Published:
Inhibitex Reports Third Quarter 2009 Financial Results
ATLANTA - (BUSINESS WIRE) - Inhibitex, Inc. (Nasdaq: INHX), today announced its financial results
for the third quarter ended September 30, 2009. The Company held cash,
cash equivalents and short-term investments of $21.1 million at
September 30, 2009, as compared to $33.1 million at December 31, 2008.
"We continue to make progress on all fronts, including the advancement
of our differentiated antiviral development programs and most recently,
the completion of a financing that we believe strategically positions us
to develop both FV-100 and INX-189 through their respective clinical
proof of concept trials," stated Russell H. Plumb, President and CEO of
Inhibitex, Inc. "We continue to anticipate completing our Phase II
clinical trial of FV-100 in shingles patients around the middle of next
year, and subject to the successful completion of ongoing GLP studies,
believe we are on track to file an investigational new drug application
and initiate a Phase I clinical trial of INX-189 in the first half of
2010."
Third Quarter 2009 Financial Results
The Company reported a net loss for the third quarter of 2009 of $4.5
million, as compared to a net loss of $4.0 million in the third quarter
of last year. Basic and diluted net loss per share was $0.10 for the
third quarter of 2009 as compared to basic and diluted net loss per
share of $0.09 per share in the third quarter of 2008. The increase in
net loss and net loss per share in the third quarter of 2009 was the
result of higher research and development expense, lower revenues from
collaborative license and development agreements and lower net interest
income, offset in part by a reduction in general and administrative
expense.
Revenue decreased to $0.3 million in the third quarter of 2009 from $0.8
million in the third quarter of 2008. The $0.5 million decrease was
primarily the result of upfront license fees received by the Company in
2007 and 2008 being fully amortized to revenue as of the end of 2008,
and to a lesser extent, lower periodic research-associated support fees
received by the Company.
Research and development expense increased to $3.9 million in the third
quarter of 2009 from $3.5 million in the third quarter of 2008,
primarily due to a $0.5 million increase in direct costs incurred in
connection with the clinical development of FV-100 and the preclinical
development of INX-189, offset in part by a $0.1 million decrease in
other non-direct expenses.
General and administrative expense decreased to $0.8 million in the
third quarter of 2009 from $1.5 million in the third quarter of 2008.
This $0.7 million decrease consisted of a $0.3 million reduction in
depreciation and facility-related expenses due to a loss on rent accrual
in 2008 and a $0.4 million decrease in other expenses.
Financial Guidance
The Company updated its financial guidance in light of its recent
financing, the clinical status of FV-100 and its preclinical and
clinical development plans for INX-189. The Company currently
anticipates that it will have between $36-$37 million in cash, cash
equivalents and short-term investments on hand at the end of 2009, and
that it has sufficient financial resources to support its planned
operations through the end of 2011.
Financial guidance involves a high level of uncertainty and is subject
to numerous assumptions and factors. These factors include, but are not
limited to: the funding requirements and time it may take to conduct
preclinical research, formulate and manufacture clinical trial materials
and conduct clinical trials; the ability to enroll subjects or patients
in clinical trials on a timely basis, if at all, and whether the results
of these clinical trials are favorable; receiving regulatory approvals
on a timely basis to proceed with the clinical development of a drug
candidate; the cost of filing, prosecuting and enforcing patents or
other intellectual property rights; changes in the Company's strategy or
development plans in the future; and the level of general and
administrative expenses needed to support the Company's business
strategy and its publicly-traded status. In addition, the financial
guidance does not consider or reflect the potential financial or
operating impact of any additional alliances, licensing or collaboration
agreements, or other similar transactions that may occur in the future.
Recent Corporate Developments
FV-100 - The Company has approximately 60 sites initiated and
qualified to enroll patients in its Phase II clinical trial to evaluate
the safety and biologic activity of FV-100 for the treatment of shingles.
INX -189 âDuring the third quarter, the Company advanced INX-189,
its lead HCV protide polymerase inhibitor, into Good Laboratory Practice
(GLP) studies based upon the results of extensive preclinical in vitro
and in vivo studies.
