NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in treating aesthetic and therapeutic conditions, today announced results for the first quarter ended March 31, 2017.
Recent Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002)
- Completed enrollment for the SAKURA 1 & 2 Phase 3 pivotal trials of RT002 injectable for the treatment of glabellar (frown) lines. The SAKURA program is comprised of the two pivotal trials, plus a long-term safety trial that continues to enroll subjects. Revance plans to report topline results from the SAKURA 1 & 2 pivotal trials in the fourth quarter of 2017.
- Presented safety, efficacy and duration-of-effect results from Phase 2 trials for RT002 injectable for the treatment of glabellar lines and cervical dystonia at TOXINS 2017, the International Neurotoxin Association Conference.
- Presented BELMONT Phase 2 clinical data of RT002 injectable for the treatment of glabellar (frown) lines at the 2017 American Academy of Dermatology Annual Meeting.
- Updated Phase 2 program for RT002 injectable in the management of plantar fasciitis by expanding to a multi-center study with protocol updates. The company plans to report topline results in the fourth quarter of 2017.
- Expects to report 24-week results from all three cohorts of the Phase 2 open-label, sequential, dose-escalating study of RT002 for the treatment of cervical dystonia in the second quarter of 2017.
“Studies conducted to date with RT002 injectable involving both large and small muscles indicate not only a strong safety profile, but also that this next-generation neuromodulator can potentially deliver high response rates, long duration of effect and high patient satisfaction. These clinical results are like no other in the neuromodulator space,” said Dan Browne, President and Chief Executive Officer at Revance. “We expect to report results for our Phase 3 pivotal trials for glabellar lines, the 24-week Phase 2 results for cervical dystonia and topline Phase 2 results for our new indication, plantar fasciitis, all within the next seven months.”
Summary Financial Results
Cash and investments as of March 31, 2017 were $188.6 million.
Research and development expenses for the three months ended March 31, 2017 were $19.4 million compared to $12.4 million for the same period in 2016. The increase in research and development expenses is primarily due our SAKURA 1 and 2 Phase 3 pivotal trials of RT002 injectable.
General and administrative expenses for the three months ended March 31, 2017 were $7.8 million compared to $7.5 million for the same period in 2016. The increase in general and administrative expenses is primarily due to increased costs related to personnel, offset by a decrease in marketing expenses.
Total operating expenses for the three months ended March 31, 2017 were $27.2 million compared to $19.8 million for the same period in 2016. Stock-based compensation for the three months ended March 31, 2017 was $3.2 million. When excluding depreciation and stock-based compensation, total operating expenses for the three months ended March 31, 2017 were $23.7 million.
Net loss for the three months ended March 31, 2017 was $27.2 million compared to $19.9 million for the same period in 2016.
