Full Press Release Details
Reports Second Quarter 2016 Financial Results and Operational Highlights
private placement for gross proceeds of $7.08 million
results support the use of voclosporin for the treatment of lupus
topline primary endpoint results imminent
VICTORIA, British Columbia--(BUSINESS WIRE)--August 5, 2016--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
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
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
AURA-LV 24 week primary end point data release - prior to the end of
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
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