AURORA Phase III Trial in lupus nephritis on
track
Trials in FSGS, MCD and Dry Eye to begin in
the first half of 2018
Cash of $182.4 million as of September 30,
2017
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia”
or the “Company”) has released its financial results for the third
quarter ended September 30, 2017. Amounts, unless specified
otherwise, are expressed in U.S. dollars.
Operational highlights
On October 20, 2017 we announced plans to expand our renal
franchise by investigating voclosporin in focal segmental
glomerulosclerosis (FSGS) and minimal change disease (MCD).
Additionally, we announced plans to evaluate our proprietary
nanomicellar voclosporin ophthalmic solution (VOS) for the
treatment of keratoconjunctivitis sicca or dry eye syndrome (DES).
The advancement of these new indications, in addition to lupus
nephritis (LN), represents an expansion of the company’s strategy,
pipeline and commercial opportunities.
A Phase II proof of concept clinical trial for voclosporin in
FSGS and MCD patients will be initiated in the first half of 2018.
FSGS and MCD affect nearly 150,000 patients globally, accounting
for almost 50% of patients with Nephrotic Syndrome (NS). The
prevalence of FSGS and MCD is increasing through improved
diagnosis, and it has been shown that the control of proteinuria is
important for long-term survival of these patients. Interim data
readouts are anticipated in the second half of 2018.
We also plan to begin a Phase IIa tolerability study of VOS
versus the standard of care for the treatment of DES by the second
quarter of 2018, with data available in the second half of 2018.
Calcineurin inhibitors (CNIs) are a mainstay in the treatment for
DES, and the goal of this program is to develop a best-in-class
treatment option.
Our Phase III clinical trial (AURORA) for the treatment of LN is
on track to complete enrollment in the second half of 2018, with
138 clinical trial sites active around the globe. Additionally,
under voclosporin’s fast-track designation, we intend to utilize a
rolling New Drug Application (NDA) process, with the first module
being submitted in the second half of 2018.
“With the AURORA trial in LN on track to complete enrollment in
the second half of 2018, we’re thrilled to enter this exciting next
phase of development for Aurinia," said Richard Glickman, L.L.D.,
CEO and Chairman of Aurinia Pharmaceuticals. “By expanding our
renal franchise and launching a development program in dry eye, we
have the potential to create significant value for
shareholders.”
Financial Results for the Third Quarter Ended September 30,
2017
Cash, cash equivalents and short term investments were $182.4
million as at September 30, 2017 compared to $189.8 million as of
June 30, 2017, and $39.6 million as at December 31, 2016. We
believe, based on our current plans, that we have sufficient
financial resources to fund our existing LN program, including the
AURORA trial, conduct work on the new indications and fund
operations into 2020.
For the three months ended September 30, 2017, we reported a
consolidated net loss of $13.1 million or $0.16 per common share
compared to a consolidated net loss of $7.4 million or $0.21 per
common share for the three months ended September 30, 2016.
We incurred research and development expenses of $10.8 million
for the three months ended September 30, 2017, as compared to $3.3
million for the same period in 2016. The increase in research and
development expenses for the three months ended September 30, 2017
reflected AURORA clinical expenses such as contract research
organization (CRO) service fees and pass thru costs for activities
including site activations, regulatory submissions, patient
treatment and drug costs for manufacture of voclosporin drug
product, and drug encapsulation, packaging and distribution for the
trial.
We incurred corporate, administration and business development
costs of $2.6 million for the three months ended September 30,
2017, as compared with $1.7 million for the same period in 2016.
These costs included a non-cash stock compensation expense of
$795,000 for the three months ended September 30, 2017 compared to
$469,000 for the three months ended September 30, 2016.
This press release should be read in conjunction with our
unaudited interim condensed consolidated financial statements and
the MD&A for the third quarter ended September 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 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,
FSGS, MCD and DES. The company is headquartered in Victoria, BC and
focuses its development efforts globally.
