Enrollment completed in Phase 2b clinical
trial with data read out in third quarter of 2016
FDA Fast Track designation granted to
voclosporin for lupus nephritis
Early AURION results support the use of
voclosporin as a component of multi-targeted therapy in lupus
nephritis
Company leadership team strengthened with
expanded capabilities
Aurinia Pharmaceuticals Inc.
(NASDAQ:AUPH)(TSX:AUP) (“Aurinia” or the “Company”) has released
its financial results for the first quarter ended March 31, 2016.
Amounts, unless specified otherwise, are expressed in U.S.
dollars.
The first quarter of 2016 was highlighted by
the completion of patient enrollment in our Phase 2b (AURA)
clinical trial and obtaining fast track designation from the FDA
for voclosporin. In addition to these clinical and regulatory
successes, the Company received promising data from the open-label
AURION study that further supports our hypothesis on the potential
for multi-targeted therapy with voclosporin for the treatment of
lupus nephritis (LN). The team is focused on preparations for the
AURA primary end point data release in the latter half of the third
quarter of 2016 and initiation of the Phase 3 program in 2017. The
Company is making the necessary investments now to ensure the team
has the tools to deliver future success. The remainder of the year
will also see further data releases from the AURION study including
some 24 and 48 week data points.
The Company will also be completing assessments
of key markets in the Americas, Europe and Asia. The Company will
share more on these developments during future investor
presentations.
“While only being in this role a short time, I
am both excited and greatly encouraged by the performance and focus
of the team. I plan to continue to execute on initiatives to
maximize shareholder value and help bring a desperately needed
therapy to market for patients suffering from LN.” said Charlie
Rowland, CEO of Aurinia Pharmaceuticals Inc.
Key Developments
AURA Phase 2b Clinical Trial Update –
Patient Enrollment Completed
On January 19, 2016, the Company announced
completion of patient enrollment of its AURA clinical trial at 265
patients. This Phase 2b trial, is a randomized, controlled,
double-blind study comparing the efficacy of voclosporin as a
component of multi-targeted therapy against placebo in achieving
remission in patients with active lupus nephritis (LN). AURA is one
of the largest prospective registration-quality studies ever
conducted within this specific disease area.
FDA Fast Track
On March 2, 2016 the Company announced that the
U.S. Food and Drug Administration (FDA) granted Fast Track
designation for voclosporin, the Company’s next generation
calcineurin inhibitor, for the treatment of LN.
The Fast Track program was created by the FDA
to facilitate the development and expedite the review of new drugs
that are intended to treat serious or life-threatening conditions
and that demonstrate the potential to address significant unmet
medical needs. Compounds that receive this FDA designation benefit
from more frequent meetings and communications with the FDA to
review the drug’s development plan including the design of clinical
trials and the use of biomarkers to support approval. Additionally,
Fast Track designation allows the Company to submit parts of the
New Drug Application (NDA) on a rolling basis for review as data
becomes available. The Company expects to analyse and review the
AURA data with the FDA later in 2016 in order to determine the
appropriate next steps.
AURION Study Update
On February 8, 2016 the Company announced that
it had completed a preliminary analysis of its AURION (Aurinia early Urinary
protein Reduction Predicts Response) study. In the first seven
patients, of the 10 patients enrolled in the study, that have
reached at least eight weeks of therapy in the AURION study, 100%
(7/7) achieved at least a 25% reduction in proteinuria compared to
study entry. A 25% reduction in proteinuria at eight weeks has been
shown to be predictive of a positive clinical response at 24
weeks1. Additionally, in the first eight weeks of the open-label
AURION study an overall mean reduction of proteinuria of 72%
compared to pre-treatment levels was observed, and 57% (4/7) of
these patients achieved complete remission as defined by a urinary
protein creatinine ratio of ≤ 0.5mg/mg. Overall renal function as
measured by eGFR in these patients also remained stable. The
Company plans to release further AURION data as it becomes
available.
Strengthening Leadership and
Capabilities
On April 11, 2016 the Company appointed Mr.
Charles A. Rowland, Jr., MBA, CPA, as its Chief Executive Officer.
Mr. Rowland has more than 30 years of experience in
pharmaceutical operations, strategic value creation as well as
financial management. He served as the Vice President and Chief
Financial Officer of ViroPharma Incorporated, an international
biopharmaceutical company, until it was acquired by Shire plc for
$4.2B in January 2014. As a member of the executive team, he was
key to developing the global strategic direction of the company,
its international expansion and its strong financial
position.
On April 29, 2016 the Company appointed Bradley
J. Dickerson as an officer of the Company in the position of
General Manager of the Americas and Global Commercial Assessment.
Mr. Dickerson has more than 15 years of experience in the
healthcare industry with a focus on pharmaceutical market access,
distribution and patient services. He served as Vice President,
Access and Reimbursement at NPS Pharmaceuticals, until it was
acquired by Shire plc. Prior to his role at NPS, Mr. Dickerson was
Director of Managed Markets at ViroPharma with responsibility for
all market access functions. He also provided leadership for the
launch and ongoing commercialization of Cinryze®.
