Full Press Release Details
Reports Third Quarter Financial Results, Clinical Highlights and
Corporate Development
Phase III Trial in lupus nephritis completes enrollment ahead of
II data for the treatment of dry eye expected in January 2019
II FSGS Trial ongoing
M. Glickman announces his intention to retire as CEO next year, upon
identification and appointment of an appropriate successor
VICTORIA, British Columbia--(BUSINESS WIRE)--November 8, 2018--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") has released its financial results for the third quarter
ended September 30, 2018. Amounts, unless specified otherwise, are
expressed in U.S. dollars.
"We achieved a significant milestone in September with the completion of
enrollment for the AURORA Phase III trial ahead of schedule. Our target
enrollment of 324 patients was surpassed due to high patient demand with
358 LN patients randomized in sites across 27 countries." said Richard
M. Glickman, Aurinia's CEO and Chairman of the Board. "I continue to be
impressed by our clinical team which has delivered on our important
milestones, and to that end, I am pleased to announce enrollment for the
phase II dry eye trial will be completed in the next couple of days, and
we expect top-line data in January 2019."
Our Phase III clinical trial ("AURORA") to evaluate voclosporin for
the treatment of lupus nephritis ("LN"), which we initiated in May of
2017, completed enrollment in September 2018. We expect top-line data
to be available in late 2019.
A significant percentage of patients who have completed the AURORA
trial are rolling over into the AURORA 2 blinded extension study
("AURORA 2") from the AURORA Phase III clinical trial. The purpose of
AURORA 2 is to assess the long-term benefit/risk of voclosporin in
patients with LN; however, this study is not a requirement for
potential regulatory approval for voclosporin.
We 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, and full enrollment is anticipated imminently. This four-week
study of approximately 90 patients is expected to complete by the end
of 2018 with data available in January 2019. 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.
We also initiated a Phase II proof-of-concept study in focal segmental
glomerulosclerosis ("FSGS") in June 2018 and are currently in the
process of enrolling patients. This is an open-label study of 20
treatment na ve patients diagnosed with primary FSGS.
Corporate Development
Aurinia also announced today that Richard M. Glickman, the Company's
Chairman and Chief Executive Officer, intends to retire from his
position once a suitable replacement is identified and appointed. The
Board of Directors will retain a search firm and initiate a search for
"Richard is a gifted entrepreneur who has established Aurinia as a
leading biotech company and shepherded it to its next phase of growth.
On behalf of the Board of Directors, I want to thank him for his
inspired leadership and significant contribution to both the Company and
patient community since Aurinia's inception in 2012," said George M.
Milne Jr, Ph.D., Independent Director and Chairman of the Governance
Committee. "Under his direction, the Company has delivered on all its
key milestones and evolved into a patient-centric, late-stage clinical
company with investigational drugs addressing multiple indications
across the global immunology market."
"Two years ago - a critical time in the company's growth - my decision
to come out of retirement to join Aurinia as CEO was fueled by my
absolute belief in the potential for voclosporin to transform the lupus
nephritis treatment landscape," said Dr. Glickman. "I'm incredibly proud
of Aurinia's progress over the last 21 months, and I know this is the
optimal time to bring in a new CEO who will build on our clinical
success as we approach commercialization. My commitment to the Company
and the patients it serves is steadfast, and I plan to remain a resource
to the Board and management team as it enters its next chapter."
Financial Liquidity at September 30, 2018
At September 30, 2018, we had cash, cash equivalents and short term
investments of $138.9 million compared to $150.2 million at June 30,
2018 and $173.5 million at December 31, 2017. Net cash used in operating
activities was $11.3 million for the third quarter ended September 30,
2018 compared to $8.5 million for the third quarter ended September 30,
We believe that our cash position is sufficient to fund our existing LN
program including the AURORA clinical trial, conduct our current studies
in FSGS and DES, complete the work required for the NDA submission to
the FDA, and fund operations into 2020.
Financial Results for the Three and Nine Months Ended September 30,
We reported a consolidated net loss of $18.3 million or $0.21 per common
share for the three months ended September 30, 2018, as compared to a
consolidated net loss of $13.1 million or $0.16 per common share for the
three months ended September 30, 2017.
The increase in the loss for the three months ended September 30, 2018
compared to the same period in 2017 was primarily due to the non-cash
change of $5.2 million in the estimated fair value of derivative warrant
liabilities. The three months ended September 30, 2018 reflected a $4.8
million increase in the estimated fair value of derivative warrant
liabilities compared to a reduction of $355,000 in the estimated fair
value of derivative warrant liabilities for the three months ended
September 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 $13.5 million for the three months
ended September 30, 2018 compared to $13.5 million for the same period
For the nine months ended September 30, 2018, the consolidated net loss