About FSGS, MCD and NS
NS is a collection of symptoms that indicate kidney damage,
including: large amounts of protein in urine; low levels of albumin
and higher than normal fat and cholesterol levels in the blood, and
edema. Similar to LN, early clinical response and reduction of
proteinuria is thought to be critical to long-term kidney health.
Aurinia is focused specifically on FSGS, a lesion characterized by
persistent scarring identified by biopsy and proteinuria and on
MCD, a kidney disease in which large amounts of protein are lost in
the urine. FSGS and MCD both are causes of NS and characterized by
high morbidity. Currently, there are no approved therapies for FSGS
and MCD in the United States and the European Union.
About DES
DES, or keratoconjunctivitis sicca, is a chronic disease in
which a lack of moisture and lubrication on the eye’s surface
results in irritation and inflammation of the eye. DES is a
multifactorial, heterogeneous disease estimated to affect greater
than 20 million people in the United States.
About 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 percent of
all SLE patients will develop clinical LN requiring treatment.
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 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 Voclosporin
Voclosporin, an investigational drug, is a novel and potentially
best-in-class CNI with clinical data in over 2,400 patients across
indications. Voclosporin is an immunosuppressant, with a
synergistic and dual mechanism of action. By inhibiting
calcineurin, voclosporin blocks IL-2 expression and T-cell mediated
immune responses, and stabilizes the podocyte in the kidney. It has
been shown to have a more predictable pharmacokinetic and
pharmacodynamic relationship, an increase in potency, an altered
metabolic profile and potential for flat dosing compared to legacy
CNIs. Aurinia 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 and until April 2028 with anticipated
pediatric extension.
About VOS
VOS is an aqueous, preservative free nanomicellar solution
containing 0.2% voclosporin intended for use in the treatment of
DES. Studies have been completed in rabbit and dog models, and a
single Phase I has also been completed in healthy volunteers and
patients with DES. VOS has IP protection until 2031. In April 2017,
Aurinia announced an agreement granting Merck Animal Health (MAH)
worldwide rights to develop and commercialize (VOS) for the
treatment of DES in dogs. MAH previously conducted proof of concept
research in dogs suffering from DES, which affects one out of every
22 dogs.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable
Canadian securities law and forward-looking statements within the
meaning of applicable United States securities law. These
forward-looking statements or information include, but are not
limited to statements or information with respect to: AURORA being
on track to complete enrollment in the second half of 2018, the
timing voclosporin being potentially a best-in-class CNI with
robust intellectual property exclusivity; the timing for Aurinia
initiating a Phase II clinical trial for voclosporin in FSGS and
MCD patients; the timing for interim data readouts for the Phase II
clinical trial for FSGS and MCD patients; the timing for
commencement of a Phase IIa tolerability study of VOS; the timing
for data availability for the Phase IIa tolerability study; the
anticipated commercial potential of voclosporin for the treatment
of LN, NS, FSGS, DES and other autoimmune diseases; that the
expansion of the renal franchise could create significant value for
shareholders and that Aurinia has sufficient financial resources to
fund the existing LN program, including the AURORA trial, conduct
work on the new indications and fund operations into 2020. It is
possible that such results or conclusions may change based on
further analyses of these data Words such as “anticipate”, “will”,
“believe”, “estimate”, “expect”, “intend”, “target”, “plan”,
“goals”, “objectives”, “may” and other similar words and
expressions, identify forward-looking statements. We have made
numerous assumptions about the forward-looking statements and
information contained herein, including among other things,
assumptions about: the market value for the LN program; that
another company will not create a substantial competitive product
for Aurinia’s LN business without violating Aurinia’s intellectual
property rights; the burn rate of Aurinia’s cash for operations;
the costs and expenses associated with Aurinia’s clinical trials;
the planned studies achieving positive results; Aurinia being able
to extend its patents on terms acceptable to Aurinia; and the size
of the LN market. Even though the management of Aurinia believes
that the assumptions made and the expectations represented by such
statements or information are reasonable, there can be no assurance
that the forward-looking information will prove to be accurate.
