Completed private placement for gross
proceeds of $7.08 million
AURION results support the use of
voclosporin for the treatment of lupus nephritis
AURA topline primary endpoint results
imminent
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH-TSX:AUP) (“Aurinia” or
the “Company”) has released its financial results for the second
quarter ended June 30, 2016. Amounts, unless specified otherwise,
are expressed in U.S. dollars.
The Aurinia team is focused on preparations for the AURA primary
end point data release expected prior to the end of August, 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
additional 24 week data points.
The Company is also in the process of completing assessments of
key markets in the Americas, Europe and Asia. The Company will
share more on these developments during future investor
presentations.
“We are fast approaching a pivotal event for Aurinia with
primary endpoint data from the AURA trial expected very soon. The
Aurinia team is excited to have reached this stage in the
development of voclosporin for lupus nephritis. We plan to continue
to execute on initiatives to maximize shareholder value and help
bring a desperately needed therapy to market for patients suffering
from this disease,” said Charlie Rowland, CEO of Aurinia
Pharmaceuticals Inc.
Operational and Corporate Developments
AURA Phase 2b Clinical Trial Update
On January 19, 2016, the Company announced completion of patient
enrollment of its AURA Phase 2b clinical trial at 265 patients (the
target number of patients was 258).
Un-blinding and disclosure of the primary trial data is
scheduled within approximately one month of the last enrolled
patient completing 24 weeks of active treatment. Therefore, the
Company expects that the primary end-point results of the AURA
trial will be released prior to the end of August, 2016.
AURION Study Update
On June 28, 2016 the Company announced that it completed an
analysis of the first 7 patients to complete 24 weeks in its
open-label AURION (Aurinia early
Urinary protein Reduction Predicts
Response) study. At 24 weeks 57% (4/7) of patients continued to be
in complete remission as measured by a urinary protein creatinine
ratio of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant
steroid dose of less than 5mg/day. Among these seven AURION
patients there was a 54% mean reduction in proteinuria at 24 weeks
compared to pre-treatment levels along with consistent improvements
in C3, C4 and anti-DS DNA. Renal function as measured by eGFR
remained stable and no new safety signals were observed.
Private Placement Financing
On June 22, 2016 the Company completed a private placement of 3
million units of the Company at US$2.36 per unit for total gross
proceeds of US$7.08 million. Each unit consisted of one common
share of the Company and a 0.35 of one common share purchase
warrant exercisable for a period of two years from the date of
issuance at an exercise price of US$2.77.
At the Market (ATM) Facility
On July 22, 2016 the Company entered into a Controlled Equity
Offering Sales Agreement with Cantor Fitzgerald & Co. (“Cantor
Fitzgerald”) pursuant to which the Company may from time to time
sell, through at-the-market (“ATM”) offerings with Cantor
Fitzgerald acting as sales agent, such common shares as would have
an aggregate offer price of up to US$10 million.
The Company expects the following milestones and events in
the second half of 2016:
- AURA-LV 24 week primary end point data
release – prior to the end of August 2016
- AURION 10 patients to 24 weeks –
Q3/2016
- Investor Day – September 2016
- End of Phase 2 meeting with FDA–
Q4/2016
- Scientific meetings: ACR & ASN
Financial Results for the Second Quarter Ended June 30,
2016
The Company had cash, cash equivalents and short term
investments of $12.1 million at June 30, 2016 compared to $10.5
million at March 31, 2016 and $15.8 million at December 31, 2015.
Net cash used in operating activities was $5.0 million for the
second quarter ended June 30, 2016. The Company generated $6.6
million from financing activities during the quarter as a result of
completing the private placement on June 22, 2016.
For the second quarter ended June 30, 2016, the Company reported
a consolidated net loss of $3.3 million or $0.10 per common share,
as compared to a consolidated net loss of $733,000 or $0.02 per
common share for the same period in 2015. The increase in the
reported consolidated net loss was primarily attributable to a
reduction in the non-cash gain on the quarterly fair value
revaluation of the derivative warrant liability of $4.0 million
offset to a lesser degree by a reduction in research and
development expenses of $1.9 million in the second quarter ended
June 30, 2016 compared to the same period in 2015.
For the six months ended June 30, 2016, the consolidated net
loss was $7.5 million or $0.23 per common share compared to a
consolidated net loss of $9.3 million or $0.29 per common share for
the comparable period in 2015. The lower consolidated net loss
reflected a decrease in research and development expenses of $1.9
million for the 2016 period compared to the same period in
2015.
Research and development expenses decreased to $2.4 million for
the three months ended June 30, 2016, compared to $4.3 million for
the three months ended June 30, 2015 as the costs related to the
active treatment phase of the AURA trial have decreased as patients
complete the trial. The Company incurred net research and
development expenditures of $5.7 million for the six months ended
June 30, 2015, as compared to $7.6 million for the same period in
2015.
Corporate, administration and business development expenses
increased to $1.8 million for the three months ended June 30, 2016,
compared to $1.4 million for the same period in 2015. The Company
incurred corporate, administration and business development
expenses of $3.0 million for the six months ended June 30, 2016
compared to $3.3 million for the same period in 2015.
The unaudited interim condensed consolidated financial
statements and the MD&A for the second quarter ended June 30,
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.
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/20160805005117/en/
Aurinia Pharmaceuticals Inc.Mr. Michael Martin, 250-708-4272Fax:
250-744-2498Chief Operating
Officermmartin@auriniapharma.comorMr.
Dennis Bourgeault, 780-643-2260Fax: 780-484-4105Chief Financial
Officerdbourgeault@auriniapharma.com