Expected Upcoming Milestones and
Events
- AURION 10 patients to 8 weeks –
Q2/2016
- AURION 7 patients to 24 weeks –
Q2/2016
- AURA-LV 24 week primary end-point data
release – Q3/2016
- AURION 10 patients to 24 weeks –
Q3/2016
- Filing for Breakthrough Designation –
Q3/2016-pending data from AURA trial – 24 week results
- Investor Day-Fall/2016
- End of Phase 2 meeting with FDA –
Q4/2016
- Scientific meetings:
- Abstract presentation – European Renal
Association / European Dialysis and Transplantation Meeting
(ERA/EDTA) –Q2/2016
- Poster presentation – European League
Against Rheumatism (EULAR) – Q2/2016
Financial Results for the First Quarter
Ended March 31, 2016
For the first quarter ended March 31, 2016, the
Company reported a consolidated net loss of $4.3 million or $0.13
per common share, as compared to a consolidated net loss of $8.6
million or $0.27 per common share for the same period in 2015.
The decrease in the net loss was primarily
attributable to recording a non-cash gain on revaluation of
derivative warrant liability of $664,000 in 2016 compared to a
non-cash loss on revaluation of derivative warrant liability of
$2.9 million for the comparable period in 2015 and a reduction in
stock compensation expense of $955,000 in the first quarter ended
March 31, 2016 compared to the corresponding period in 2015.
After adjusting for the non-cash impact of the
revaluation of the derivative warrant liability, the net loss from
operations for the first quarter ended March 31, 2016 was $4.9
million compared to $5.7 million for the corresponding period in
2015.
The Company incurred net research and
development expenditures of $3.3 million for the first quarter
ended March 31, 2016, as compared to $3.3 million for the same
period in 2015. Research and development expenditures for both
periods related primarily to drug distribution, patient enrollment
and treatment activities associated with the AURA trial.
The Company incurred corporate, administration
and business development costs of $1.2 million for the first
quarter ended March 31, 2016, as compared with $1.9 million for the
same period in 2015. These costs included a non-cash stock
compensation expense of $261,000 in 2016 compared to $897,000 in
2015.
The Company had cash, cash equivalents and
short term investments of $10.5 million as at March 31, 2016
compared to $15.8 million as at December 31, 2015. In order to
complete the AURA LN clinical trial and be able to undertake
further development of voclosporin, the Company will need to raise
additional funds within the next 12 months.
The unaudited interim condensed consolidated
financial statements and the MD&A for the first quarter ended
March 31, 2016 are accessible on Aurinia's website at
www.auriniapharma.com or on SEDAR at www.sedar.com or on EDGAR at
www.sec.gov/edgar.
1Dall’Era, M., Stone, D., Levesque, V.,
Cisternas,M., & Wofsy, D. (2011).Arthritis Care and Research,
63(3), 351–357.
About Aurinia:
Aurinia is a clinical stage pharmaceutical
company focused on the global nephrology market. The fully-enrolled
AURA clinical trial is evaluating the efficacy of its lead drug,
voclosporin, as a treatment for active LN. LN is an inflammation of
the kidneys, that if inadequately treated can lead to end-stage
renal disease, making LN a serious and potentially life-threatening
condition.
Voclosporin is a novel and potentially
best-in-class calcineurin inhibitor (“CNI”) with extensive clinical
data in over 2,000 patients in other indications. Voclosporin is
made by a modification of a single amino acid of the cyclosporine
molecule (a CNI approved for use in transplant patients since
1983). This modification results in a more predictable
pharmacokinetic and pharmacodynamic relationship, an increase in
potency vs. cyclosporine, an altered metabolic profile, and
potential for flat dosing.
About AURA:
The AURA trial is an adequate and
well-controlled clinical trial that enrolled 265 patients and is
being conducted in over 20 countries worldwide. This trial will
compare the efficacy of voclosporin against placebo in achieving
remission in patients with active lupus nephritis. The AURA trial
designed to demonstrate that voclosporin can induce a rapid and
sustained reduction of proteinuria in the presence of extremely low
steroid exposure. It will compare two dosage groups of voclosporin
(23.7mg and 39.5mg) compared to placebo, with all patients
receiving mycophenolate mofetil (MMF) and oral corticosteroids as
background therapy. There will be a primary analysis to determine
complete remission at week 24 (confirmed at 26 weeks) and various
secondary analyses at week 48 which include biomarkers and markers
of non-renal SLE.
About AURION:
The AURION study is an open label, exploratory
study being conducted at two sites in Malaysia to assess the short
term predictors of response using voclosporin (23.7mg) in
combination with mycophenolate mofetil and oral corticosteroids in
patients with active lupus nephritis. This study will examine
biomarkers of disease activity at 8 weeks and their ability to
predict response at 24 and 48 weeks.