Forward-looking information by their nature are based on
assumptions and involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or
achievements of Aurinia to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
in forward-looking statements or information. Such risks,
uncertainties and other factors include, among others, 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; the market for the LN business may not be as
estimated; Aurinia may have to pay unanticipated expenses;
estimated costs for clinical trials may be underestimated,
resulting in Aurinia having to make additional expenditures to
achieve its current goals; Aurinia not being able to extend its
patent portfolio for voclosporin; and competitors may arise with
similar products. Although we have attempted to identify factors
that would cause actual actions, events or results to differ
materially from those described in forward-looking statements and
information, there may be other factors that cause actual results,
performances, achievements or events to not be as anticipated,
estimated or intended. Also many of the factors are beyond our
control. There can be no assurance that forward-looking statements
or information will prove to be accurate, as actual results and
future events could differ materially from those anticipated in
such statements. Accordingly you should not place undue reliance on
forward-looking statements or information.
Except as required by law, Aurinia will not update
forward-looking information. All forward-looking information
contained in this press release is qualified by this cautionary
statement. Additional information related to Aurinia, including a
detailed list of the risks and uncertainties affecting Aurinia and
its business can be found in Aurinia’s most recent Annual
Information Form available by accessing the Canadian Securities
Administrators’ System for Electronic Document Analysis and
Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities
and Exchange Commission’s Electronic Document Gathering and
Retrieval System (EDGAR) website at www.sec.gov/edgar.
We seek Safe Harbor.
Aurinia Pharmaceuticals Inc.
Interim Condensed Balance Sheet
(Unaudited)
(Expressed in thousands of U.S. dollars,
except per share data)
September
30,2017$
December 31,2016$
Assets Current assets Cash and cash
equivalents 87,546 39,649 Short term investments 94,860 - Accrued
interest and other receivables 415 86 Prepaid expenses, deposits
and other 2,064 1,683 184,885 41,418
Clinical
trial contract deposits 448 -
Property and equipment 27
29
Acquired intellectual property and other intangible
assets 14,472 15,550 199,832 56,997
Liabilities Current liabilities Accounts
payable and accrued liabilities 6,665 5,791 Current portion of
deferred revenue 118 118
Contingent consideration 72
2,021 6,855 7,930
Deferred revenue 472 560
Contingent consideration 3,654 3,419
Derivative warrant
liabilities 21,207 9,138 32,188 21,047
Shareholders’ equity Share capital
Common shares 498,698 299,815 Warrants 906 971
Contributed surplus 17,442 17,017
Accumulated other
comprehensive loss (894) (805)
Deficit (348,508)
(281,048) 167,644 35,950 199,832 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
September
30,2017$
September
30,2016$
Revenue Licensing revenue 29 29 Contract services -
2 29 31
Expenses Research and
development 10,807 3,342 Corporate, administration and business
development 2,650 1,716 Amortization of acquired intellectual
property and other intangible assets 357 357 Amortization of
property and equipment 5 5 Contract services - 1 Other expense
(income) (315) 1,078 13,504 6,499
Net loss before change in estimated fair value of derivative
warrant liabilities
(13,475)
(6,468)
Change in estimated fair value of derivative warrant
liabilities
355
(951)
Net loss for the period (13,120) (7,419)
Other comprehensive income (loss)
Item that may be reclassified subsequently
to income (loss)
Net change in fair value of short term
investments
(89) -
Net comprehensive loss for the period
(13,209) (7,419)
Net loss per common share
(expressed in $ per share) Basic and diluted loss per common share
(0.16) (0.21)
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Aurinia Pharmaceuticals Inc.Investors &
Media:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorChief Financial
Officer:Dennis Bourgeaultdbourgeault@auriniapharma.com