-- NDA filing for dermal patch NGX-4010 in PHN expected in 2008 -- IND filing for liquid formulation NGX-1998 expected in first half of
-- NGX-4010 MAA under EMEA review for neuropathic pain
-- Closed $25 million private placement
SAN MATEO, Calif., March 26 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported financial results for the fourth quarter and full year ended December 31, 2007.
Anthony DiTonno, President and Chief Executive Officer, commented, "2007 was a positive year for NeurogesX in terms of moving our product candidates forward and achieving numerous key milestones. In September, we announced positive results from our second Phase 3 trial of our dermal patch drug candidate, NGX-4010, in postherpetic neuralgia (PHN). We expect to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) later this year in PHN. Additionally, we are continuing with the marketing authorization application (MAA) under the centralized procedure in the European Union, where our application was accepted by the European Medicines Agency (EMEA) in September 2007. We are evaluating our development program in painful diabetic neuropathy (PDN) and our clinical and regulatory strategies with regard to the painful HIV-distal sensory polyneuropathy (HIV-DSP) indication, in light of our recent Phase 3 trial in HIV-DSP that did not meet its primary endpoint. We remain on track to file an investigational new drug application (IND) for our high concentration capsaicin liquid formulation product candidate, NGX-1998, in the first half of 2008."
Regulatory and Commercialization Plans for NGX-4010
NeurogesX submitted an MAA for NGX-4010, which was accepted by the EMEA under the centralized filing procedure in September 2007. The Company's MAA seeks approval in the European Union for a broad indication of peripheral neuropathic pain, which includes PHN, HIV-DSP and PDN, among others. The submission was based upon existing clinical trial data, which as of the date of the filing included the Company's first two successful Phase 3 studies, one each in PHN and HIV-DSP. NeurogesX is evaluating strategies regarding its MAA that may include adding to the dossier the Company's second successful Phase 3 study in PHN (C117) and its second Phase 3 study in HIV-DSP (C119), in which the primary endpoint was not met, to potentially support broad label approval, or approval of a subset of indications in neuropathic pain.
NeurogesX expects to submit an NDA for NGX-4010 with the FDA in the second half of 2008 for PHN. The Company is currently evaluating its clinical and regulatory strategies with regard to the HIV-DSP indication, including the potential for conducting additional studies to support an approval in this indication.
NeurogesX retains exclusive worldwide commercialization rights for NGX- 4010 and intends to establish a focused specialty sales force in the United States to address its target market of pain centers and physicians. NeurogesX intends to enter into commercial partnerships for marketing and distribution outside the United States.
Fourth Quarter and Year-End 2007 Financial Results
For the three months ended December 31, 2007, total operating expenses were approximately $8.1 million, including $0.3 million of non-cash stock- based compensation expense, compared to total operating expenses of approximately $9.3 million, including $2.0 million of non-cash stock-based compensation expense, for the same period in 2006. After adjusting for non- cash stock-based compensation charges, operating expenses were $7.8 million for the three months ended December 31, 2007, compared to $7.3 million for the same period in 2006. Net loss per share attributable to common stockholders, which included the non-cash charges for accretion of preferred stock to redemption value, was $0.58 per share and $41.85 per share for the three months ended December 31, 2007 and 2006, respectively, based on weighted average shares of 13,570,572 and 384,565, respectively. The weighted average shares used in computing loss per share attributable to common stockholders excluded 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.
For the twelve months ended December 31, 2007, total operating expenses were approximately $32.8 million, compared to $27.0 million for the same period in 2006. Net loss per share attributable to common stockholders, which included the non-cash charges for accretion of preferred stock to redemption value, was $4.06 per share and $116.20 per share for the twelve months ended December 31, 2007 and 2006, respectively, based on weighted average shares of 9,017,627 and 356,600, respectively. Cash, cash equivalents and short-term investments were $52.9 million as of December 31, 2007.
Conference Call Details
The Company will hold a conference call today at 5:00 p.m. ET (2:00 p.m. PT). 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 March 26, 2008 at 8:00 p.m. ET (5:00 p.m. PT) and ending on April 5, 2008. The replay telephone number is 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 275941.
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 March 26, 2008 at approximately 6:00 p.m. ET. The replay will remain available until April 26, 2008.
