Full Press Release Details
Reports Second Quarter Financial Results and Operational Highlights
Phase III Trial in lupus nephritis anticipated to complete enrollment
FSGS and Dry Eye initiated
VICTORIA, British Columbia--(BUSINESS WIRE)--August 9, 2018--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the second quarter
ended June 30, 2018. Amounts, unless specified otherwise, are expressed
"We are excited to announce that the AURORA Phase III trial in lupus
nephritis is running ahead of schedule and we now anticipate completing
enrollment in early Q4 2018. We are extremely pleased with the trial's
progress thus far and having patients roll over into the AURORA 2
extension study reinforces our confidence in the program", said Richard
Glickman, Aurinia's CEO and Chairman of the Board. "Our clinical team
continues to deliver on our important milestones with the Phase II
trials in FSGS and Dry Eye now initiated. We are well-capitalized into
2020 and look forward to an eventful second half of the year."
Our Phase III clinical trial ("AURORA") to evaluate voclosporin for
the treatment of lupus nephritis ("LN"), which we initiated in May of
2017, is now expected to complete enrollment in early Q4 2018. We have
over 225 clinical trial sites activated and able to enroll patients in
29 countries around the globe.
The first patients have rolled over into the AURORA 2 blinded
extension study from the AURORA Phase III clinical trial. The purpose
of AURORA 2 is to assess the long-term safety and tolerability of
voclosporin in patients with LN; however, this study is not a
requirement for potential regulatory approval for voclosporin.
We initiated a Phase II proof-of-concept study in focal segmental
glomerulosclerosis ("FSGS") in June 2018. This is an open-label study
of 20 treatment na ve patients. We submitted our Investigational New
Drug application ("IND") to the FDA in Q1 2018 and received agreement
from the FDA with regards to the guidance we provided on this study.
We also initiated a Phase II head-to-head tolerability study of
voclosporin ophthalmic solution ("VOS") versus Restasis (cyclosporine
ophthalmic emulsion) 0.05% for the treatment of Dry Eye Syndrome
("DES") in July 2018. Depending on the pace of recruitment, data could
be available as early as the end of this year or early 2019. This
four-week study of approximately 90 patients is expected to be
completed by the end of 2018. We believe calcineurin inhibitors
("CNIs") are a mainstay of treatment for DES, and the goal of this
program is to develop a best-in-class treatment option, and upon
completion, we will look to evaluate strategic alternatives for this
Financial Liquidity at June 30, 2018
At June 30, 2018, we had cash, cash equivalents and short term
investments of $150.2 million compared to $159.1 million at March 31,
2018 and $173.5 million at December 31, 2017. Net cash used in operating
activities was $12.3 million for the second quarter ended June 30, 2018
compared to $14.0 million for the second quarter ended June 30, 2017.
We believe, based on our current plans, that we have sufficient
financial resources to fund our existing LN program, including the
AURORA trial and the NDA submission to the FDA, conduct the Phase II
trials for FSGS and DES, and fund operations into 2020.
Financial Results for the Three and Six Months Ended June 30, 2018
We reported a consolidated net loss of $15.7 million or $0.19 per common
share for the three months ended June 30, 2018, as compared to a
consolidated net loss of $2.4 million or $0.03 per common share for the
three months ended June 30, 2017.
The increase in the loss for the three months ended June 30, 2018
compared to the same period in 2017 was primarily due to the non-cash
change in the estimated fair value of derivative warrant liabilities of
$9.4 million. The three months ended June 30, 2018 reflected a $1.9
million increase in the estimated fair value of derivative warrant
liabilities compared to a reduction of $7.5 million in the estimated
fair value of derivative warrant liabilities for the three months ended
June 30, 2017. The change in the revaluation of the derivative warrant
liabilities is primarily driven by the change in our share price at each
period end. An increase in our share price results in an increase in the
estimated fair value of derivative warrant liabilities and vice versa.
The derivative warrant liabilities will ultimately be eliminated on the
exercise or forfeiture of the warrants and will not result in any cash
outlay by the Company.
The net loss before the non-cash change in estimated fair value of
derivative warrant liabilities was $13.8 million for the three months
ended June 30, 2018 compared to $9.9 million for the same period in 2017
with the increased loss amount primarily reflecting higher research and
development expenses.
For the six months ended June 30, 2018, the consolidated net loss was
$31.2 million or $0.37 per common share compared to a consolidated net
loss of $54.3 million or $0.78 per common share for the comparable
period in 2017. For the six months ended June 30, 2018 we recorded an
increase of $4.6 million in the estimated fair value of derivative
warrant liabilities compared to $33.3 million for the comparable period
The net loss before the non-cash change in estimated fair value of
derivative warrant liabilities was $26.6 million for the six months
ended June 30, 2018 compared to $21.1 million for the same period in
2017. The increased loss reflected higher research and development
Research and development expenses increased to $10.5 million for the
three months ended June 30, 2018, compared to $7.1 million for the three
months ended June 30, 2017. We incurred research and development
expenses of $19.4 million for the six months ended June 30, 2018, as
compared to $14.4 million for the same period in 2017. The increased
research and development expenses reflected higher AURORA clinical and
drug supply costs as well as startup costs for the AURORA 2 extension
study, and the FSGS and DES studies.
Corporate, administration and business development expenses increased to
$3.5 million for the three months ended June 30, 2018, compared to $2.9
million for the same period in 2017. We incurred corporate,
administration and business development expenses of $7.3 million for the
six months ended June 30, 2018 compared to $6.3 million for the
comparable period in 2017. The increase was primarily due to higher
non-cash stock compensation expense in 2018 compared to the same periods