On March 12th, Acelrx (ACRX) released a pr covering its last quarter's earnings. In the pr, the company stated that it had cash to last only to Q3 of this year. However, in the official conference call minutes, the company clearly stated that it has cash thru Q3 2014. Subsequently, the stock sold off hard afterwards, only to rebound significantly as some investors and traders caught the error. The company has been made aware of the error, but so far has not commented on the issue. I expect a pr shortly from the company clarifying the error.
ACRX in my estimation is trading over $1 to $2 dollars below its speculation value.
The company is developing ARX-01, the Sufentanil NanoTab PCA System, for the management of acute post-operative pain in adult patients during hospitalization. The company believes that ARX-01 would compete with a number of opioid-based treatment options that are currently available. The market for opioids for post-operative pain is large and competitive. The primary competition for ARX-01 is the IV PCA pump, which is widely used in the post-operative setting. Leading manufacturers of IV PCA pumps include Hospira (HSP), CareFusion Corporation (CFN), Baxter International (BAX), Curlin Medical and Smiths Medical. The most common opioids used to treat post-operative pain are morphine, hydromorphone and fentanyl, all of which are available as generics. Also available on the market is the Avancen Medication on Demand, Oral PCA Device developed by Avancen MOD Corporation. Also in development is MoxDuo, an orally administered, fixed ratio combination of morphine and oxycodone being developed by QRx Pharma (QRXPF.PK), an Australian company. This product is also in development as an IV product.
Upcoming milestones
The company has the following upcoming milestones in 2013.
Program | Event | Expected Date |
ARX-01 | Pivotal Phase 3 placebo -controlled trial results (abdominal pain) Data released: Positive results | 1Q/2013 |
ARX-01 | Pivotal Phase 3 placebo -controlled trial results (orthopedic) Data released: Positive results | 1Q/2013 |
ARX-01 | NDA submitted in post-operative pain | 3Q/2013 |
ARX-04 | Phase 2 trial results | 2013 |
I will have more coverage next week on ACRX, stay tuned!