REDWOOD CITY, Calif., May 8, 2012 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (“AcelRx”), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the first quarter ended March 31, 2012.
Net loss for the first quarter of 2012 was $7.1 million, or $0.36 per share, compared with a net loss of $3.2 million, or $0.30 per share, for the first quarter of 2011. Common shares used in calculating basic and diluted earnings per share were 19,607,483 for the first quarter of 2012 compared to 10,742,182 common shares for the first quarter of 2011.
During the first quarter of 2012, AcelRx recognized revenue of $329,000 resulting from reimbursement for work completed under a research grant from the US Army Medical Research and Material Command, or USAMRMC, for development of its ARX-04 product candidate, a Sufentanil NanoTab® for the treatment of moderate-to-severe acute pain.
Research and development expenses for the quarter ended March 31, 2012 totaled $4.8 million, compared with $1.9 million for the quarter ended March 31, 2011. The increase was primarily due to development expenses for ARX-01, the Sufentanil NanoTab PCA System, AcelRx’s lead product candidate for the treatment of post-operative pain. During the first quarter, AcelRx prepared for and initiated the first of three planned Phase 3 clinical trials, a randomized, double-blind, placebo-controlled efficacy and safety trial in adults with post-operative pain, following open-abdominal surgery. In April 2012, AcelRx initiated the second ARX-01 Phase 3 study, a randomized, open-label, parallel-group comparison of the efficacy and safety of the Sufentanil NanoTab PCA System to the standard of care, IV PCA with morphine, in the treatment of acute post-operative pain in adults immediately following major abdominal or orthopedic surgery.
General and administrative expenses were $2.1 million for the quarter ended March 31, 2012, compared with $1.6 million for the quarter ended March 31, 2011. This increase resulted primarily from expenses associated with market research and patent prosecution efforts as well as personnel related expenses, including stock-based compensation, and expenses associated with being a public company.
As of March 31, 2012, AcelRx had cash, cash equivalents and investments of $27.6 million, compared to $35.8 million at December 31, 2011.
“With two of our three planned Phase 3 clinical studies actively enrolling, and with the initiation of the third Phase 3 clinical study planned for the third quarter of 2012, we are looking forward to seeing top-line data from all three Phase 3 clinical trials by late 2012 or early 2013,” said Richard King, President and CEO of AcelRx. Mr. King added, “Based on our dialog with FDA, data from these studies should support an NDA filing, expected in the middle of 2013.”
Development Update
- In March 2012, AcelRx initiated the first of three planned Phase 3 clinical trials, a double-blind, placebo-controlled efficacy and safety trial of adult patients with post-operative pain following open-abdominal surgery. We expect top-line data for this trial in the second half of 2012.
- In April 2012, AcelRx initiated a second Phase 3 clinical trial, an open-label active-comparator study comparing ARX-01 to the current standard of care, IV PCA with morphine, in patients with post-operative pain following open-abdominal surgery or major orthopedic surgery. We expect top-line data for this trial in the second half of 2012.
- In the third quarter of 2012, AcelRx plans to initiate our third planned Phase 3 clinical trial, a double-blind, placebo-controlled efficacy and safety study of patients with post-operative pain following hip and knee replacement surgeries, with top-line data expected in late 2012 or early 2013.
Financial Outlook
AcelRx anticipates that research and development expenses for the remainder of 2012 and into 2013 will increase significantly as AcelRx seeks to execute and complete the Phase 3 clinical development program of ARX-01. Development of ARX-04 through Phase 2 clinical work and Phase 3 preparatory work is fully funded by a grant from USAMRMC. The development of ARX-04 beyond Phase 2 and initial preparations for Phase 3 is dependent on identification of sources of additional funding. Additionally, AcelRx anticipates modest increases in general and administrative expenses due to costs associated with operating as a public company and expansion of its corporate infrastructure to support ongoing development of its product candidates.
AcelRx believes its current cash, cash equivalents and investments are sufficient to fund operations into the first quarter of 2013.
About AcelRx Pharmaceuticals, Inc.
Based in Redwood City, CA, AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx’s lead product candidate, the ARX-01 Sufentanil NanoTab PCA System, which is currently in Phase 3 clinical development, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps. AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician’s office. A fourth product candidate, ARX-04, is a sufentanil product for the treatment of moderate-to-severe acute pain, and AcelRx plans to initiate a Phase 2 study funded by a grant from USAMRMC, contingent on approval of the proposed clinical protocol for the study by USAMRMC.
