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Aradigm Announces Fourth Quarter 2013 and Full Year Financial Results
Fourth Quarter 2013 Results
The Company recorded
Full Year Results
Revenues for the year ended
Total operating expenses for 2013 were
The net loss for the year ended
"2013 was a game changing year for
November 2013: we announced the appointment of Juergen Froehlich, M.D. as Chief Medical Officer. On November 9, 2013, the Company announced that it appointed Dr. Juergen Froehlichas Aradigm's Chief Medical Officer. He joins Aradigmfrom Vertex Pharmaceuticals where he was Head of Regulatory Affairs, overseeing submissions and approvals under accelerated review timelines of Kalydeco (ivacaftor) for the orphan indication of cystic fibrosis. Dr. Froehlich has more than 20 years of pharmaceutical industry experience in preclinical, clinical and regulatory activities at Boehringer Ingelheim, Genentech, Quintiles, Bristol-Myers Squibb, Ipsen and Vertex Pharmaceuticals. While at Genentech, Dr Froehlich directed the clinical development, submission and approval of Activase for acute ischemic stroke and the early development of Xolair for the treatment of allergic rhinitis and allergic asthma. At Bristol-Myers Squibb, Dr. Froehlich oversaw the global life cycle management for Plavix and Avapro. At Ipsen, he directed the FDAsubmission and approval for Somatuline for acromegaly, oversaw development Dysport for cervical dystonia as well as clinical studies and regulatory strategies for recombinant porcine factor VIII in hemophilia. Dr. Froehlich was closely involved in the commercialization of various drugs and biologics and alliance activities with other companies. Dr. Froehlich graduated from the Medical Schoolat Wuerzburg Universityin Germany. He is a Diplomate of the American Board of Clinical Pharmacology, a Fellow of the American College of Clinical Pharmacologyand a Fellow of the Faculty of Pharmaceutical Medicine. He also holds a dual executive MBA degree from the Graduate School of Business Administrationin Zurich, Switzerlandand from the State University of New York at Albany.
September 2013: we signed a manufacturing agreement with Sigma-Tau Pharmasource, Inc.("Sigma-Tau") for the clinical and commercial supply of Pulmaquin. Under the terms of the broad manufacturing services agreement, Sigma-Tau will manufacture the drug product Pulmaquin and placebo for Aradigm's Phase 3 clinical studies ORBIT-3 and ORBIT-4 in patients in non-cystic fibrosis bronchiectasis, and will support Aradigmin the preparation of its submissions to regulatory authorities in pursuit of marketing approval for the product. Subsequent to market approval, Sigma-Tau will produce the product commercially for patients using Pulmaquin.
August 2013: we completed the closing of the worldwide licensing transaction with Grifols, S.A. to develop and commercialize Pulmaquin: The transaction includes an exclusive, worldwide license for Aradigm's proprietary formulations of inhaled ciprofloxacin for the treatment of severe respiratory diseases, including non-cystic fibrosis bronchiectasis (BE). The parties have agreed to advance Pulmaquin into Phase 3 clinical trials in BE. Grifols will be responsible for all development and clinical expenses up to a maximum of $65 millionfor the BE indication. Aradigmis entitled to receive cash payments of up to $25 millionupon achievement of development milestones. Grifols is responsible for all commercialization activities and will pay Aradigmtiered royalties on worldwide sales of products utilizing Aradigm's proprietary inhaled ciprofloxacin formulations. Grifols was granted an option to license Aradigm's AERx® pulmonary drug delivery platform for use with another molecule. In conjunction with the licensing agreement, Grifols acquired 35% of Aradigm's common stock on a fully diluted basis at a price per share of $0.124for a total investment of approximately $26 million. Existing Aradigmshareholders, including Tavistock Life Sciences Companyand accounts managed by First Eagle Investment Management, LLC, and new investor Great Point Partners, LLCco-invested in the stock purchase transaction and purchased an additional approximately $15.4 millionin Aradigmcommon stock.
