Key Developments For Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc. (ALXA.O) (Consolidated Issue listed on NASDAQ Global Market)
Alexza Pharmaceuticals, Inc. To Raise $19.7 Million In Private Placement
Alexza Pharmaceuticals, Inc. announced that it has entered into a definitive agreement with various institutional investors to raise $19.7 million in a private placement of its common stock. Under the terms of the financing, Alexza is expected to sell approximately 8.1 million shares of common stock and warrants to purchase approximately 7.3 million shares of common stock at a total purchase price of $2.4325 per unit. On September 29, 2009, the closing price for the Company's common stock was $2.32 per share. The investors in this private placement will receive 7-year warrants, exercisable immediately, to purchase 0.9 shares of Alexza Common Stock for each share of common stock purchased. The warrant exercise price is $2.77 per share. Alexza expects to net approximately $19.1 million in the transaction, after deducting offering expenses. RBC Capital Markets acted as the sole placement agent for this offering. The closing of the offering is subject to certain customary conditions and is expected to occur on or about October 5, 2009. Proceeds from the financing will be used primarily for working capital and general corporate purposes.
Alexza Pharmaceuticals, Inc. Announces Preliminary Results From AZ-104 (Staccato Loxapine) Phase 2b Trial
Alexza Pharmaceuticals, Inc. announced the preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato loxapine) in patients with migraine headache. Both AZ-104 dose groups trended towards statistical significance, but the study did not meet its primary endpoint, which was defined as pain-relief at the 2-hour time point, compared to placebo. There were no serious adverse events in the clinical trial, and AZ-104 was generally safe and well tolerated in this patient population. AZ-104 was numerically superior to placebo in pain-relief at 2-hours post-dose, but these differences were not statistically significant. Pain relief was observed in 56% of patients receiving the 2.5 mg dose (p=0.11) and 54% of patients receiving the 1.25 mg dose (p=0.12), as compared to 45% of patients receiving placebo. Another commonly used measure of efficacy in migraine studies is the percentage of patients who are pain-free at 2 hours post-dose. Again, AZ-104 was numerically superior to placebo in this measure, but the differences were not statistically significant. Pain-free responders were 31% of the patients receiving the 2.5 mg dose and 27% of the patients receiving the 1.25 mg dose, as compared to 23% of the patients receiving placebo.
Alexza Pharmaceuticals, Inc. Announces Agreement To Acquire Symphony Allegro, Including All Rights To AZ-004, AZ-104 And AZ-002
Alexza Pharmaceuticals, Inc. announced that it has exercised its option to purchase all of the equity of Symphony Allegro. The purchase of Symphony Allegro is projected to close in Q3 2009. Alexza and Symphony Capital Partners, LP have negotiated new terms to satisfy the exercise price for Alexza's option exercise to acquire Symphony Allegro. Under the terms of the Amended and Restated Purchase Option Agreement, Alexza will: - issue Symphony Capital 10 million shares of Alexza Common Stock. - Issue Symphony Capital a five year warrant for five million shares of Alexza Common Stock at an exercise price of $2.26 per share, a 25% premium to the preceding 30 trading day average closing price, and cancel Symphony's currently outstanding 2 million shares warrant for Alexza Common Stock. - Pay Symphony certain percentages of cash payments that may be generated from future partnering transactions for AZ-004, AZ-104 and/or AZ-002, the product candidates that were licensed to Symphony Allegro. Upon closing of the transaction, Symphony Capital will own approximately 23% of the total Alexza Common Stock outstanding.
Alexza Pharmaceuticals, Inc. Comments on Long-Term Earnings Outlook
Alexza Pharmaceuticals, Inc. announced that it expects to continue to incur substantial and increasing net losses for the foreseeable future, and it may never achieve or maintain profitability.
Alexza Pharmaceuticals, Inc. Consolidates Operations to Focus Resources on AZ-004 (Staccato Loxapine) for Acute Agitation; Terminates AZ-003 (Staccato Fentanyl) Program with Endo Pharmaceuticals
Alexza Pharmaceuticals, Inc. announced that it has consolidated its operations, with a primary focus on the continued rapid development of AZ-004 (Staccato loxapine). The restructuring includes a workforce reduction of 52 employees, representing approximately 33% of the Company's total workforce. In addition, Alexza and Endo Pharmaceuticals, Inc. have agreed to mutually terminate their development agreement for AZ-003 (Staccato fentanyl), a product development candidate that has completed Phase 1 clinical testing. Alexza does not intend to commit additional resources to AZ-003 during 2009.
