Full Press Release Details
Reports Third Quarter 2017 Financial Results and Provides Operational
Phase III Trial in lupus nephritis on track
FSGS, MCD and Dry Eye to begin in the first half of 2018
$182.4 million as of September 30, 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--November 14, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the third quarter
ended September 30, 2017. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
Operational highlights
On October 20, 2017 we announced plans to expand our renal franchise by
investigating voclosporin in focal segmental glomerulosclerosis (FSGS)
and minimal change disease (MCD). Additionally, we announced plans to
evaluate our proprietary nanomicellar voclosporin ophthalmic solution
(VOS) for the treatment of keratoconjunctivitis sicca or dry eye
syndrome (DES). The advancement of these new indications, in addition to
lupus nephritis (LN), represents an expansion of the company's strategy,
pipeline and commercial opportunities.
A Phase II proof of concept clinical trial for voclosporin in FSGS and
MCD patients will be initiated in the first half of 2018. FSGS and MCD
affect nearly 150,000 patients globally, accounting for almost 50% of
patients with Nephrotic Syndrome (NS). The prevalence of FSGS and MCD is
increasing through improved diagnosis, and it has been shown that the
control of proteinuria is important for long-term survival of these
patients. Interim data readouts are anticipated in the second half of
We also plan to begin a Phase IIa tolerability study of VOS versus the
standard of care for the treatment of DES by the second quarter of 2018,
with data available in the second half of 2018. Calcineurin inhibitors
(CNIs) are a mainstay in the treatment for DES, and the goal of this
program is to develop a best-in-class treatment option.
Our Phase III clinical trial (AURORA) for the treatment of LN is on
track to complete enrollment in the second half of 2018, with 138
clinical trial sites active around the globe. Additionally, under
voclosporin's fast-track designation, we intend to utilize a rolling New
Drug Application (NDA) process, with the first module being submitted in
the second half of 2018.
"With the AURORA trial in LN on track to complete enrollment in the
second half of 2018, we're thrilled to enter this exciting next phase of
development for Aurinia," said Richard Glickman, L.L.D., CEO and
Chairman of Aurinia Pharmaceuticals. "By expanding our renal franchise
and launching a development program in dry eye, we have the potential to
create significant value for shareholders."
Financial Results for the Third Quarter Ended September 30, 2017
Cash, cash equivalents and short term investments were $182.4 million as
at September 30, 2017 compared to $189.8 million as of June 30, 2017,
and $39.6 million as at December 31, 2016. We believe, based on our
current plans, that we have sufficient financial resources to fund our
existing LN program, including the AURORA trial, conduct work on the new
indications and fund operations into 2020.
For the three months ended September 30, 2017, we reported a
consolidated net loss of $13.1 million or $0.16 per common share
compared to a consolidated net loss of $7.4 million or $0.21 per common
share for the three months ended September 30, 2016.
We incurred research and development expenses of $10.8 million for the
three months ended September 30, 2017, as compared to $3.3 million for
the same period in 2016. The increase in research and development
expenses for the three months ended September 30, 2017 reflected AURORA
clinical expenses such as contract research organization (CRO) service
fees and pass thru costs for activities including site activations,
regulatory submissions, patient treatment and drug costs for manufacture
of voclosporin drug product, and drug encapsulation, packaging and
distribution for the trial.
We incurred corporate, administration and business development costs of
$2.6 million for the three months ended September 30, 2017, as compared
with $1.7 million for the same period in 2016. These costs included a
non-cash stock compensation expense of $795,000 for the three months
ended September 30, 2017 compared to $469,000 for the three months ended
This press release should be read in conjunction with our unaudited
interim condensed consolidated financial statements and the MD&A for the
third quarter ended September 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.
Aurinia is a clinical stage biopharmaceutical company focused on
developing and commercializing therapies to treat targeted patient
populations that are suffering from serious diseases with a high unmet
medical need. The company is currently developing voclosporin, an
investigational drug, for the treatment of LN, FSGS, MCD and DES. The
company is headquartered in Victoria, BC and focuses its development
About FSGS, MCD and NS
NS is a collection of symptoms that indicate kidney damage, including:
large amounts of protein in urine; low levels of albumin and higher than
normal fat and cholesterol levels in the blood, and edema. Similar to
LN, early clinical response and reduction of proteinuria is thought to
be critical to long-term kidney health. Aurinia is focused specifically
on FSGS, a lesion characterized by persistent scarring identified by
biopsy and proteinuria and on MCD, a kidney disease in which large
amounts of protein are lost in the urine. FSGS and MCD both are causes
of NS and characterized by high morbidity. Currently, there are no
approved therapies for FSGS and MCD in the United States and the
DES, or keratoconjunctivitis sicca, is a chronic disease in which a lack
of moisture and lubrication on the eye's surface results in irritation
and inflammation of the eye. DES is a multifactorial, heterogeneous
disease estimated to affect greater than 20 million people in the United
LN in an inflammation of the kidney caused by Systemic Lupus
Erythematosus (SLE) and represents a serious progression of SLE. SLE is
a chronic, complex and often disabling disorder and affects more than
500,000 people in the United States (mostly women). The disease is
highly heterogeneous, affecting a wide range of organs & tissue systems.
It is estimated that as many as 60 percent of all SLE patients will
develop clinical LN requiring treatment. Unlike SLE, LN has