Company’s lead product, an inhaled version of loxapine, has a PDUFA date of October 11.
Alexza Pharmaceuticals entered into agreements with a group of investors to raise approximately $18 million in gross proceeds through a registered direct offering with the sale of common stock and warrants. The company estimates that net proceeds from the offering will be approximately $16.4 million. It intends to use the money for general corporate purposes including clinical trials, R&D, general and administrative, as well as manufacturing expenses.
The company agreed to sell a total of 6,685,183 units, each unit consisting of one share of common stock and one warrant to purchase 0.5 of a share of common stock at $2.70 per unit. The warrants will be exercisable six months after issuance at $3.30 per share and will expire five years from the date of issuance.
Alexza is working to develop products for the acute treatment of central nervous system conditions. Its technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, reportedly allows for rapid systemic drug delivery through deep lung inhalation.
AZ-004, Staccato loxapine, is Alexza’s lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza reported positive results from both of its AZ-004 Phase III trials, submitted an NDA in December 2009, and has a PDUFA date of October 11. In February Alexza established a partnership with Biovail Laboratories to develop and commercialize AZ-004 in the U.S. and Canada.
Additionally, AZ-007, Staccato zaleplon, is poised to enter Phase II development with the first trial projected to begin in the first half of next year. It is being developed for the treatment of insomnia in patients who have difficulty falling asleep, including those patients who awake in the middle of the night and have difficulty falling back asleep.