NGX-4010 is a dermal patch containing capsaicin, a selective TRPV1 agonist, designed to manage peripheral neuropathic pain. NeurogesX has previously completed three Phase 3 studies in PHN, of which two met their primary endpoint. In the successful Phase 3 PHN studies, a single, 60-minute treatment with NGX-4010 applied directly to the site of pain reduced pain for up to 12 weeks. In addition to being studied in PHN, NGX-4010 was also studied in two Phase 3 clinical trials in painful HIV-DSP, one of which met its primary endpoint.
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, HIV-DSP and 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.
Safe Harbor Statement
This press release contains forward-looking statements within the
meaning 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, statements regarding regulatory
submissions, including the expected timing of such submissions, and the
potential scope of indications included in NeurogesX' expected NDA filing
with the FDA or covered by the potential MAA approval; 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 fail to demonstrate adequate therapeutic efficacy or may
have unexpected adverse side effects; positive results in clinical trials
may not be sufficient to obtain FDA or European regulatory approval; prior
Phase 3 studies that have not met their endpoints may impact timing of, or
prevent, regulatory approval; physician or patient reluctance to use
NGX-4010, or the inability of physicians to obtain sufficient reimbursement
for such procedures may limit product utilization if approved; 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 NGX-4010. For further information regarding these and
other risks related to NeurogesX' business, investors should consult
NeurogesX' filings with the Securities and Exchange Commission.
NeurogesX, Inc. The Ruth Group
Stephen Ghiglieri Stephanie Carrington / Elizabeth
Chief Financial Officer Scott (investors)
(650) 358-3310 (646) 536-7017 / 7014
Jason Rando (media)
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2007 2006 2007 2006
Research and development (1) $5,654 $6,601 $25,321 $20,919
General and administrative (2) 2,412 2,651 7,455 6,110
Total operating expenses 8,066 9,252 32,776 27,029
Loss from operations (8,066) (9,252) (32,776) (27,029)
Interest income 443 220 1,673 719
Interest expense (272) (345) (1,219) (563)
Other income (expense), net 6 (3,464) 366 (3,272)
Net loss (7,889) (12,841) (31,956) (30,145)
Accretion of redeemable
convertible preferred stock -- (3,254) (4,626) (11,293)
Loss attributable to common
stockholders ($7,889) ($16,095) ($36,582) ($41,438)
Net loss per common share-basic
Loss per share attributable to
common stockholders ($0.58) ($41.85) ($4.06) ($116.20)
Shares used to compute basic
and diluted loss per share
attributable to common
stockholders 13,570,572 384,565 9,017,627 356,600
compensation expense included
in operating expenses:
(1) Research and development $158 $302 $893 $644
(2) General and administrative 184 1,669 869 3,199
$342 $1,971 $1,762 $3,843
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
Cash and cash equivalents $31,478 $11,908
Short term investments 21,373 1,994
Prepaid expenses and other current assets 585 659
Total current assets 53,436 14,561
Property and equipment, net 453 159
Restricted cash 240 --
Other assets 56 98
Total assets $54,185 $14,818
Liabilities, Redeemable Convertible
Preferred Stock and Stockholders'
Accounts payable $1,712 $1,675
Accrued compensation 680 199
Accrued research and development 1,198 1,133
Other accrued expenses 1,848 990
Preferred stock warrant liability -- 7,549
Notes payable-current portion 3,859 2,437
Total current liabilities 9,297 13,983
Notes payable-non-current portion 3,024 6,737
Deferred rent 156 --
Accrued research and development-non-current 347 --
Total non-current liabilities 3,527 6,737
Redeemable convertible preferred stock,
$0.001 par value;
10,000,000 and 292,467,200 shares authorized
at December 31, 2007 and 2006, respectively;
0 and 117,386,300 shares issued and
outstanding at December 31, 2007 and 2006,
respectively; aggregate liquidation value of
$0 and $86,540 at December 31, 2007 and 2006,
respectively -- 116,164
Stockholders' equity (deficit):
Common stock, $0.001 par value;
100,000,000 and 21,966,666 shares
authorized at December 31, 2007 and 2006,
respectively; 17,096,806 and 386,309
shares issued and outstanding at December
31, 2007, and 2006, respectively 17 1
Additional paid-in capital 205,417 5,505
Deferred stock-based compensation (15) (45)
Accumulated other comprehensive income 51 --
Deficit accumulated during the
development stage (164,109) (127,527)
Total stockholders' equity (deficit) 41,361 (122,066)
Total liabilities, redeemable convertible
preferred stock and stockholders'
equity (deficit) $54,185 $14,818
|SOURCE NeurogesX, Inc.|
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