NASDAQ Listing Transfer - In October 2009, the Company received
written notification from The Nasdaq Stock Market ("Nasdaq" ) stating
that the closing bid price of the Company's common stock had been at or
above $1.00 per share for 10 consecutive business days, and therefore
the Company had regained compliance with Nasdaq's Listing Rule
5550(a)(2) and its delisting matter has been closed.
Private Placement Financing - In October, the Company completed a
private placement of common stock and warrants to a group of new and
existing institutional investors, raising gross proceeds of
approximately $23 million. In connection with the private placement, the
Company is required to file a registration statement on Form S-3 with
the Securities and Exchange Commission to register the resale of shares
of common stock and the shares of common stock issuable upon the
exercise of the warrants issued pursuant to the financing.
Presentation at AASLD Meeting â Earlier this week, the Company
presented preclinical pharmacokinetic data on INX-189 in a poster at the
60th Annual Meeting of the American Association for the Study
of Liver Diseases (AASLD) in Boston, MA. A copy of the poster
presentation is available on the Company's website at www.inhibitex.com.
Conference Call and Webcast Information
Russell H. Plumb, president and chief executive officer of Inhibitex,
and other members of management will review the Company's third quarter
2009 operating results and financial position, as well as provide a
general update on the Company via a webcast and conference call today at
9:00 a.m. EDT. To access the conference call, please dial (877) 407-8033
(domestic) or (201) 689-8033 (international). A replay of the call will
be available from 11:00 a.m. EDT on November 6 until December 6, 2009 at
midnight. To access the replay, please dial (877) 660-6853 (domestic) or
(201) 612-7415 (international) and reference the account # 286 and the
conference id # 336098. A live audio webcast of the call and the
archived webcast will be available under the News and Events category on
the Inhibitex website at http://www.inhibitex.com.
About Shingles and FV-100
Shingles, also known as herpes zoster, is an infection caused by the
reactivation of varicella zoster virus (VZV), the same virus that causes
chicken pox. Worldwide, it is estimated that there are more than 2.5
million new cases of shingles each year. Shingles is generally
characterized by skin lesions, acute infection-related pain, and in many
cases, post herpetic neuralgia (PHN), a painful and sometimes
debilitating complication that can last for months or possibly years.
While shingles can develop in adolescents or adults of any age, it
occurs predominantly in individuals 40 years of age and older.
Published in vitro studies have demonstrated that FV-100, an
orally available bicyclic nucleoside analogue, is significantly more
potent against VZV, and can inhibit its replication substantially faster
than any other antiviral agent currently approved for the treatment of
shingles. Inhibitex believes these characteristics, plus a favorable
pharmacokinetic profile in Phase I studies, supports the potential of
FV-100 as a highly potent, once-daily oral therapy to reduce the
incidence and severity of shingles-related symptoms, including acute
pain and PHN.
About HCV and Protides
Hepatitis C is a disease of the liver caused by the hepatitis C virus
(HCV). It is estimated that approximately 4 million Americans and 170
million individuals worldwide are infected with HCV. HCV can cause
chronic liver disease, cirrhosis and cancer, and is the leading cause of
liver transplant in the United States.
Inhibitex is developing a series of proprietary phosphoramidates, or
protides, of nucleoside inhibitors that target the RNA-dependent RNA
polymerase (NS5b) of HCV. Protides are designed to by-pass the rate
limiting first step in the creation of active nucleoside triphosphate.
The Company believes that its protides possess several pharmacological
advantages over nucleosides alone and potentially other nucleotide
prodrugs. These advantages include greater potency, a rapid conversion
of the protide into its active form in the liver and potentially less
toxicity due to reduced systemic exposure of the nucleoside. INX-189,
the Company's lead compound from this series, is a protide of a 2'-C-methylguanosine
analogue that the Company believes is the most potent nucleotide or
nucleoside HCV polymerase inhibitor described in the literature to date.
The Company believes the results of preclinical studies of INX-189 to
date support its potential as a highly potent, once-a-day oral therapy
highly amenable to combination with other anti-virals for the treatment
of patients with chronic hepatitis C infection.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a
biopharmaceutical company focused on developing products to treat and
prevent serious infectious diseases. In addition to FV-100 and INX-189,
the Company has licensed the use of its proprietary MSCRAMM
protein technology to Wyeth for the development of staphylococcal
vaccines.
For additional information about the Company, please visit www.inhibitex.com.
