NeurogesX Reports First Quarter 2009 Results
Conference Call Scheduled Today at
European Commission Decision on Qutenza(TM) Expected in 1H 2009
Company to Provide Update on FDA review of Qutenza During Conference Call Today
– CHMP issued positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain
Upcoming 2009 Milestones:
– European Commission decision on MAA for Qutenza anticipated first half of 2009
– European commercial partnership for Qutenza targeted first half of 2009
– FDA PDUFA date of
During the first quarter of 2009, NeurogesX continued to focus on seeking regulatory approvals and on pre-commercialization activities for its lead product candidate Qutenza (formerly NGX-4010). On
The CHMP’s recommendation for the MAA, filed under the centralized procedure, is subject to a final decision by the European Commission, usually rendered approximately 60 to 90 days after the CHMP’s recommendation. In preparation for potential marketing authorization and commercialization, NeurogesX has continued active discussions with potential European marketing partners and anticipates completing a transaction in the first half of 2009.
Qutenza is also undergoing U.S. regulatory review, and the United States Food and Drug Administration (FDA) has scheduled a Prescription Drug User Fee Act (PDUFA) date of
First Quarter 2009 Financial Results
Total operating expenses for the first quarter of 2009 were approximately
Net loss for the first quarter of 2009 was approximately
Cash, cash equivalents and short-term investments were approximately
Currently, NeurogesX is primarily focused on completing the development through regulatory approval, of Qutenza for patients with PHN in
The CHMP’s positive opinion recommending E.U. approval of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain, was made in reliance on NeurogesX’ commitment to conduct certain post marketing studies of Qutenza following approval. Post-marketing commitments are often required by the CHMP as a condition for recommending approval. An open-label safety study of Qutenza in on-label indications is planned to be conducted following launch of Qutenza in the E.U. In addition, a protocol evaluating the clinical safety and efficacy of Qutenza in painful diabetic neuropathy will be discussed with the CHMP following approval of the MAA. It is anticipated that these studies could potentially be conducted and/or funded by a European commercial partner.
NGX-1998 is the Company’s second-generation, liquid formulation of the same active ingredient found in Qutenza. The liquid formulation is being developed to address neuropathic pain conditions, providing similar efficacy in a shorter treatment time versus Qutenza. NGX-1998 has been evaluated in three Phase 1 studies and is currently being considered for entry into Phase 2 evaluation, subject to receipt of additional funding.
NeurogesX is also seeking business development partners to advance its acetaminophen and opioid prodrug product candidates.
- NGX-9674 and NGX-5752, novel prodrugs of acetaminophen, have been evaluated in in vivo and in vitro preclinical studies and demonstrate approximately 10 times greater solubility in water versus acetaminophen.
- NGX-1576, a novel prodrug coupling acetaminophen to a liver protectant, has been evaluated in vitro and in vivo. Equivalent dose levels of NGX-1576 in mice produced significantly less liver toxicity than acetaminophen, while additional data demonstrated the production of equivalent plasma levels of acetaminophen.
- NGX-6052, the most advanced molecule synthesized in NeurogesX’ opioid prodrug platform, has been evaluated in proof of concept in vivo and in vitro preclinical studies for its potential to deliver therapeutic efficacy with a potential for an improved side effect profile and possible abuse-deterrent attributes.
Conference Call Details
The Company will hold its quarterly conference call today at
To participate, please dial 1-877-407-0789 (
A replay of the conference call will be available beginning
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 postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX’ late-stage product portfolio is led by its product candidate QutenzaTM, a dermal high-concentration capsaicin patch designed to manage pain associated with peripheral neuropathic pain conditions. NeurogesX submitted a new drug application (NDA) for Qutenza with the U.S. Food and Drug Administration (FDA) in
NeurogesX’ second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently evaluating the timing of entering Phase 2 development.
NeurogesX’ early stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs.
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 and outcome of regulatory decisions and the label approval being sought or that may be obtained with respect to the MAA for Qutenza in the European Union and the NDA for Qutenza with the FDA, including the timing of European Commission decision on the MAA and the PDUFA date for the NDA; NeurogesX’ plans, and expected timing, with regard to seeking partnerships for its product candidates; the sufficiency of cash resources to fund the NeurogesX’ operations through at least
NEUROGESX, INC. (A Development Stage Company) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended March 31, ---------------------------- 2009 2008 ------ ------ Operating expenses: Research and development(1) $2,326 $5,781 General and administrative(2) 2,189 2,487 ------ ------ Total operating expenses 4,515 8,268 ------ ------ Loss from operations (4,515) (8,268) Interest income 33 504 Interest expense (120) (243) Other income (expense), net -- 17 -------- -------- Net loss $(4,602) $(7,990) ======== ======== Basic and diluted net loss per share attributable to common stockholders $(0.26) $(0.46) ======== ======== Shares used to compute basic and diluted net loss per share attributable to common stockholders 17,568,600 17,468,395 ========== ========== Non-cash stock-based compensation expense included in operating expenses: (1) Research and development $259 $198 (2) General and administrative 248 201 ---- ---- $507 $399 ==== ====
NEUROGESX, INC. (A Development Stage Company) CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2009 2008 --------- ----------- (unaudited) (1) ----------- ----------- Assets Current assets: Cash and cash equivalents $6,561 $10,435 Short-term investments 12,286 14,071 Prepaid expenses and other current assets 362 412 Restricted cash 40 40 ------ ------- Total current assets 19,249 24,958 Property and equipment, net 420 468 Restricted cash 160 160 Other assets -- 4 ------- ------- Total assets $19,829 $25,590 ======= ======= Liabilities and Stockholders' Equity Current liabilities: Accounts payable $478 $370 Accrued compensation 601 1,039 Accrued research and development 623 1,067 Other accrued expenses 621 540 Notes payable - current portion 1,982 2,833 ------- ------- Total current liabilities 4,305 5,849 Non-current liabilities: Notes payable - non-current portion -- 191 Deferred rent 367 276 ------- ------- Total non-current liabilities 367 467 Commitments and contingencies Stockholders' equity: Common stock 18 18 Additional paid-in capital 209,877 209,370 Deferred stock-based compensation (1) (2) Accumulated other comprehensive income 9 32 Deficit accumulated during the development stage (194,746) (190,144) -------- -------- Total stockholders' equity 15,157 19,274 ------- ------- Total liabilities and stockholders' equity $19,829 $25,590 ======= ======= (1) The balance sheet at December 31, 2008, has been derived from the audited consolidated financial statements at that date. NeurogesX, Inc. Stephen Ghiglieri Chief Financial Officer (650) 358-3310 The Ruth Group Sara Ephraim (investors) (646) 536-7002 firstname.lastname@example.org Jason Rando (media) (646) 536-7025 email@example.com
SOURCE NeurogesX, Inc.