Full Press Release Details
Reports Second Quarter 2017 Financial Results, and Provides Operational
Phase III Trial with Voclosporin Has Been Initiated
$190 million as of June 30, 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--August 10, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the second quarter
ended June 30, 2017. Amounts, unless specified otherwise, are expressed
"Our Phase III clinical trial (AURORA) evaluating voclosporin for the
treatment of lupus nephritis is underway, and we are enrolling
patients," said Richard Glickman, Aurinia's CEO and Chairman of the
Board. "The clinical team continues to initiate sites around the globe
implementing an aggressive patient recruitment program. We are on track
to complete enrollment in eighteen months."
Operational highlights
On May 17, 2017, we announced that the first patient was dosed in
AURORA, the Company's Phase III confirmatory clinical trial evaluating
voclosporin for the treatment of lupus nephritis (LN).
On June 4, 2017 and June 14, 2017, we presented additional data from our
global Phase IIB AURA-LV (AURA) study in LN during the 54th European
Renal Association-European Dialysis and Transplant Association Congress
(ERA-EDTA) and the European Annual Congress of Rheumatology (EULAR 2017).
As previously reported, treatment with low dose voclosporin showed
statistically improved efficacy over the control arm at 24 and 48 weeks.
The data presented at ERA-EDTA demonstrated this improved efficacy was
attained while maintaining stable serum magnesium, potassium and blood
pressure levels. Well-known side effects with other calcineurin
inhibitors at their effective dose include hypomagnesemia and
hyperkalemia, which are associated with renal impairment and require
monitoring or intervention.
The data presented at EULAR 2017 demonstrated that over the course of
the 48-week trial, patients on voclosporin stayed in remission
approximately twice the amount of time as those in the control group.
Financial Results for the Second Quarter Ended June 30, 2017
Cash, cash equivalents and short term investments were $189.8 million as
at June 30, 2017 compared to $202.1 million as of March 31, 2017, and
$39.6 million as at December 31, 2016. We believe, based on our current
plans, that we have the financial resources to complete the AURORA trial
and the regulatory submission process.
For the three months ended June 30, 2017, we reported a consolidated net
loss of $2.4 million or $0.03 per common share. This loss included a
non-cash revaluation adjustment (gain) of $7.5 million related to the
estimated fair value quarterly adjustment of derivative warrant
liabilities at June 30, 2017. After adjusting for this non-cash impact,
the net loss before change in estimated fair value of derivative warrant
liabilities was $9.9 million.
This compared to a consolidated net loss of $3.3 million or $0.10 per
common share, which included a non-cash revaluation adjustment (gain) on
revaluation of derivative warrant liability of $1.4 million at June 30,
2016. After adjustment for the non-cash impact of the revaluation, the
net loss before change in estimated fair value of derivative warrant
liabilities for the three months ended June 30, 2016 was $4.6 million.
The change in the revaluation of the derivative warrant liabilities is
primarily driven by the change in our share price. Our share price
decreased at June 30, 2017 compared to March 31, 2017 which resulted in
a revaluation gain. These derivative warrant liabilities will ultimately
be transferred to equity upon the exercise or expiry of these warrants
and therefore are non-cash adjustments.
We incurred net research and development costs of $7.1 million for the
three months ended June 30, 2017, as compared to $2.4 million for the
same period in 2016. The increase in research and development costs for
the three months ended June 30, 2017 reflected AURORA trial commencement
costs, including activities such as clinical site initiations,
regulatory submissions, drug manufacturing and drug distribution.
We incurred corporate, administration and business development costs of
$2.9 million for the three months ended June 30, 2017, as compared with
$1.8 million for the same period in 2016. These costs included a
non-cash stock compensation expense of $718,000 for the three months
ended June 30, 2017 compared to $9,000 for the three months ended June
This press release should be read in conjunction with our unaudited
interim condensed consolidated financial statements and the MD&A for the
second quarter ended June 30, 2017 which are accessible on Aurinia's
website at www.auriniapharma.com, on SEDAR at www.sedar.com
or on EDGAR at www.sec.gov/edgar.
The AURORA trial is a 52-week global double-blind placebo controlled
phase III trial that will compare the efficacy of one dose of
voclosporin (23.7mg BID) or placebo added to current standard of care of
mycophenolate mofetil (MMF, also known as CellCept ) in achieving renal
response (formerly referred to as complete remission) in patients with
active LN. Both arms will also receive corticosteroids as part of
background therapy. These corticosteroids will be stringently and
aggressively tapered over the course of the trial.
The AURA-LV trial (Aurinia Urinary Protein Reduction in Active Lupus
with Voclosporin) was a 48-week trial comparing the efficacy of two
doses of voclosporin added to current standard of care of MMF against
standard of care with placebo in achieving CR in patients with active
LN. All arms also received low doses of corticosteroids as background
therapy. 265 patients were enrolled at centers in 20 countries
worldwide. On entry to the study, patients were required to have a
diagnosis of LN according to established diagnostic criteria (American
College of Rheumatology) and clinical and biopsy features indicative of
highly active nephritis. The 24-week primary and secondary endpoints
were released in Q3 2016 with top-line 48-week results announced in Q1
2017. The 48-week data was presented at a late-breaking presentation at
National Kidney Foundation (NKF) Spring Clinical Meeting which took
place April 18-22 in Orlando, FL.
Voclosporin, an investigational drug, is a novel and potentially
best-in-class calcineurin inhibitor ("CNI") with clinical data in over
2,200 patients across indications. Voclosporin is an immunosuppressant,
with a synergistic and dual mechanism of action that has the potential
to improve near- and long-term outcomes in LN when added to standard of