VANCOUVER, June 14, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) said today that its shareholders have approved the terms of the $10 million brokered private placement equity offering previously announced by the Company May 2. The approval triggers the conversion of the subscription receipts sold as part of the financing making the full $10 million raised available to the Company for development of its lead product davunetide.
Davunetide is proceeding in a fully enrolled pivotal clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The trial is expected to complete patient dosing and release top-line data by late 2012. This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
Gordon McCauley, President and CEO of Allon Therapeutics, said the shareholder vote was undertaken in conjunction with the Company's Annual General Meeting (AGM) on Wednesday, June 13, 2012. "The financing ensures we have the resources needed to complete the trial and data analysis and to advance davunetide towards commercialization," McCauley said. "PSP is a devastating neurodegenerative disease with no approved treatments and a market potential in excess of $700 million in the U.S. and Europe."
The Company now looks forward to completing the pivotal study in PSP. "We are grateful for our shareholders' continued support as we move toward pivotal data at the end of this year. Our shareholders stand with thousands of patients, caregivers, families, and health professionals in search of a treatment for this debilitating and fatal disease", McCauley said.
Shareholders also re-elected the Company's Board of Directors: Dr. James J. Miller, Gordon C. McCauley, Dr. Anthony G. Phillips, Professor Illana Gozes, Frank Holler, Dr. Martin Barkin and Michael Aldridge.
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon's lead drug davunetide is proceeding in a pivotal clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The trial is fully enrolled and is expected to complete patient dosing and release top-line data by late 2012. This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and in positive biomarker data. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC".
Forward Looking Statements
Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management's outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon's dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon's public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
SOURCE Allon Therapeutics Inc.