Full Press Release Details
Reports First Quarter Financial Results and Operational Highlights
Phase III Trial in lupus nephritis remains on track
FSGS and Dry Eye expected to begin in June 2018
VICTORIA, British Columbia--(BUSINESS WIRE)--May 10, 2018--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the first quarter
ended March 31, 2018. Amounts, unless specified otherwise, are expressed
"Our first quarter has been characterized by diligently executing our
clinical programs. We remain on track to complete recruitment for our
Phase III trial in lupus nephritis later this year and are pleased with
the trial's progress. Start-up activities are underway for our FSGS and
Dry Eye programs, and we expect to commence these in June. We continue
to be well-capitalized into 2020 and look forward to a productive 2018,"
said Richard Glickman, Aurinia CEO and Chairman of the Board.
Our Phase III clinical trial ("AURORA") to evaluate voclosporin for
the treatment of lupus nephritis ("LN"), which we initiated in May of
2017, is on track to complete enrollment in Q4 2018. We have 212
clinical trial sites activated and able to enroll patients around the
A Phase II proof-of-concept study in focal segmental
glomerulosclerosis ("FSGS") is expected to initiate in June 2018. This
will be an open-label study of 20 treatment na ve patients. We
submitted our Investigational New Drug application ("IND") to the FDA
in Q1 2018. We received agreement from the FDA with regards to the
guidance we provided on this study, and the IND is now active.
We also expect to initiate a Phase IIa 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 June 2018, with data expected to be available by
the end of 2018. This will be a four-week study of approximately 90
patients. Upon productive meetings with the FDA, we re-activated our
existing IND and are aligned to proceed. 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
We strengthened the breadth and scope of our Board of Directors with
the additions of Dr. Michael Hayden and Joseph Hagan in February of
Financial Liquidity at March 31, 2018
At March 31, 2018, we had cash, cash equivalents and short term
investments of $159.1 million and working capital of $156.7 million
compared to $173.5 million of cash, cash equivalents and short term
investments and $167.1 million of working capital at December 31, 2017.
Net cash used in operating activities was $14.4 million for the first
quarter ended March 31, 2018 compared to $9.7 million for the first
quarter ended March 31, 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 planned
Phase II trials for FSGS and DES, and fund operations into 2020.
Financial Results for the First Quarter ended March 31, 2018
We reported a consolidated net loss of $15.5 million or $0.18 per common
share for the first quarter ended March 31, 2018, as compared to a
consolidated net loss of $51.9 million or $0.92 per common share for the
first quarter ended March 31, 2017.
The loss for the first quarter ended March 31, 2018 reflected a $2.6
million increase in the estimated fair value of derivative warrant
liabilities compared to an increase of $40.8 million in the estimated
fair value of derivative warrant liabilities for the first quarter ended
March 31, 2017. An increase in estimated fair value of derivative
warrant liabilities increases the loss recorded for the period.
The increases in the estimated fair value of derivative warrant
liabilities were primarily the result of increases in our share prices
at March 31, 2018 and March 31, 2017 compared to December 31, 2017 and
December 31, 2016 respectively.
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 these non-cash changes in estimated fair value of
derivative warrant liabilities was $12.8 million for the first quarter
ended March 31, 2018 compared to $11.2 million for the same period in
Research and development ("R&D") expenses increased to $8.9 million in
the first quarter of 2018, compared to $7.3 million in the first quarter
of 2017. The increase in these expenses resulted from higher clinical
patient enrollment and treatment costs for our AURORA trial and costs
associated with the planning and start-up phase for the FSGS and DES
Phase II trials, and the LN continuation study. R&D expenses for the
first quarter ended March 31, 2017 included costs related to the AURORA
planning phase and completion costs for the Phase II AURA trial.
Corporate, administration and business development expense also
increased to $3.8 million for the first quarter ended March 31,2018,
compared to $3.4 million for the first quarter ended March 31, 2017,
primarily reflecting increased personnel costs due to the expansion of
This press release should be read in conjunction with our unaudited
interim condensed consolidated financial statements and the Management's
Discussion and Analysis for the first quarter ended March 31, 2018 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 potential treatment of LN,
FSGS and DES. The Company is headquartered in Victoria, BC and focuses
its development efforts globally.
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. The disease is highly heterogeneous, affecting a wide range of
organs & tissue systems. Unlike SLE, LN has straightforward disease
outcomes (measuring proteinuria) where an early response correlates with
long-term outcomes. In patients with LN, renal damage results in