Full Press Release Details
Reports Third Quarter 2015 Financial Results
VICTORIA, British Columbia--(BUSINESS WIRE)--November 13, 2015--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the third quarter
ended September 30, 2015. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
Financial results for third quarter ended September 30, 2015
The Company's Phase 2b AURA-LV study continued to progress in the third
quarter of 2015 with activities focused on the recruitment, enrollment
and treatment of patients with lupus nephritis (LN). Over 90 sites are
set up in 20 countries worldwide. The Company anticipates completion of
patient enrollment around the end of 2015. Un-blinding and disclosure of
the primary trial data is scheduled within one month of the last
enrolled patient completing 24 weeks of active treatment.
The Company also continues to recruit patients into its AURION study
which is currently enrolling patients in sites in Malaysia. AURION is an
open label clinical study which will investigate the impact of
voclosporin on LN biomarkers with enrollment projected to be completed
The Company had cash, cash equivalents and short term investments of
$20.6 million at September 30, 2015 compared to $25.7 million at June
30, 2015 and $32.7 million at December 31, 2014. The Company believes
its cash position will be sufficient to finance its operational needs
until at least December 31, 2016. However, future cash requirements
could vary materially from current estimates due to a number of factors
including the timing and costs associated with its clinical trial and
potential strategic opportunities.
For the third quarter ended September 30, 2015, the Company reported a
consolidated net loss of $5.2 million or $0.16 per common share, as
compared to a restated consolidated net income of $2.8 million or $0.08
per fully diluted common share for the same period in 2014.
The change was primarily attributable to an increase of $2.2 million in
Phase 2b LN clinical trial costs and a decrease of $4.1 million in the
non-cash gain on the quarterly fair value revaluation of the derivative
warrant liability for the three months ended September 30, 2015 compared
to the same period in 2014. In addition the 2014 comparative figure
reflected a gain on extinguishment of warrant liability of $1.75
million. There was no similar item in 2015.
For the nine months ended September 30, 2015, the consolidated net loss
was $14.5 million or $0.45 per common share compared to a restated
consolidated net loss of $13.1 million or $0.46 per common share for the
comparable period in 2014.
After adjusting for the non-cash impact of the revaluation of the
warrant liability, the net losses from operations for the three and nine
month periods ended September 30, 2015 were $6.4 million and $18.2
million respectively compared to $2.5 million and $11.7 million for the
same periods in 2014.
Research and development expenses increased to $4.7 million for the
three months ended September 30, 2015, compared to $2.4 million for the
three months ended September 30, 2014. Research and development
expenditures in the third quarter of 2015 reflected higher costs related
to drug distribution, patient recruitment, enrollment and treatment
activities associated with the Company's Phase 2b LN clinical trial
compared to the same period in 2014. The Company incurred net research
and development expenditures of $12.3 million for the nine months ended
September 30, 2015, as compared to $6.0 million for the same period in
Corporate, administration and business development expenses were
consistent at $1.4 million for the three months ended September 30, 2015
and September 30, 2014. These expenses included a non-cash stock
compensation expense of $539,000 for the three months ended September
30, 2015 compared to $286,000 for the same period in 2014. The Company
incurred corporate, administration and business development expenses of
$4.7 million for the nine months ended September 30, 2015 compared to
$5.5 million for the same period in 2014 and included non-cash stock
compensation expense of $2.0 million for the nine months ended September
30, 2015 compared to $1.8 million for the comparable period in 2014.
The unaudited interim condensed consolidated financial statements and
the MD&A for the third quarter ended September 30, 2015 are accessible
on Aurinia's website at www.auriniapharma.com or on SEDAR at www.sedar.com
or on EDGAR at www.sec.gov/edgar.
Aurinia is a clinical stage pharmaceutical company focused on the global
nephrology market. It is currently enrolling patients in its Phase 2b
clinical trial to evaluate the efficacy of its drug, voclosporin, as a
treatment for LN. LN is an inflammation of the kidneys, that if
inadequately treated can lead to end-stage renal disease, making LN a
serious and potentially life-threatening condition.
Voclosporin is a novel and potentially best in class calcineurin
inhibitor ("CNI") with extensive clinical data in over 2,000 patients in
other indications. Voclosporin is made by a modification of a single
amino acid of the cyclosporine molecule (a CNI approved for use in
transplant patients since 1983). This modification results in a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency vs. cyclosporine, an altered metabolic profile, and
potential for flat dosing.
The AURA-LV study or "Aurinia Urine Protein Reduction in Active Lupus
Nephritis Study" is an adequate and well controlled clinical trial that
is being conducted in 20 countries worldwide and is expected to enrol
approximately 258 patients which will compare the efficacy of
voclosporin against placebo in achieving remission in patients with
active lupus nephritis. The AURA-LV study is designed to demonstrate
that voclosporin can induce a rapid and sustained reduction of
proteinuria in the presence of extremely low steroid exposure and to
fulfill specific regulatory requests. It will compare two dosage groups
of voclosporin (23.7mg and 39.5mg) administered with mycophenolate
mofetil (MMF) vs. MMF alone. All patients will also receive oral
corticosteroids as background therapy. There will be a primary analysis
to determine complete remission at week 24 and various secondary
analyses at week 48 which include biomarkers and markers of non-renal
The AURION study or "Aurinia Early Urinary Protein Reduction Predicts
Response Study" is an open label, exploratory study being conducted in
multiple sites in Malaysia to assess the short term predictors of