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Aradigm Announces Fourth Quarter 2011 and Full Year Financial Results
The Company recorded
Full Year Results
Revenues for the year ended
Total operating expenses for 2011 were
The net loss for the year ended
2011 and Recent Highlights
March 2012: received clearance from the FDAfor BE IND. On March 12, 2012, the Company announced that its Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of Pulmaquin (dual release ciprofloxacin for inhalation) in non-cystic fibrosis bronchiectasis (BE) was cleared by the U.S. Food and Drug Administration(FDA).
February 2012and December 2011: patents issued for Pulmaquin. On February 21, 2012, the Company announced that the United States Patent and Trademark Office (USPTO) issued an important composition of matter patent covering formulations of liposomal and free ciprofloxacin, including its lead product candidate, Pulmaquin. The Company expects that the patent will provide exclusivity for Pulmaquin until October 22, 2028. On December 7, 2011, the Company announced that the USPTO issued a method of treatment patent for Pulmaquin.
July 2011: closed the private placement raising $4.75 millionin aggregate proceeds. On July 6, 2011, the Company announced that it entered into a definitive agreement for the sale of common stock to three existing shareholders, including accounts managed by First Eagle Investment Management LLCand Tavistock Life Sciences, in a private placement for aggregate gross proceeds of $4.75 million. Under the terms of the agreement, the Company agreed to sell an aggregate of 25,000,000 shares of common stock at a price of $0.19per share. After deducting for fees and expenses, the net proceeds from the sale of the shares of common stock were approximately $4.4 million.
June 2011: closed the royalty financing transaction raising $8.5 millionin aggregate proceeds. On June 22, 2011, the Company announced that it entered into an $8.5 millionroyalty financing agreement with a syndicate of lenders arranged by PBS Capital Management LLC. The agreement created a debt obligation that will be repaid through and secured by royalties from net sales of the SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system payable to Aradigmunder its Asset Purchase Agreement ("APA") with Zogenix, Inc. The APA provides for Aradigmto receive a 3% royalty on net sales of SUMAVEL DosePro in all territories. Under the terms of the royalty financing agreement, the Company received a loan of $8.5 million, less fees and expenses (approximately $473,000) and an additional $250,000set aside for an Interest Reserve Account. The lenders are entitled to receive 100% of all royalties payable to Aradigmunder the APA until the principal and accrued interest of the Term Loan are fully repaid, after which time the benefit of any further royalties made under the APA will accrue to Aradigm.
June 2011: announced positive top line data from the ORBIT-1 study. On June 16, 2011, the Company announced positive top line data from its multi-center Phase 2b study (Once-Daily Respiratory Bronchiectasis Inhalation Treatment - ORBIT-1) with Lipoquin (ciprofloxacin for inhalation, ARD-3100) in patients with BE. The primary endpoint - the mean change in Pseudomonas aeruginosa colony forming units per gram of sputum (CFUs) from baseline to day 28 — was met in the full analysis population.
June 2011: announced receipt of FDAorphan drug status for ciprofloxacin for inhalation for BE. On June 6, 2011, the Company announced it received orphan drug designation from the FDAfor ciprofloxacin for inhalation for the management of BE. Previously, the Company received orphan drug designations from the FDAfor liposomal ciprofloxacin for inhalation for the management of BE and for liposomal ciprofloxacin for the management of cystic fibrosis. Orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States. As a designated orphan drug, the Company's ciprofloxacin drug candidates are eligible for tax credits based upon their clinical development costs, as well as assistance from the FDAin guiding the drug candidates through the regulatory approval process. The designation also provides the opportunity to obtain market exclusivity for seven years from the date of NDA approval even in the absence of patent protection.
"In the last year, we completed several important transactions,
including the royalty financing transaction and the
More information about
Pulmaquin (ARD-3150) is a once-a-day novel inhaled formulation
consisting of a proprietary mixture of unencapsulated ciprofloxacin and
ciprofloxacin encapsulated in liposomes (Lipoquin), allowing for both
immediate and sustained release of the drug within the lung.
Ciprofloxacin is a widely prescribed antibiotic to treat infections of
the lung frequently experienced by 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 BE patients. Pulmaquin is to be used for chronic
maintenance therapy as it is expected to achieve higher antibiotic
concentration at the site of infection and relatively low systemic
antibiotic concentrations to minimize side-effects. The ORBIT-2 Phase 2b
study with Pulmaquin demonstrated positive results with outstanding
antimicrobial activity and a significant impact on the prevention of
pulmonary exacerbations. The Phase 3 clinical program for BE will
consist of two identical placebo controlled trials enrolling
approximately 250 patients per trial with one year duration and a design
similar to the ORBIT-2 trial.
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the timing and results of clinical trials and
continued receipt of royalties from Zogenix, Inc., as well as the other
risks detailed from time to time in the Company's filings with the
Other names and brands may be claimed as the property of others.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three months ended
|Research and development||651||2,234||5,007||10,210|
|General and administrative||679||955||4,274||4,485|
|Restructuring and asset impairment||9||11||39||48|
|Total operating expenses||1,339||3,200||9,320||14,743|
|Loss from operations||(1,156||)||(3,056||)||(8,529||)||(10,360||)|
|Other income (expense), net||2||723||4||844|
|Gain (loss) from extinguishment of debt||-||(27||)||-||4,435|
|Basic and diluted net loss per common share||$||(0.01||)||$||(0.01||)||$||(0.05||)||$||(0.04||)|
|Shares used in computing basic and diluted net loss per common share||197,833||169,824||183,419||128,660|
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||2,148||$||5,295|
|Prepaid and other current assets||161||180|
|Total current assets||8,861||5,906|
|Property and equipment, net||1,113||1,553|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accrued clinical and cost of other studies||247||993|
|Facility lease exit obligation||120||99|
|Other accrued liabilities||86||450|
|Total current liabilities||844||2,126|
|Deferred rent, non-current||132||99|
|Facility lease exit obligation, non-current||609||729|
|Other non-current liabilities||75||75|
|Note payable and accrued interest||8,207||-|
|Total liabilities and shareholders' equity||$||10,556||$||7,628|
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