Forward-Looking Statements
A statement is forward-looking when it uses
what the Company knows and expects today to make a statement about
the future. Forward-looking statements may include words such as
“anticipate”, “believe”, “intend”, “expect”, “goal”, “may”,
“outlook”, “plan”, “seek”, “should”, “strive”, “target”, “could”,
“continue”, “potential” and “estimated”, or the negative of such
terms or comparable terminology. You should not place undue
reliance on forward-looking statements, particularly those
concerning anticipated events relating to the development, clinical
trials, regulatory approval, and marketing of the Company’s product
and the timing or magnitude of those events, as they are inherently
risky and uncertain.
Securities laws encourage companies to disclose
forward-looking information so that investors can get a better
understanding of the Company’s future prospects and make informed
investment decisions. In this press release, these statements may
include, without limitation:
- plans to fund the Company’s
operations;
- summary statements relating to results
of the past voclosporin trials or plans to advance the development
of voclosporin;
- the timing of the release of the
primary end-point results of AURA ;
- the timing of the analysis and review
of the AURA data with the FDA;
- the timing of commencement and
completion of clinical trials;
- voclosporin being a best-in-class
calcineurin inhibitor;
- the Company’s anticipated future
financial position, future revenues and projected costs;
- the Company’s intention to raise
additional funds in the next 12 months;
- the timing of the Company’s anticipated
milestones for 2016; and
- plans and objectives of
management.
Such statements reflect the Company’s current
views with respect to future events and are subject to risks and
uncertainties and are necessarily based on a number of estimates
and assumptions that, while considered reasonable by the Company,
as at the date of such statements, are inherently subject to
significant business, economic, competitive, political, scientific
and social uncertainties and contingencies, many of which, with
respect to future events, are subject to change. The factors and
assumptions used by the Company to develop such forward-looking
statements include, but are not limited to: the assumption that the
Company will be able to reach agreements with regulatory agencies
on executable development programs; the assumption that recruitment
to clinical trials will occur as projected; the assumption that the
Company will successfully complete its clinical programs on a
timely basis, including the AURA clinical trial currently in
progress, to enable the Company to proceed to conduct future
required LN clinical trials and meet regulatory requirements for
approval of marketing authorization applications and new drug
approvals; the assumption the regulatory requirements will be
maintained; the assumption that the Company will be able to
manufacture and secure a sufficient supply of voclosporin on a
timely basis to successfully complete the development and
commercialization of voclosporin; the assumption that market data
and reports reviewed by the Company are accurate; the assumptions
relating to the availability of capital on terms that are
favourable to the Company; the assumption that the Company will be
able to attract and retain skilled staff; the assumption that
general business and economic conditions will be maintained, and
the assumptions relating to the feasibility of future clinical
trials.
It is important to know that:
- Actual results could be materially
different from what the Company expects if known or unknown risks
affect its business, or if the Company’s estimates or assumptions
turn out to be inaccurate. As a result, the Company cannot
guarantee that any forward-looking statement will materialize and,
accordingly, you are cautioned not to place undue reliance on these
forward-looking statements.
- Forward-looking statements do not take
into account the effect that transactions or non-recurring or other
special items announced or occurring after the statements are made
may have on the Company’s business. For example, they do not
include the effect of mergers, acquisitions, other business
combinations or transactions, dispositions, sales of assets, asset
write-downs or other charges announced or occurring after the
forward-looking statements are made. The financial impact of such
transactions and non-recurring and other special items can be
complex and necessarily depends on the facts particular to each of
them. Accordingly, the expected impact cannot be meaningfully
described in the abstract or presented in the same manner as known
risks affecting the Company’s business.
- The Company disclaims any intention and
assumes no obligation to update any forward-looking statements even
if new information becomes available, as a result of future events,
new information, or for any other reason except as required by
law.
Such forward-looking statements involve known
and unknown risks, uncertainties, and other factors that may cause
the Company’s 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:
- the need for additional capital to fund
the Company’s development programs and the effect of capital market
conditions and other factors on capital availability;
- difficulties, delays, or failures the
Company may experience in the conduct of and reporting of results
of its clinical trials for voclosporin, and in particular its
current AURA clinical trial;
- difficulties, delays or failures in
obtaining regulatory approvals for the initiation of clinical
trials;
- difficulties the Company may experience
in completing the development and commercialization of
voclosporin;
Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, the Company cannot guarantee future results, levels of
activity, performance or achievements. These forward-looking
statements are made as of the date hereof.
We seek Safe Harbor.
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version on businesswire.com: http://www.businesswire.com/news/home/20160511006569/en/
Aurinia Pharmaceuticals Inc.Mr. Michael Martin,
250-708-4272Chief Operating OfficerFax: (250)
744-2498mmartin@auriniapharma.comorMr. Dennis
Bourgeault, 780-643-2260Chief Financial OfficerAurinia
Pharmaceuticals Inc.Fax:
780-484-4105dbourgeault@auriniapharma.com