Safe Harbor Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that
involve substantial risks and uncertainties. All statements, other than
historical facts included in this press release, including statements
regarding: the amount of cash that the Company expects to have on hand
at the end of 2009; the belief that a recent financing supports the
clinical development of both FV-100 and INX-189 through their respective
clinical proof of concept trials and the Company's planned operations
for at least the next two years; the anticipated time in which the
ongoing Phase II clinical trial of FV-100 will be completed; the
potential for FV-100 to be dosed once-a-day and reduce the incidence and
severity of shingles-related symptoms, including acute pain and PHN; the
Company's belief that its HCV protides possess several pharmacological
advantages over nucleosides alone and potentially other nucleoside
prodrugs; the results of recent preclinical studies of INX-189
supporting its potential as a highly potent, once-a-day oral therapy
highly amenable to combination with other anti-virals for the treatment
of patients with chronic hepatitis C infection; and the Company's plan
to file an investigational new drug application and initiate clinical
trials for INX-189 in the first half of 2010, are forward looking
statements. These intentions, expectations, or results may not be
achieved in the future and various important factors could cause actual
results or events to differ materially from the forward-looking
statements that the Company makes, including the risk of: the Company
not obtaining regulatory approval on a timely basis, or at all, to
advance the development of INX-189 into clinical trials; either the
Company, the FDA, or an investigational review board suspending or
terminating the clinical development of FV-100 for lack of safety,
manufacturing issues or other clinical reasons; FV-100 not demonstrating
sufficient efficacy in reducing the incidence and severity of
shingles-related symptoms, including acute pain and PHN, to be
clinically relevant or commercially viable; the results of ongoing or
future preclinical or clinical studies of INX-189 not supporting its
further development; obtaining, maintaining and protecting the
intellectual property incorporated into and supporting the commercial
viability of the Company's product candidates; maintaining expenses,
revenues and other cash expenditures substantially in line with planned
or anticipated levels; Wyeth not terminating or revising its agreement
with the Company; and other cautionary statements contained elsewhere
herein and in its Annual Report on Form 10-K for the year ended December
31, 2008, as filed with the Securities and Exchange Commission, or SEC,
on March 23, 2009 and its Quarterly Reports on Form 10-Q for the quarter
ended March 31, 2009 and June 30, 2009, as filed with the SEC on May 13,
2009 and August 12, 2009, respectively. Given these uncertainties, you
should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict
accurately, or over which it has no control. The Company's business,
financial condition, results of operations and prospects may change. The
Company may not update these forward-looking statements, even though its
situation may change in the future, unless it has obligations under the
Federal securities laws to update and disclose material developments
related to previously disclosed information. The Company qualifies all
of the information contained in this press release, and particularly its
forward-looking statements, by these cautionary statements.
Inhibitex and MSCRAMM are registered trademarks
of Inhibitex, Inc.
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INHIBITEX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
8,177,449
|
|
|
$
|
11,507,137
|
|
|
|
Short-term investments
|
|
|
12,901,906
|
|
|
|
21,634,880
|
|
|
|
Prepaid expenses and other current assets
|
|
|
934,172
|
|
|
|
621,797
|
|
|
|
Accounts receivable
|
|
|
79,443
|
|
|
|
108,558
|
|
|
|
Total current assets
|
|
|
22,092,970
|
|
|
|
33,872,372
|
|
|
|
Property and equipment, net.
