibitor telaprevir and the nucleoside polymerase inhibitor PSI-6130 are
synergistic. These studies also
show that ANA598 retains activity against mutants known to confer
resistance to other classes of direct antivirals, including protease
inhibitors, nucleoside inhibitors and non-nucleosides that, through virtue
of binding at a different site than ANA598, display a resistance profile
distinct from that of ANA598.
Genotypic mutations resistant to ANA598 will be shown to be fully
susceptible to interferon-alpha, telaprevir and PSI-6130.
ANA773
ANA773 is an oral prodrug
of a small molecule inducer of endogenous interferons that acts via the
toll-like receptor 7 (TLR7) pathway.
Anadys has completed 3-month toxicology and pharmacology studies in
animals that demonstrated stable induction of interferon-dependent pathways at
doses that led to no adverse findings.
Anadys is exploring ANA773 in chronic Hepatitis C and oncology.
- Phase I
Clinical Trial in HCV. Patient dosing in a Phase I clinical
trial of ANA773 in HCV has been completed through 1600 mg dosed every
other day (QOD). Based on the
encouraging data we have seen to date, Anadys has submitted an amendment
to this study to test ANA773 at 2000 mg QOD. In the completed cohorts, HCV patients received
oral ANA773 or placebo every other day over 28 days, at doses of 800 mg,
1200 mg or 1600 mg, with six subjects receiving ANA773 and two receiving
placebo in each cohort. There was a
statistically significant decrease in viral load in the group dosed at
1600 mg compared to placebo, although not all patients at this dose
demonstrated a decrease in viral load.
One patient at 1600 mg demonstrated a nadir response of 0.8 log10 decline with an
end-of-treatment response of 0.7 log10; a second patient demonstrated a nadir response
of 1.1 log10 decline and an end-of-treatment
response of 0.5 log10; and a third patient demonstrated a nadir
response of 2.5 log10 decline
and an end-of-treatment response of 2.2 log10. No serious adverse events have
been reported and there were no discontinuations from the patient portion
of this study. In an earlier
segment of the study, dosing in healthy volunteers showed evidence of
immune induction starting at 800 mg.
Tolerability in healthy volunteers was generally good, with no
serious adverse events. An
increased incidence of interferon-like side effects was seen at the 1200
and 1600 mg dose levels, with one discontinuation at 1200 mg and two
discontinuations at 1600 mg. The pharmacokinetic
(PK) and pharmacodynamic (PD) data from the healthy volunteer portion of
the Phase I Clinical Trial of ANA773 in HCV are being presented in a
poster at EASL titled, “PK/PD Assessment of a Phase I Healthy Volunteer
with ANA773, an Oral Inducer of Endogenous Interferons that Acts Via TLR7,
for the Treatment of HCV.”
·
Phase I Clinical Trial in Oncology. Anadys
continues to enroll patients in a Phase I study of ANA773 in oncology. The Company is currently dosing ANA773 at 800
mg, administered every other day.
Webcast of Conference Call
Anadys will host a conference call at 5:00 pm
Eastern Daylight Time today to discuss
its first quarter 2009 financial results and highlights and to provide an update on its
development programs, including a review of the ANA598 antiviral data that was
presented at EASL. A live webcast of the call
will be available online at 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 85383527. The webcast and telephone replay will be
available through May 7, 2009.
About Anadys
Anadys
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated
to improving patient care by developing novel medicines in the areas of
hepatitis C and oncology. For the treatment of chronic hepatitis C, the
Company is developing two potentially complementary agents, ANA598, a
non-nucleoside polymerase inhibitor and ANA773, an oral inducer of endogenous
interferons that acts via the TLR7 pathway.
The Company is also developing ANA773 for the treatment of cancer.
Safe Harbor
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 (i) the potency, safety and tolerability
profile of ANA598, which may not be duplicated in future cohorts at higher
doses or future clinical studies of longer duration; (ii) the potential for the
first Phase II study of ANA598 to demonstrate the impact of ANA598 on durable
clinical benefit (SVR) in HCV patients; (iii) the expectation that ANA598 will
be active in long-term studies in combination with pegylated interferon and
ribavirin and the ability to dose ANA598 for up to 48 weeks in future
combination studies; (iv) the ability of Anadys to transition into Phase II
studies of ANA598 during 2009; (v) the ability to proceed to the 2000mg dose
level in the ANA773 HCV patient study and the potential to see viral load
reduction with a favorable tolerability profile at the higher dose; and (vi)
expectations regarding the evolution of the market for HCV therapies. 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 and early clinical 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 ongoing
or 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 enter into transactions around its
product candidates, 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, 2008. 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
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Anadys Pharmaceuticals,
Inc. |
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Condensed Consolidated
Statements of Operations |
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(In thousands except
per share amounts) |
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(Unaudited) |
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||||||||
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|
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Three Months Ended March
31, |
||||||
|
|
|
2009 |
|
2008 |
||||
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,876 |
|
|
$ |
6,009 |
|
|
General and administrative |
|
|
2,055 |
|
|
|
2,045 |
|
|
Total
operating expenses (1) |
|
|
8,931 |
|
|
|
8,054 |
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income and other, net |
|
|
172 |
|
|
|
610 |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss (1) |
|
$ |
(8,759 |
) |
|
$ |
(7,444 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted (1) |
|
$ |
(0.30 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
Share
used in calculating net loss per share, |
|
|
|
|
|
|
|
|
|
basic
and diluted |
|
|
28,838 |
|
|
|
28,697 |
|
|
|
|
|
|
|
|
|
|
|
(1) Includes
non-cash operating expenses of $684 and $661 determined in accordance with
Statement of Financial Accounts Standards No. 123(R), “Share-Based Payment”
(SFAS No. 123(R)) or approximately $0.02 and
$0.02 effect on basic and diluted net loss per common share for the three
months ended March 31, 2009 and 2008, respectively. Research and development expense and general
and administrative expense includes $328 and $356 of non-cash operating
expenses determined in accordance with SFAS No. 123(R) for the three months
ended March 31, 2009. 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.
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Anadys Pharmaceuticals,
Inc. |
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Condensed Consolidated
Balance Sheets |
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(In thousands) |
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March 31, |
|
December 31, |
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2009 |
|
2008 |
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|
|
|
(Unaudited) |
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(Audited) |
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Assets |
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
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Cash,
cash equivalents and securities available-for-sale |
|
$ |
20,845 |
|
$ |
27,936 |
|||
|
Other
current assets |
|
|
2,095 |
|
|
2,202 |
|||
|
Noncurrent
assets |
|
|
1,243 |
|
|
1,536 |
|||
|
Total assets |
|
$ |
24,183 |
|
$ |
31,674 |
|||
|
|
|
|
|
|
|
|
|
|
|
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Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|||
|
|
|
|
|
|
|
|
|||
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Current
liabilities |
|
$ |
6,224 |
|
$ |
5,813 |
|||
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Other
long-term liabilities |
|
|
34 |
|
|
36 |
|||
|
Stockholders’
equity |
|
|
17,925 |
|
|
25,825 |
|||
|
Total liabilities and stockholders’
equity |
|
$ |
24,183 |
|
$ |
31,674 |
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