Even with a beefed up international commercial partnership, a public offering, restructuring and layoffs, Alexza Pharmaceuticals ($ALXA) has disclosed that its cash could run out by year-end. And so stakes increase even further over the FDA's pending evaluation of Adasuve, the company's inhaled, fast-acting, vaporized formulation of the antipsychotic drug loxapine.
Mountain View, CA-based Alexza just can't catch a break. As of Dec. 31, the company said it had just $16.9 million in cash, equivalents and securities on hand. And after taking steps earlier this year to raise more than $20 million in a public offering, slash 38% of its workforce (29 jobs), and boost its international commercial partnership stake with Grupo Ferrer, the company reported that current cash burn rates will only carry it through the 2012 fourth quarter.
Alexza is struggling to gain FDA approval for Adasuve, which improves on the long-used oral version of loxapine to treat adults for schizophrenia-related agitation or bipolar I disorder. The drug is housed in the company's Staccato inhalation device, which delivers a vapor directly to the lungs and subsequently reaches the bloodstream quickly.
We learned in January that the FDA delayed its review deadline from Feb. 4 to May 4, in order to review how Alexza is addressing changes to safety and dosage guidelines recommended by an FDA panel of experts in December. Its decision, clearly, could make or break the company. So May 4 could be Doomsday or Christmas. An FDA-approved Adasuve would compete with injectable drugs made by companies including Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY).
Alexza booked a $9.7 million net loss during the fiscal 2011 fourth quarter and $40.5 million net loss for the fiscal year that ended Dec. 31.
- read the financials release