AURORA Phase III Trial with Voclosporin Has
Been Initiated
Cash of $190 million as of June 30,
2017
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”) has released its financial results for the second
quarter ended June 30, 2017. Amounts, unless specified otherwise,
are expressed in U.S. dollars.
“Our Phase III clinical trial (AURORA) evaluating voclosporin
for the treatment of lupus nephritis is underway, and we are
enrolling patients," said Richard Glickman, Aurinia’s CEO and
Chairman of the Board. “The clinical team continues to initiate
sites around the globe implementing an aggressive patient
recruitment program. We are on track to complete enrollment in
eighteen months.”
Operational highlights
On May 17, 2017, we announced that the first patient was dosed
in AURORA, the Company’s Phase III confirmatory clinical trial
evaluating voclosporin for the treatment of lupus nephritis
(LN).
On June 4, 2017 and June 14, 2017, we presented additional data
from our global Phase IIB AURA-LV (AURA) study in LN during the
54th European Renal Association-European Dialysis and Transplant
Association Congress (ERA-EDTA) and the European Annual Congress of
Rheumatology (EULAR 2017).
As previously reported, treatment with low dose voclosporin
showed statistically improved efficacy over the control arm at 24
and 48 weeks. The data presented at ERA-EDTA demonstrated this
improved efficacy was attained while maintaining stable serum
magnesium, potassium and blood pressure levels. Well-known side
effects with other calcineurin inhibitors at their effective dose
include hypomagnesemia and hyperkalemia, which are associated with
renal impairment and require monitoring or intervention.
The data presented at EULAR 2017 demonstrated that over the
course of the 48-week trial, patients on voclosporin stayed in
remission approximately twice the amount of time as those in the
control group.
Financial Results for the Second Quarter Ended June 30,
2017
Cash, cash equivalents and short term investments were $189.8
million as at June 30, 2017 compared to $202.1 million as of March
31, 2017, and $39.6 million as at December 31, 2016. We believe,
based on our current plans, that we have the financial resources to
complete the AURORA trial and the regulatory submission
process.
For the three months ended June 30, 2017, we reported a
consolidated net loss of $2.4 million or $0.03 per common share.
This loss included a non-cash revaluation adjustment (gain) of $7.5
million related to the estimated fair value quarterly adjustment of
derivative warrant liabilities at June 30, 2017. After adjusting
for this non-cash impact, the net loss before change in estimated
fair value of derivative warrant liabilities was $9.9 million.
This compared to a consolidated net loss of $3.3 million or
$0.10 per common share, which included a non-cash revaluation
adjustment (gain) on revaluation of derivative warrant liability of
$1.4 million at June 30, 2016. After adjustment for the non-cash
impact of the revaluation, the net loss before change in estimated
fair value of derivative warrant liabilities for the three months
ended June 30, 2016 was $4.6 million.
The change in the revaluation of the derivative warrant
liabilities is primarily driven by the change in our share price.
Our share price decreased at June 30, 2017 compared to March 31,
2017 which resulted in a revaluation gain. These derivative warrant
liabilities will ultimately be transferred to equity upon the
exercise or expiry of these warrants and therefore are non-cash
adjustments.
We incurred net research and development costs of $7.1 million
for the three months ended June 30, 2017, as compared to $2.4
million for the same period in 2016. The increase in research and
development costs for the three months ended June 30, 2017
reflected AURORA trial commencement costs, including activities
such as clinical site initiations, regulatory submissions, drug
manufacturing and drug distribution.
We incurred corporate, administration and business development
costs of $2.9 million for the three months ended June 30, 2017, as
compared with $1.8 million for the same period in 2016. These costs
included a non-cash stock compensation expense of $718,000 for the
three months ended June 30, 2017 compared to $9,000 for the three
months ended June 30, 2016.
This press release should be read in conjunction with our
unaudited interim condensed consolidated financial statements and
the MD&A for the second quarter ended June 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.
About AURORA
The AURORA trial is a 52-week global double-blind placebo
controlled phase III trial that will compare the efficacy of one
dose of voclosporin (23.7mg BID) or placebo added to current
standard of care of mycophenolate mofetil (MMF, also known as
CellCept®) in achieving renal response (formerly referred to as
complete remission) in patients with active LN. Both arms will also
receive corticosteroids as part of background therapy. These
corticosteroids will be stringently and aggressively tapered over
the course of the trial.
About AURA-LV
The AURA–LV trial (Aurinia Urinary Protein Reduction in Active
Lupus with Voclosporin) was a 48-week trial comparing the efficacy
of two doses of voclosporin added to current standard of care of
MMF against standard of care with placebo in achieving CR in
patients with active LN. All arms also received low doses of
corticosteroids as background therapy. 265 patients were enrolled
at centers in 20 countries worldwide. On entry to the study,
patients were required to have a diagnosis of LN according to
established diagnostic criteria (American College of Rheumatology)
and clinical and biopsy features indicative of highly active
nephritis. The 24-week primary and secondary endpoints were
released in Q3 2016 with top-line 48-week results announced in Q1
2017. The 48-week data was presented at a late-breaking
presentation at National Kidney Foundation (NKF) Spring Clinical
Meeting which took place April 18-22 in Orlando, FL.
