Press Releases<< Back
Aradigm Announces Third Quarter 2010 Financial Results
The Company recorded net income for the third quarter of 2010 of
Revenue of approximately
The Company announced that:
October 20, 2010, the Company announced positive top line data from its recently concluded 6-month Phase 2bstudy (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis. Statistical significance was achieved in the primary endpoint and one of the secondary endpoints. The primary endpoint - the mean change in Pseudomonas aeruginosa density in sputum from baseline to day 28 - was met. In the full analysis population*, there was a significant mean reduction of 4.2 log10 units in the ARD-3150 group, reflecting an almost sixteen-thousand fold decrease in bacterial load, versus a very small mean decrease of 0.1 log10 units in the placebo group (p=0.004). Secondary endpoint analysis showed that 17 subjects in the placebo group required supplemental antibiotics for respiratory-related infections versus 8 subjects in the ARD-3150 group (p=0.05). Positive trends were observed in the key area of pulmonary exacerbations. The median time to first exacerbation was 58 days in the placebo group versus 134 days in the ARD-3150 group and there were fewer exacerbations in the treatment group compared to the placebo group.
September 20, 2010, the Company closed the transaction contemplated by the previously announced July 30, 2010Stock Purchase Agreement with Novo Nordisk A/S. At the closing, the Company issued 26 million shares of the Company's common stock to Novo Nordisk A/Sin a private placement as consideration for the termination of a promissory note in favor of Novo Nordisk A/Sunder which approximately $9.1 millionwas outstanding on July 30, 2010, representing an effective price per share of $0.3505. The promissory note that was terminated at closing represented a loan that was made by Novo Nordisk A/Sto the Company in 2006 in the principal amount of $7.5 million, with interest accruing at 5% per annum.
September 23, 2010, the Company received proceeds of approximately $891,000from the exercise of all of the warrants to purchase an aggregate of 7,527,214 shares of the Company's common stock that were issued in the private placement that closed on June 21, 2010. The warrants became exercisable following the Company's Special Meeting of Shareholders held on September 14, 2010, at which the Company obtained the requisite approval from the Company's shareholders on all three proposals presented at the Special Meeting to approve an amendment to the Company's Amended and Restated Articles of Incorporation to increase the total number of authorized shares of the Company's common stock.
November 2, 2010, the Company announced that it received notification from the U.S. Internal Revenue Service( IRS) that it was approved to receive three grants in the amount of $244,479.25each for qualified investments in three qualifying therapeutic discovery projects. In July 2010, the Company applied for grants for three projects under the Qualifying Therapeutic Discovery Project. The three projects were: 1) ARD-3150 Liposomal Ciprofloxacin for the Treatment of Non-CF Bronchiectasis, 2) ARD-3100 Liposomal Ciprofloxacin for the Treatment of Non-CF Bronchiectasis and 3) ARD-3100 Liposomal Ciprofloxacin for the Treatment of Cystic Fibrosis. After a determination by U.S. Department of Health and Human Services(HHS) that all three projects met the definition of a "qualifying therapeutic discovery project", the IRScertified the qualifying investment and approved the award amount of $244,479.25per project, for a total of $733,437.75in awards to the Company. The qualified investments represent 2009 research and development expenses; there are no future performance obligations related to these grants.
November 4, 2010, the Company announced that it appointed Tamar D. Howson to its board of directors. Ms. Howson brings significant business development and life sciences industry expertise developed through her career as a senior professional at several leading pharmaceutical companies and as an advisor to several investor funds. She served as Senior Vice President of Corporate and Business Development and was a member of the executive committee at Bristol-Myers Squibb Company(Bristol-Myers) from 2001 until 2007. During her tenure at Bristol-Myers, Ms. Howson was responsible for leading the company's efforts in external alliances, licensing and acquisitions. From 1991 to 2000, Ms. Howson served as Senior Vice President and Director of Business Development at SmithKline Beecham plc, a global pharmaceutical company. She also managed SR One Ltd., a venture capital fund of SmithKline Beecham, plc. From 1990 to 1991, Ms. Howson held the position of Vice President, Venture Investments at Johnston Associates, Inc.,, and from 1987 to 1990, she served as Director of Worldwide Business Development and Licensing for Squibb Corporation. She previously served as Executive Vice President of Corporate Development for Lexicon Pharmaceuticals, Inc.and on the boards of Ariad Pharmaceuticals, Inc., SkyePharma, plc, NPS Pharmaceuticals, Inc., Targacept, Inc., and the Healthcare Businesswomen's Association. Ms. Howson received her MBA in finance and international business from Columbia University. She holds a MS from the City College of New Yorkand a BS from Technion in Israel.
"The completion this quarter of two key financial transactions allowed
us to significantly strengthen our balance sheet by eliminating all
outstanding debt and adding to our cash reserves. Our focus for the next
quarter is on collecting the funds from the
About liposomal ciprofloxacin
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF patients. The Company's once-a-day novel inhaled formulations of ciprofloxacin are encapsulated in liposomes, allowing for a sustained release of the drug within the lung and improving airway tolerability. The formulations are to be used for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. The Company previously reported positive results in Phase 2a studies of 22 CF patients and 36 BE patients who received ARD-3100 once-a-day for 2 (CF) or 4 (BE) weeks, respectively. A double-blind, placebo-controlled study in 96 bronchiectasis patients treated with ARD-3100 for 28 days (ORBIT-1) is currently underway. The Company is also developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia.
More information about
Except for the historical information contained herein, this news
release contains forward-looking statements, including, but not limited
to, statements regarding our future plans and expectations related to
clinical trials and potential partnerships. These forward-looking
statements involve risks and uncertainties that could cause actual
results to differ materially from those anticipated therein, including,
but not limited to, the ability to enter into partnerships, the costs,
timing and results of clinical trials, the risk that results of later
stage clinical trials may not be as favorable as earlier trials,
* Other names and brands may be claimed as the property of others.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three months ended
Nine months ended
|Research and development||2,403||2,426||7,976||9,079|
|General and administrative||895||1,323||3,530||4,089|
|Restructuring and asset impairment||11||1,638||37||1,860|
|Total operating expenses||3,309||5,387||11,543||15,028|
|Loss from operations||(3,070||)||(504||)||(7,304||)||(10,145||)|
|Other income (expense), net||15||1||121||(3||)|
|Gain from extinguishment of debt||4,462||-||4,462||-|
|Basic and diluted net income/(loss) per common share||$||0.01||$||(0.01||)||$||(0.03||)||$||(0.12||)|
|Shares used in computing basic net income/(loss) per common share||139,167||99,347||114,787||89,888|
|Shares used in computing diluted net income/(loss) per common share||140,177||99,347||114,787||89,888|
CONDENSED BALANCE SHEETS
|Cash and cash equivalents||$||7,367||$||3,903|
|Prepaid and other current assets||164||328|
|Total current assets||7,912||9,614|
|Property and equipment, net||1,693||2,166|
|LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)|
|Accrued clinical and cost of other studies||838||670|
|Facility lease exit obligation||141||263|
|Other accrued liabilities||395||357|
|Total current liabilities||2,111||2,203|
|Facility lease exit obligation, non-current||754||828|
|Other non-current liabilities||75||75|
|Note payable and accrued interest||-||8,896|
|Shareholders' equity (deficit)||6,744||(173||)|
|Total liabilities and shareholders' equity (deficit)||$||9,795||$||11,965|
* The balance sheet at
News Provided by Acquire Media