ATXI is a specialty pharmaceutical company developing an intravenous (IV) formulation of tramadol HCI for post-operative pain. Tramadol is a synthetic dual-acting opioid with a well-established efficacy and safety profile, and has been used throughout the world for more than 30 years.
Oral tramadol is currently approved for adults and marketed in the US and physicians are already familiar with the oral dosage of the drug. Parenteral (non-oral) tramadol is approved and used for the management of moderate to moderately severe postoperative pain throughout much of the world, but there is no parenteral formulation currently available in the US. ATXI expects that the introduction of an IV formulation in the US will address the current market need for an intravenous dosage of tramadol in the postoperative setting.
ATXI has an exclusive license to develop and commercialize IV Tramadol in the US. It also plans to seek additional products and to develop them in the acute/intensive care hospital market. In 2016, ATXI completed a pharmacokinetics, or PK, study for IV Tramadol in healthy volunteers as well as an End-of-Phase 2, or EOP2, meeting with the FDA.
The company plans to initiate a Phase 3 development program of IV Tramadol in 2017. Specifically, the company intends to conduct two pivotal Phase 3 trials for IV Tramadol with the first trial being on patients following bunionectomy (surgery to remove bunions) in 3Q17. ATXI expects to have topline data as early as 2Q18. ATXI then plans to initiate the second Phase 3 trial in patients with moderate-to-severe pain following abdominoplasty (tummy tuck cosmetic surgery) in 3Q18, upon successful completion of the bunionectomy study. Topline data from this second trial could be available as early as mid-2019.
ATXU also plans to conduct an open-label safety study, which will run concurrently with the two Phase 3 trials. If these studies are successful, ATXI plans to submit a new drug application, or an NDA, for IV Tramadol to treat moderate to moderately severe postoperative pain by the end of 2019.
In terms of the financials, as is the case with many development stage pharma companies, ATXI has no revenue and has never been profitable. It expects to incur losses for the foreseeable future. Its operating loss for the three months ended March 31, 2017 was about $500K It currently has no drug products for sale, and only one drug product candidate, IV Tramadol. On a final note, this is a tiny offering at 5.5 million shares and there will be just 10 million shares outstanding after it starts trading which computes to a market cap of roughly $100 million. That makes it a micro-cap stock and that also makes it quite speculative.