|
|
|
1,698,141
|
|
|
|
2,328,707
|
|
|
|
Other long-term assets
|
|
|
138,039
|
|
|
|
31,876
|
|
|
|
Total assets
|
|
$
|
23,929,150
|
|
|
$
|
36,232,955
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,492,789
|
|
|
$
|
1,276,215
|
|
|
|
Accrued expenses
|
|
|
1,618,787
|
|
|
|
1,001,047
|
|
|
|
Current portion of notes payable
|
|
|
78,125
|
|
|
|
312,500
|
|
|
|
Current portion of capital lease obligations
|
|
|
201,472
|
|
|
|
254,291
|
|
|
|
Current portion of deferred revenue
|
|
|
441,667
|
|
|
|
441,667
|
|
|
|
Other current liabilities
|
|
|
202,373
|
|
|
|
224,922
|
|
|
|
Total current liabilities
|
|
|
4,035,213
|
|
|
|
3,510,642
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
Notes payable, net of current portion
|
|
|
546,875
|
|
|
|
390,625
|
|
|
|
Capital lease obligations, net of current portion
|
|
|
234,731
|
|
|
|
387,892
|
|
|
|
Deferred revenue, net of current portion
|
|
|
125,000
|
|
|
|
237,500
|
|
|
|
Other liabilities, net of current portion
|
|
|
1,143,411
|
|
|
|
1,279,994
|
|
|
|
Total long-term liabilities
|
|
|
2,050,017
|
|
|
|
2,296,011
|
|
|
|
Total liabilities
|
|
|
6,085,230
|
|
|
|
5,806,653
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
Preferred stock, $.001 par value; 5,000,000 shares authorized at
September 30, 2009 and December 31, 2008; none issued and outstanding
|
|
|
-
|
|
|
|
-
|
|
|
|
Common stock, $.001 par value; 150,000,000 and 75,000,000 shares
authorized at September 30, 2009 and December 31, 2008,
respectively; 43,547,136 and 43,380,570 shares issued and
outstanding at September 30, 2009 and December 31, 2008, respectively
|
|
|
43,547
|
|
|
|
43,381
|
|
|
|
Common stock warrants
|
|
|
13,619,076
|
|
|
|
13,742,630
|
|
|
|
Additional paid-in capital
|
|
|
244,366,603
|
|
|
|
243,825,057
|
|
|
|
Other comprehensive income
|
|
|
7,588
|
|
|
|
111,450
|
|
|
|
Accumulated deficit
|
|
|
(240,192,894
|
)
|
|
|
(227,296,216
|
)
|
|
|
Total stockholders' equity
|
|
|
17,843,920
|
|
|
|
30,426,302
|
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
23,929,150
|
|
|
$
|
36,232,955
|
|
|
|
INHIBITEX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
License fees and milestones
|
|
$
|
37,500
|
|
|
$
|
412,500
|
|
|
$
|
112,500
|
|
|
$
|
1,237,500
|
|
|
|
Collaborative research and development
|
|
|
250,000
|
|
|
|
375,000
|
|
|
|
750,000
|
|
|
|
1,125,000
|
|
|
|
Total revenue
|
|
|
287,500
|
|
|
|
787,500
|
|
|
|
862,500
|
|
|
|
2,362,500
|
|
|
|
Operating expense:
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,945,464
|
|
|
|
3,468,184
|
|
|
|
11,123,072
|
|
|
|
8,982,333
|
|
|
|
General and administrative
|
|
|
831,264
|
|
|
|
1,519,205
|
|
|
|
2,840,108
|
|
|
|
4,083,112
|
|
|
|
Total operating expense
|
|
|
4,776,728
|
|
|
|
4,987,389
|
|
|
|
13,963,180
|
|
|
|
13,065,445
|
|
|
|
Loss from operations
|
|
|
(4,489,228
|
)
|
|
|
(4,199,889
|
)
|
|
|
(13,100,680
|
)
|
|
|
(10,702,945
|
)
|
|
|
Other income, net
|
|
|
1,562
|
|
|
|
5,077
|
|
|
|
39,634
|
|
|
|
19,557
|
|
|
|
Interest income, net
|
|
|
15,929
|
|
|
|
239,280
|
|
|
|
164,368
|
|
|
|
1,071,182
|
|
|
|
Net loss
|
|
$
|
(4,471,737
|
)
|
|
$
|
(3,955,532
|
)
|
|
$
|
(12,896,678
|
)
|
|
$
|
(9,612,206
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
Share
|
|
$
|
(0.10
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(0.30
|
)
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used to compute basic and diluted net loss
per share
|
|
|
43,545,057
|
|
|
|
43,273,487
|
|
|
|
43,499,678
|
|
|
|
42,992,372
|
|
|
Inhibitex, Inc. Russell H. Plumb, 678-746-1136 Chief Executive
Officer rplumb@inhibitex.com
Copyright © 2009, Business Wire, Inc., All rights reserved. Copyright © 2009, NewsBlaze, Daily News
Tags: Business wire, Biotechnology, georgia, Health, Pharmaceuticals
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