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Aradigm Announces Fourth Quarter 2014 and Full Year Financial Results
Fourth Quarter 2014 Results
The Company recorded
Full Year Results
Revenues for the year ended
Total operating expenses for 2014 were
The net income for the year ended
"2014 was a game-changing year for
March 2014- The Company announced the completion of the royalty assignment which eliminated all debt. The Company executed an Assignment Agreement that transferred the rights for all future royalty payments payable on sales of Zogenix, Inc.'s Sumavel DosePro to the royalty financing lenders, effective February 28, 2014, in full and complete satisfaction of the Company's obligations under the loan agreement entered into in connection with the royalty financing.
April 2014- The Company announced the first results from the collaboration between scientists from the Oregon State University, Corvallis (OSU) and Aradigmfunded by NIH for research in Non-Tuberculous Mycobacteria (NTM). The research demonstrated that after 4 days of in vitro treatment of human macrophages infected with Mycobacterium avium and Mycobacterium abscessus, Aradigm's liposomal ciprofloxacin was associated with a decrease of greater than 99% of these infections at ciprofloxacin concentrations of 200 mcg/ml, which approximate the peak sputum levels observed in humans in prior Aradigmclinical studies. At a lower concentration of 20 mcg/ml, the liposomal concentrations still showed statistically significant decreases greater than 70% for M. avium and greater than 90% for M. abscessus. Unencapsulated ciprofloxacin showed smaller decreases which were only statistically significant at 200 mcg/ml. Liposomal ciprofloxacin at a concentration of 100 mcg/ml significantly reduced the population of these mycobacteria in a biofilm assay by more than 50% whereas unencapsulated ciprofloxacin did not show statistically significant decreases.
April 2014- The Company announced the dosing of the first patient in the ORBIT-3 Phase III pivotal clinical trial. ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) is the first of the two Phase III pivotal clinical trials Aradigmis conducting with Pulmaquin in non-cystic fibrosis bronchiectasis (non-CF BE).
May 2014- U.S. Food and Drug Administration(FDA) designated the Company's lead inhaled antibiotic candidate, Pulmaquin, as a Qualified Infectious Disease Product (QIDP). The QIDP designation, granted for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa, will make Pulmaquin eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status.
June 2014- The Company received the $5 millionmilestone payment from Grifols S.A. for enrolling and dosing of the first patient in the ORBIT-3 Phase III pivotal clinical trial of Pulmaquin for the treatment of non-CF BE.
June 2014- Aradigmcommon shares began trading on the NASDAQ Capital Marketunder the ticker symbol "ARDM."
June 2014- The Company announced the dosing of the first patient in the ORBIT-4 Phase III pivotal clinical trial. ORBIT-4 is the second of the two Phase III pivotal clinical trials Aradigmis conducting with Pulmaquin in non-CF BE.
September 2014- The Company announced that the FDAgranted Fast Track designation to Pulmaquin. The FDAgives Fast Track status to facilitate the development of new drugs intended to treat serious or life-threatening conditions and which demonstrate the potential to address unmet medical needs, with the goal of getting important new drugs to patients earlier.
Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas aeruginosa. Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. It is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of non-cystic fibrosis bronchiectasis (non-CF BE).
Pulmaquin has been tested in preclinical safety studies (up to 3 months in rodents and 9 months in dogs).
Following Phase 2a development of the liposomal portion of Pulmaquin (Lipoquin®)and phase 1 development of Pulmaquin, the phase 2b study ORBIT-2 with Pulmaquin was a 24-week multicenter, randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE subjects. This study demonstrated a significant reduction in P.aeruginosa sputum activity (p=0.002) and a decrease in time to first exacerbation in the per protocol population (p=0.046) and the mITT (p=0.057) populations in the Pulmaquin treated subjects compared to placebo. Overall, the incidence of all treatment emergent adverse events was similar between groups. The most frequently reported treatment related adverse events (reported by ≥ 3 patients in either treatment group) included product taste abnormal and nausea in the Pulmaquin group and wheezing in the placebo group. No serious adverse events were considered treatment related. There were no deaths reported during ORBIT-2.
The Phase 3 clinical program for Pulmaquin in non-CF BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial is enrolling approximately 255 patients into a 48 week double-blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double-blind period is being evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator.
About Non-Cystic Fibrosis Bronchiectasis
Non-CF BE is a severe, chronic and rare disease characterized by
abnormal dilatation of the bronchi and bronchioles, frequently
associated with chronic lung infections. It is often a consequence of a
vicious cycle of inflammation, recurrent lung infections, and bronchial
wall damage. Non-CF BE represents an unmet medical need with high
morbidity and mortality that affects more than 110,000 people in the
U.S. and over 200,000 people in
More information about
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including those related to the ORBIT-3 and ORBIT-4
clinical trials and the ability to continue successful product
development of our potential product candidates, including Pulmaquin, 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|
|Contract revenue - related party||$||8,050||$||4,391||$||33,038||$||8,672|
|Research and development||7,673||3,884||31,172||8,884|
|General and administrative||1,201||974||6,226||4,775|
|Collaboration arrangement acquisition cost||-||-||-||15,943|
|Restructuring and asset impairment||4||6||19||27|
|Total operating expenses||8,878||4,864||37,417||29,629|
|Loss from operations||(810||)||(226||)||(3,856||)||(19,912||)|
|Other expense, net||(30||)||(4||)||(85||)||(9||)|
|Gain on assignment of royalty interests||-||5,823||-|
|Gain from extinguishment of debt||-||3,041||-|
Net income (loss) and comprehensive income (loss)
Basic net income (loss) per common share
Diluted net income (loss) per common share
Shares used in computing basic net income (loss) per common share
Shares used in computing diluted net income (loss) per common share
CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||47,990||$||48,131|
|Prepaid and other current assets||1,207||1,448|
|Total current assets||50,505||49,671|
|Property and equipment, net||502||400|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Accrued clinical and cost of other studies||2,070||1,831|
|Facility lease exit obligation||193||168|
|Other accrued liabilities||191||82|
|Total current liabilities||6,769||7,277|
|Accrued clinical and cost of other studies, non-current||33||-|
|Deferred rent, non-current||97||132|
|Facility lease exit obligation, non-current||104||297|
|Deferred revenue, non-current||7,845||-|
|Note payable and accrued interest||-||9,035|
|Total liabilities and shareholders' equity||$||53,963||$||50,424|
Chief Financial Officer
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