About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially
best-in-class calcineurin inhibitor (“CNI”) with clinical data in
over 2,200 patients across indications. Voclosporin is an
immunosuppressant, with a synergistic and dual mechanism of action
that has the potential to improve near- and long-term outcomes in
LN when added to standard of care (MMF). By inhibiting calcineurin,
voclosporin blocks IL-2 expression and T-cell mediated immune
responses. It is made by a modification of a single amino acid of
the cyclosporine molecule which has shown a more predictable
pharmacokinetic and pharmacodynamic relationship, an increase in
potency, an altered metabolic profile, and potential for flat
dosing. The Company anticipates that upon regulatory approval,
patent protection for voclosporin will be extended in the United
States and certain other major markets, including Europe and Japan,
until at least October 2027 under the Hatch-Waxman Act and
comparable laws in other countries.
About Lupus Nephritis (LN)
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% of all
SLE patients have clinical LN requiring treatment. Unlike SLE, LN
has straightforward disease outcomes where an early response
correlates with long-term outcomes, measured by proteinuria. In
patients with LN, renal damage results in proteinuria and/or
hematuria and a decrease in renal function as evidenced by reduced
estimated glomerular filtration rate (eGFR), and increased serum
creatinine levels. LN is debilitating and costly and if poorly
controlled, LN can lead to permanent and irreversible tissue damage
within the kidney, resulting in end-stage renal disease (“ESRD”),
thus making LN a serious and potentially life-threatening
condition.
About Aurinia
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. The
Company is headquartered in Victoria, BC and focuses its
development efforts globally.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements around our analysis, assessment and
conclusions around the future development and commercial potential
of voclosporin; our belief that we have fully funded operations to
at least completion of the AURORA Phase III clinical trial and the
regulatory submission process; our belief that our prior clinical
trial results will serve as the basis for a NDA submission and
regulatory submissions in major global markets; and the timing of
future clinical trials; summary statements relating to results of
the past voclosporin trials; the timing of commencement and
completion of clinical trials; and plans and objectives of
management.
It is possible that such results or conclusions may change based
on further analyses of these data. Words such as "plans,"
"intends," “may,” "will," "believe," and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements are based upon our current expectations.
Forward-looking statements involve risks and uncertainties. Our
actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without
limitation, the risk that our analyses, assessment and conclusions
of the results of the future development and commercial potential
of voclosporin set forth in this release may change based on
further analyses of such data, and the risk that our clinical
studies for voclosporin may not lead to regulatory approval. These
and other risk factors are discussed under "Risk Factors" and
elsewhere in Aurinia’s Annual Information Form for the year ended
December 31, 2016 filed with Canadian securities authorities and
available at www.sedar.com and on Form 40-F with the U.S.
Securities Exchange Commission and available at www.sec.gov, each
as updated by subsequent filings, including filings on Form 6-K.
Aurinia expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
Such forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause our actual results,
performance, or achievements to differ materially from any further
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause such
differences include, among other things, the following:
- difficulties, delays, or failures we
may experience in the conduct of our planned AURORA clinical
trial;
- difficulties we may experience in
completing the development and commercialization of
voclosporin;
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity, performance or achievements.
These forward-looking statements are made as of the date hereof and
will only be updated in accordance with applicable law.
We seek Safe Harbor.
Aurinia Pharmaceuticals Inc.Interim Condensed Balance
Sheet (Unaudited)(Expressed in thousands of U.S. dollars, except
per share data)
June 30,
2017
$
December 31,
2016
$
Assets Current assets Cash and cash
equivalents 179,717 39,649 Short term investments 10,071 - Accrued
interest and other receivables 285 86 Prepaid expenses, deposits
and other 2,418 1,683 192,491 41,418
Clinical trial
contract deposits 448 -
Property and equipment 32 29
Acquired intellectual property and other intangible assets
14,829 15,550 207,800 56,997
Liabilities
Current liabilities Accounts payable and accrued
liabilities 3,439 5,791 Current portion of deferred revenue 118 118
Contingent consideration 70 2,021 3,627 7,930
Deferred revenue 501 560
Contingent consideration
3,568 3,419
Derivative warrant liabilities 21,639 9,138
29,335 21,047
Shareholders’ equity
Share capital Common shares 496,726 299,815 Warrants 911 971
Contributed surplus 17,021 17,017
Accumulated
other comprehensive loss (805) (805)
Deficit (335,388)
(281,048) 178,465 35,950 207,800 56,997
Aurinia Pharmaceuticals Inc.Interim Condensed Statements
of Operations and Comprehensive Loss (Unaudited)(Expressed in
thousands of U.S. dollars, except per share data)
Three months ended June 30,
2017
$
June 30,
2016
$
Revenue Licensing revenue 329 29 Research and
development revenue - 25 Contract services - 1 329 55
Expenses Research and development 7,107 2,406 Corporate,
administration and business development 2,901 1,835
Amortization of acquired intellectual
property and otherintangible assets
364 360 Amortization of property and equipment 6 5 Contract
services - 1 Other expense (income) (152) 85 10,226 4,692
Net loss before change in estimated
fair value ofderivative warrant liabilities
(9,897)
(4,637)
Change in estimated fair value of
derivative warrantliabilities
7,498
1,361
Net loss and comprehensive loss for the period
(2,399) (3,276)
Net loss per common share Basic and
diluted loss per common share (0.03) (0.10)
Weighted average number of common shares
outstanding(in thousands)
82,973 32,551
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version on businesswire.com: http://www.businesswire.com/news/home/20170810006077/en/
Aurinia Pharmaceuticals Inc.Investor & Media
Contact:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorChief Financial
Officer:Dennis Bourgeault,
780-643-2260dbourgeault@auriniapharma.com
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