- IND for liquid formulation, NGX-1998, expected to be opened and commencement of clinical development expected in second quarter of 2008 - NDA submission for dermal patch, NGX-4010, in PHN expected in second half
- NGX-4010 MAA under EMEA review for peripheral neuropathic pain
SAN MATEO, Calif., May 15 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the first quarter of 2008.
Anthony DiTonno, President and CEO, commented, "We are focused on achieving our overall goal of receiving marketing approval for our lead product candidate, NGX-4010 in the United States and Europe. Following our recent meeting with the U.S. Food and Drug Administration (FDA), we believe that we are on track to file a new drug application (NDA) later this year for the postherpetic neuralgia (PHN) indication. Our marketing authorization application (MAA) was accepted by the European Medicines Agency (EMEA) in September of last year under the centralized procedure. We have been granted an extension for our response to the Day 120 questions in order to include additional clinical data and plan to submit our response in the third quarter of 2008."
Mr. DiTonno continued, "During the second quarter of 2008, we plan to open an investigational new drug (IND) application for our second product candidate, NGX-1998, a liquid formulation of capsaicin, the same active ingredient in our lead product candidate, NGX-4010. We are evaluating our clinical program for NGX-1998 in a range of neuropathic pain conditions."
First Quarter 2008 Financial Results
Total operating expenses for the first quarter of 2008 were approximately $8.3 million, including $399,000 of non-cash stock-based compensation expense, compared to total operating expenses of approximately $7.8 million, including $830,000 of non-cash stock-based compensation, for the first quarter of 2007. The increase in operating expenses was attributable to increased regulatory expenses in support of our MAA filing and preparation for an NDA filing later this year, higher general and administrative expenses due to increased infrastructure in support of NeurogesX' growth and the costs of being a public company as well as increased marketing expenses as the Company prepares for the possibility of transitioning to a commercial enterprise. These increases were partially offset by a decrease in clinical study related costs associated with NGX-4010.
Net loss for the first quarter of 2008 was approximately $8.0 million compared to a net loss of $7.9 million for the first quarter of 2007. Net loss per share attributable to common stockholders, was $0.46 per share and $17.25 per share for the three months ended March 31, 2008 and 2007, respectively, based on weighted average shares outstanding of 17,468,395 and 658,364, respectively. The net loss per share attributable to common stockholders in the three months ended March 31, 2007 included a non-cash charge for accretion of preferred stock to redemption value. The weighted average shares used in computing loss per share attributable to common stockholders exclude anti-dilutive securities such as stock options and warrants and also redeemable preferred stock in periods prior to their conversion to common stock upon completion of NeurogesX' initial public offering in May 2007.
Cash, cash equivalents and short-term investments were $46.4 million as of March 31, 2008.
Conference Call Details
The Company will hold a conference call today at 9:00 a.m. Eastern time (6:00 a.m. Pacific time). To participate in the conference call, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). In addition, a dial-up replay of the conference call will be available beginning May 15, 2008 at 12:00 p.m. Eastern time (9:00 a.m. Pacific time) and ending on May 25, 2008. The replay telephone number is 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 284128.
A live web cast of the call will also be available from the Investor Relations section on the corporate web site at http://www.neurogesx.com. A web cast replay can be accessed on the corporate web site beginning May 15, 2008 at the same time as the conference call and will remain on the site for one month ending June 15, 2008.
About NeurogesX, Inc.
NeurogesX (Nasdaq: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including PHN, painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate NGX-4010, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions that NeurogesX believes offers significant advantages over other pain therapies. NeurogesX' MAA to the EMEA was accepted for review in September 2007 and NeurogesX plans to file an NDA with the FDA in 2008 for PHN.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of
the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX
disclaims any intent or obligation to update these forward-looking
statements, and claims the protection of the Safe Harbor for
forward-looking statements contained in the Act. Examples of such
statements include, but are not limited to, the expected timing of
regulatory filings with respect to NeurogesX' product candidates, including
for NGX-4010 the potential filing of an NDA and the filing of additional
clinical data with respect to NeurogesX' MAA, and for NGX-1998 the filing
of an IND; the timing of initiation of clinical development of NGX-1998 and
the expected benefits of NeurogesX' potential products, including its lead
product candidate NGX-4010. Such statements are based on management's
current expectations, but actual results may differ materially due to
various risks and uncertainties, including, but not limited to, NeurogesX'
product candidates may have unexpected adverse side effects or inadequate
therapeutic efficacy; positive results in clinical trials may not be
sufficient to obtain FDA or European regulatory approval; physician or
patient reluctance to use NGX-4010, if approved, or the inability of
physicians to obtain sufficient reimbursement for such procedures;
potential alternative therapies; maintaining adequate patent or trade
secret protection without violating the intellectual property rights of
others; and other difficulties or delays in clinical development, obtaining
regulatory approval, market acceptance and commercialization of NeurogesX'
product candidates and the advantages of NeurogesX' product candidates over
other pain therapies. For further information regarding these and other
risks related to NeurogesX' business, investors should consult NeurogesX'
filings with the Securities and Exchange Commission.
Chief Financial Officer
The Ruth Group
Stephanie Carrington / Jared Hoffman (investors)
(646) 536-7017 / 7013
Jason Rando (media)
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
Three Months Ended March 31,
Research and development(1) $5,781 $6,196
General and administrative(2) 2,487 1,653
Total operating expenses 8,268 7,849
Loss from operations (8,268) (7,849)
Interest income 504 203
Interest expense (243) (332)
Other income 17 59
Net loss (7,990) (7,919)
Accretion of redeemable convertible
preferred stock - (3,437)
Loss attributable to common stockholders $(7,990) $(11,356)
Net loss per common share - basic and diluted:
Loss per share attributable to
common stockholders $(0.46) $(17.25)
Shares used to compute basic and
diluted loss per share attributable
to common stockholders 17,468,395 658,364
Non-cash stock-based compensation expense
included in operating expenses:
(1) Research and development $198 $348
(2) General and administrative 201 482
(A Development Stage Company)
Condensed Consolidated Balance Sheets
31, 2008 31, 2007 (1)
Cash and cash equivalents $12,370 $31,478
Short term investments 33,983 21,373
Prepaid expenses and other current assets 332 585
Total current assets 46,685 53,436
Property and equipment, net 477 453
Restricted cash 240 240
Other assets 45 56
Total assets $47,447 $54,185
Liabilities and Stockholders' Equity
Accounts payable $941 $1,712
Accrued compensation 643 680
Accrued research and development 2,555 1,198
Other accrued expenses 856 1,848
Notes payable - current portion 3,981 3,859
Total current liabilities 8,976 9,297
Notes payable - non-current portion 1,982 3,024
Deferred rent 227 156
Accrued research and development
- non-current - 347
Total non-current liabilities 2,209 3,527
Common stock 17 17
Additional paid-in capital 208,103 205,417
Deferred stock-based compensation (12) (15)
Accumulated other comprehensive income 253 51
Deficit accumulated during the
development stage (172,099) (164,109)
Total stockholders' equity 36,262 41,361
Total liabilities and stockholders' equity $47,447 $54,185
(1) The balance sheet at December 31, 2007 has been derived from the
audited consolidated financial statements at that date.
|SOURCE NeurogesX, Inc.|
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