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AcelRx Pharmaceuticals Reports Fourth Quarter and Full-Year 2012 Financial Results
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"We made important strides in the advancement of our sublingual Sufentanil NanoTab PCA System for the management of moderate to severe post-operative pain in 2012 and early 2013. We announced positive results from two completed Phase 3 clinical trials, and we expect the results from our third and final planned Phase 3 trial of the NanoTab System in the second quarter of 2013," stated
Net loss for the fourth quarter of 2012 was
During the fourth quarter of 2012, AcelRx recognized revenue of
Research and development, or R&D, expenses for the quarter ended
For the year ended
As of
Review of Recent Accomplishments and Corporate Update
- On
March 4, 2013 , AcelRx announced positive top-line results from a pivotal Phase 3 double-blind, placebo-controlled efficacy and safety clinical trial for the NanoTab System. This trial involved 178 adult patients recruited at 13 U.S. sites following major open abdominal surgery, and focused on the management of acute pain for up to 72 hours after the first study dose was given shortly after completion of surgery. The primary endpoint for this trial was the time weighted summed pain intensity difference to baseline over 48 hours, orSPID -48. The top-line data demonstrated that patients receiving sufentanil NanoTabs realized a significantly greaterSPID -48 during the study period than placebo-treated patients (p=0.001). Secondary endpoint data also showed that 24 hours and 72 hours after first dose, theSPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004, respectively). Further, sufentanil NanoTab treatment in this study was well tolerated, with the rate of adverse events being similar in both the active and placebo groups, and adverse events were generally mild to moderate in nature. - In
November 2012 , AcelRx announced positive top-line results for the NanoTab System in a Phase 3 open-label, active-comparator study evaluating the efficacy and safety of the Sufentanil NanoTab System versus IV PCA with morphine, a frequently used post-operative pain treatment in the hospital setting. The top-line data showed that the NanoTab System met its primary endpoint of non-inferiority in patient global assessment, orPGA , with method of pain control in comparison to IV PCA with morphine. Additional analyses also showed that the NanoTab System was statistically significantly superior to IV PCA morphine for thePGA measurement. In addition, using validated assessment tools, nurses managing patients in the study and the patients themselves reported that they had significantly greater Overall Satisfaction with the NanoTab System compared to IV PCA morphine and significantly greater Overall Ease of Care with the NanoTab System compared to IV PCA morphine. - A second placebo-controlled Phase 3 trial with the Sufentanil NanoTab PCA System continues to enroll patients following hip or knee replacement surgery with a target of enrolling approximately 400 patients. Dosing of the final subject in this study is expected in late March or early
April 2013 and top-line results should be available during the second quarter of 2013. The primary endpoint for the orthopedic placebo-controlled Phase 3 study is the sum of pain intensity difference to baseline over 48 hours, orSPID -48. - In early
November 2012 , AcelRx dosed the first patient in a Phase 2 study for ARX-04, its single dose sufentanil NanoTab product candidate for the management of acute pain. The study is funded by a grant from theU.S. Army Medical Research and Materiel Command, or USAMRMC, and enrolled approximately 100 patients following bunionectomy surgery, randomizing them into one of three groups to receive one of two sufentanil NanoTab dosage amounts (20 mcg or 30 mcg) or placebo. Dosing has been completed and we expect to announce top-line results for this trial in the second quarter of 2013. - In
October 2012 , theEuropean Medicines Agency , or EMA, notified AcelRx that it will permit registration of the Sufentanil NanoTab PCA System via the centralized procedure. This procedure will allow AcelRx to submit a single Marketing Authorization Application to the EMA for approval to market ARX-01 in all 27 EU member states, as well as in the 4European Free Trade Association countries. - In
December 2012 , AcelRx completed a public offering of common stock resulting in gross proceeds of$48 million ,$44 million in net proceeds after deducting commissions and offering expenses. - During 2012, the U.S. Patent and Trademark Office, or USPTO, issued five patents covering AcelRx's proprietary NanoTab technology and in early 2013, the USPTO issued the first NanoTab System device related patent. AcelRx has now received a total of six U.S. patents and two European patents underpinning its four product development programs, proprietary NanoTab technology and NanoTab System device.
Financial Outlook
AcelRx anticipates that quarterly R&D expenses for both the first and second quarters of 2013 will be in line with, or modestly higher than the R&D expenses experienced in fourth quarter of 2012 as AcelRx conducts and completes the Phase 3 clinical trials and prepares an NDA for the NanoTab System, and completes the ARX-04 Phase 2 clinical study. The development of ARX-04 beyond Phase 2 is dependent on the identification of additional funding from USAMRMC or other sources. Additionally, AcelRx anticipates modest increases in general and administrative expenses due to costs associated with commercial preparations for launch of the NanoTab System in the US, and as AcelRx expands its corporate infrastructure to support development of its product candidates.
AcelRx believes its current cash, cash equivalents and investments are sufficient to fund operations into the third quarter of 2014.
Conference Call
AcelRx will conduct a conference call and webcast today,
About
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future clinical development of
SELECTED FINANCIAL DATA |
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(in thousands, except per share data) |
|||||||
(unaudited) |
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Three Months Ended |
Twelve Months Ended |
||||||
December 31, |
December 31, |
||||||
2012 |
2011 |
2012 |
2011 |
||||
Statement of Operations Data |
|||||||
Research grant revenue |
$ 1,675 |
$ 624 |
$ 2,394 |
$ 1,072 |
|||
Operating expenses: |
|||||||
Research and development (1) |
7,795 |
4,702 |
24,908 |
13,624 |
|||
General and administrative (1) |
1,909 |
1,715 |
7,199 |
6,800 |
|||
Total operating expenses |
9,704 |
6,417 |
32,107 |
20,424 |
|||
Loss from operations |
(8,029) |
(5,793) |
(29,713) |
(19,352) |
|||
Interest expense |
(518) |
(417) |
(2,283) |
(2,309) |
|||
Interest income and Other income (expense), net |
(1,975) |
(163) |
(1,367) |
1,560 |
|||
Net loss |
$ (10,522) |
$ (6,373) |
$ (33,363) |
$ (20,101) |
|||
Basic and diluted net loss per common share |
$ (0.41) |
$ (0.33) |
$ (1.51) |
$ (1.16) |
|||
Shares used in computing basic and diluted net loss per common share |
25,588 |
19,568 |
22,125 |
17,345 |
|||
(1) Includes the following noncash, stock-based compensation expense: |
|||||||
Research and development |
$ 236 |
$ 207 |
$ 998 |
$ 785 |
|||
General and administrative |
281 |
280 |
1,152 |
1,048 |
|||
Total non-cash, stock-based expense |
$ 517 |
$ 487 |
$ 2,150 |
$ 1,833 |
|||
December 31, 2012 |
December 31, 2011 |
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Balance Sheet Data |
|||||||
Cash, cash equivalents and investments |
$ 59,763 |
$ 35,785 |
|||||
Total assets |
64,520 |
40,835 |
|||||
Total liabilities |
30,673 |
23,367 |
|||||
Total stockholders' equity |
33,847 |
17,468 |
SOURCE
Jim Welch, Chief Financial Officer, +1-650-216-3511, jwelch@acelrx.com