August 2013: we announced award of an NIH grant for PNTM. The National Institutes of Health(NIH) awarded the Company a Small Business Initiative Research(SBIR) grant in the amount of approximately $278,000to investigate the treatment of pulmonary non-tuberculous mycobacteria (PNTM) infections with Aradigm's inhaled liposomal ciprofloxacin products Pulmaquin and Lipoquin. The PNTM infection is chronic and it is an orphan condition with unmet medical need, often associated with cystic fibrosis and non-cystic fibrosis bronchiectasis. The research program is being conducted in collaboration with Oregon State University, Corvalis.
August 2013: we announced award of an NIH grant for new methods of diagnoses of aspirations of gastrointestinal contents into the respiratory tract. The NIH awarded the Company an SBIR grant in the amount of approximately $340,000to investigate the development and validation of tests for gastro-esophageal reflux with aspirations into the respiratory tract which is suspected to be the cause of the origin or worsening of a number of severe respiratory diseases. The research program is being conducted in collaboration with scientists at the University of California, San Francisco(UCSF). The funding is for laboratory work and a human clinical trial to be conducted at UCSF.
About inhaled ciprofloxacin (Pulmaquin and Lipoquin®)
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. Lipoquin is a liposomal formulation of ciprofloxacin. Pulmaquin is a dual release formulation that is a mixture of Lipoquin with unencapsulated ciprofloxacin.
Pulmaquin has been tested extensively in preclinical tests, as well as in the ORBIT-2 Phase 2b bronchiectasis study in which outstanding antimicrobial activity coupled with good safety and tolerability was found, and, most importantly, the positive impact on prevention of exacerbations compared to placebo was also observed. The Company is preparing to initiate two global, double-blind, placebo-controlled Phase 3 clinical trials in BE (ORBIT-3 and ORBIT-4) in the first half of 2014. The Company previously reported positive results in Phase 2a studies of 22 CF patients and 36 BE patients who received Lipoquin once-a-day for 2 (CF) or 4 (BE) weeks, respectively.
The Company was recently awarded an NIH grant to fund studies to
investigate the treatment of pulmonary non-tuberculous mycobacteria
(PNTM) infections with Aradigm's inhaled liposomal ciprofloxacin
products. Additionally, Aradigm's inhaled ciprofloxacin has been
successfully tested in animal models of the bioterrorism infections
inhalational tularemia, pneumonic plague and Q-fever.
More information about
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including statements regarding the conduct and completion
of clinical trials and the availability and sufficiency of financial
resources to complete those trials, as well as the other risks detailed
from time to time in the Company's filings with the
CONSOLIDATED STATEMENTS OF OPERATIONS
|(In thousands, except per share data)|
|Three months ended||Year ended|
|Research and development||3,884||1,477||8,884||3,781|
|General and administrative||974||887||4,775||3,896|
|Collaboration arrangement acquisition cost||-||
|Restructuring and asset impairment||6||8||27||34|
|Total operating expenses||4,864||2,372||29,629||7,711|
|Loss from operations||(226||)||(2,149||)||(19,912||)||(6,704||)|
|Other income (expense), net||(4||)||-||(9||)||(2||)|
|Change in unrealized gains (losses) on available-for-sale securities||-||-||-||(1||)|
|Basic and diluted net loss per common share||$||(0.00||)||$||(0.01||)||$||(0.06||)||$||(0.04||)|
|Shares used in computing basic and diluted net loss per common share||586,391||210,137||366,165||201,310|
|CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||48,131||$||7,414|
|Prepaid and other current assets||1,448||106|
|Total current assets||49,671||7,764|
|Property and equipment, net||400||727|
|LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)|
|Accrued clinical and cost of other studies||1,831||500|
|Facility lease exit obligation||168||144|
|Other accrued liabilities||82||127|
|Total current liabilities||7,277||1,285|
|Deferred rent, non-current||132||144|
|Facility lease exit obligation, non-current||297||465|
|Note payable and accrued interest||9,035||8,513|
|Shareholders' equity (deficit)||33,683||(1,441||)|
|Total liabilities and shareholders' equity (deficit)||$||50,424||$||8,966|
Chief Financial Officer
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