Mr. Richard Glickman reports
AURINIA REPORTS FIRST QUARTER FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
Aurinia Pharmaceuticals Inc. has released its financial results for the first quarter
ended March 31, 2018. All amounts, unless specified otherwise, are expressed
in U.S. dollars.
"Our first quarter has been characterized by diligently executing the company's
clinical programs. Our remain on track to complete recruitment for our
phase 3 trial in lupus nephritis later this year and are pleased with
the trial's progress. Start-up activities are under way for our FSGS (glomerulosclerosis) and
Dry Eye programs, and the company 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 chief executive officer and chairman of the board.
The company's phase 3 clinical trial (aurora) to evaluate voclosporin for
the treatment of lupus nephritis (LN), which the company initiated in May,
2017, is on track to complete enrolment in Q4 2018. The company has 212
clinical trial sites activated and the sites are able to enroll patients around the
A phase 2 proof-of-concept study in FSGS is expected to initiate in June, 2018. This
will be an open-label study of 20 treatment naive patients. The company
submitted its investigational new drug application (IND) to the FDA (Food and Drug Administration)
in Q1 2018. The company received agreement from the FDA with regard to the
guidance the company provided on this study, and the IND is now active.
The company also expects to initiate a phase 2a head-to-head tolerability study
of voclosporin ophthalmic solution (VOS) versus Restasis 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, the company reactivated its
existing IND and is aligned to proceed. The company believes 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.
Upon completion, the company will look to evaluate strategic alternatives for
The company strengthened the breadth and scope of its board of directors with
the additions of Dr. Michael Hayden and Joseph Hagan in February,
Financial liquidity at March 31, 2018
At March 31, 2018, the company had cash, cash equivalents and short-term
investments of $159.1-million as well as working capital of $156.7-million,
compared with $173.5-million of cash, cash equivalents and short-term
investments as well as $167.1-million of working capital at Dec. 31, 2017.
Net cash used in operating activities was $14.4-million for the first
quarter ended March 31, 2018, compared with $9.7-million for the first
quarter ended March 31, 2017.
The company believes, based on the company's current plans, that is has sufficient
financial resources to finance its existing LN program (including the
aurora trial and the NDA submission to the FDA), conduct the planned
phase 2 trials for FSGS and DES, and finance operations into 2020.
Financial results for the first quarter ended March 31, 2018
The company reported a consolidated net loss of $15.5-million, or 18 cents per common
share, for the first quarter ended March 31, 2018, as compared with a
consolidated net loss of $51.9-million, or 92 cents 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 with 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 the company's share prices
at March 31, 2018, and March 31, 2017, compared with Dec. 31, 2017, and
Dec. 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 with $11.2-million for the same period in
Research and development expenses increased to $8.9-million in
the first quarter of 2018, compared with $7.3-million in the first quarter
of 2017. The increase in these expenses resulted from higher clinical
patient enrolment and treatment costs for the company's aurora trial and costs
associated with the planning and start-up phase for the FSGS and DES
phase 2 trials, as well as the LN continuation study. Research and development expenses for the
first quarter ended March 31, 2017, included costs related to the aurora
planning phase and completion costs for the phase 2 trial.
Corporate, administration and business development expense also
increased to $3.8-million for the first quarter ended March 31, 2018,
compared with $3.4-million for the first quarter ended March 31, 2017,
primarily reflecting increased personnel costs due to the expansion of
the company's activities.
This press release should be read in conjunction with the company's 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,
on SEDAR or on EDGAR.
About Aurinia Pharmaceuticals Inc.
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 and DES. The company is headquartered in Victoria, B.C., and focuses its development efforts globally.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands of U.S. dollars, except per-share data)
Three months ended Three months ended
March 31, 2018 March 31, 2017
Licensing revenue $ 30 $ 30
Research and development 8,887 7,325
Corporate, administration and business development 3,791 3,427
Amortization of acquired intellectual property and
other intangible assets 396 357
Amortization of property and equipment 3 6
Other (income) expense (200) 75
Net (loss) before change in estimated fair value of
derivative warrant liabilities (12,847) (11,160)
Change in estimated fair value of derivative
warrant liabilities (2,631) (40,781)
Net (loss) and comprehensive (loss) for the period (15,478) (51,941)
Net (loss) per common share
Basic and diluted (loss) per common share (0.18) (0.92)
We seek Safe Harbor.
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