-- Pivotal Phase III ADVOCATE trial of avacopan
on track to complete enrollment in mid-2018 as projected --
ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company
developing new medications targeted at inflammatory and autoimmune
diseases and cancer, today announced financial results for the
second quarter ended June 30, 2017.
“We’ve had a highly productive second quarter, activating many
new sites in our avacopan Phase III ADVOCATE trial, which is
producing a multiplier effect on patient enrollment,” said Thomas
J. Schall, Ph.D., President and Chief Executive Officer of
ChemoCentryx. “Now we are launching a clinical trial for avacopan
in a second indication, C3G, executing on our ‘pipeline in a drug’
strategy. We are also working with regulatory authorities on the
design of a third trial, involving our CCR2 inhibitor, CCX140,
intended to support registration in patients with Focal Segmental
Glomerulosclerosis (FSGS).”
Recent Highlights
- ChemoCentryx’s Phase III ADVOCATE trial of avacopan (formerly
CCX168) for the treatment of ANCA-associated vasculitis is gaining
momentum, with 143 sites activated in 18 countries across the
world. The trial will test the safety and efficacy of avacopan
following 12 months of treatment and will include approximately 300
patients. Enrollment rates per activated sites are exceeding
projections, and the trial is on track to complete enrollment by
mid 2018. In addition to testing the effect of avacopan on
improving active vasculitis, the ADVOCATE trial will also test the
effect of avacopan on preventing a recurrence of vasculitis, one of
the major limitations of the current standard of care for this
disease.
- In May 2017, ChemoCentryx announced that the European Medicines
Agency granted orphan medicinal product designation for avacopan in
the treatment of patients with C3G, which followed shortly after
orphan drug designation was granted for avacopan in the treatment
of C3G by the U.S. Food and Drug Administration. The Company is
launching a registration-supporting trial of avacopan in C3G
patients. There is currently no approved therapy for C3G.
- In June 2017, ChemoCentryx announced program advances in two
oral presentations that were given during the 54th European Renal
Association - European Dialysis and Transplant Association
(ERA-EDTA) Congress in Madrid, which highlighted an additional
potential clinical indication for avacopan and the potential for
CCR2 inhibition in FSGS. The Company plans to launch a
registration-supporting trial of CCR2 inhibitor CCX140 in patients
with FSGS later this year.
Second Quarter 2017 Financial Results
Pro forma cash, cash equivalents, investments and remaining
upfront commitments totaled $166.7 million at June 30, 2017.
Revenue was $8.9 million for the second quarter, compared to
$2.8 million for the same period in 2016. The increase in
revenues from 2016 to 2017 was due to; (i) amortization of the
upfront license fee commitments from Vifor pursuant to the avacopan
and CCX140 agreements, as well as (ii) collaboration revenue for
development services under the CCX140 agreement.
Research and development expenses were $14.3 million for the
second quarter, compared to $9.1 million for the same period in
2016. The increase in research and development expenses from 2016
to 2017 was primarily attributable to higher Phase III development
expenses due to the initiation of the avacopan Phase III ADVOCATE
trial in patients with AAV in the fourth quarter of 2016 and
start-up expenses related to the Phase II clinical trial of
avacopan for the treatment of C3G. These increases were
partially offset by decreases in (i) Phase I clinical development
expense due to the completion of enrollment in the Phase I clinical
trial for CCX872 in patients with advanced pancreatic cancer in
2016 and (ii) Phase II development expense due to the completion of
the avacopan CLEAR and CLASSIC Phase II clinical trials for the
treatment of AAV in 2016.
General and administrative expenses were $4.2 million for the
second quarter, compared to $3.9 million for the same period in
2016. The increase from 2016 to 2017 was primarily due to higher
intellectual property related expenses and accounting related fees
associated with preparing to meet the requirements pursuant to the
Sarbanes-Oxley Act of 2002.
Net losses for the second quarter were $9.2 million, compared to
$10.0 million for the same period in 2016.
Total shares outstanding at June 30, 2017 were approximately
48.6 million shares.
The Company expects to utilize cash and cash equivalents in the
range of $50 million and $55 million in 2017.
Conference Call and Webcast
The Company will host a conference call and webcast today,
August 8, 2017 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time.
To participate by telephone, please dial 877-303-8028 (Domestic) or
760-536-5167 (International). The conference ID number is 58685442.
A live and archived audio webcast can be accessed through the
Investors section of the Company's website at www.ChemoCentryx.com.
The archived webcast will remain available on the Company's website
for fourteen (14) days following the conference call.
About ChemoCentryx
ChemoCentryx is a biopharmaceutical company developing new
medications targeted at inflammatory and autoimmune diseases and
cancer. ChemoCentryx targets the chemokine and chemoattractant
systems to discover, develop and commercialize orally-administered
therapies. ChemoCentryx is currently focusing on its late stage
drug candidates for patients with rare kidney diseases, avacopan
(CCX168) and CCX140.
Avacopan is an orally-administered small molecule that is a
selective inhibitor of the complement C5a receptor, or C5aR.
Avacopan is in Phase III development for the treatment of
anti-neutrophil cytoplasmic auto-antibody-associated vasculitis
(AAV). In clinical studies to date, avacopan was shown to be safe,
well tolerated and provided effective control of the disease while
allowing elimination of high-dose steroids, part of the current
standard of care. Avacopan is also being developed in patients with
C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome
(aHUS). The U.S. Food and Drug Administration has granted
avacopan orphan-drug designation for AAV, C3G and aHUS.
The European Medicines Agency (EMA) has granted orphan
medicinal product designation for avacopan for the treatment of two
forms of AAV: microscopic polyangiitis and granulomatosis with
polyangiitis (formerly known as Wegener's granulomatosis), as well
as for C3G. Avacopan was also granted access to the EMA’s PRIority
MEdicines (PRIME) initiative, which supports
accelerated assessment of investigational therapies addressing
unmet medical need.
The Company’s other late stage drug candidate is CCX140, an
inhibitor of the chemokine receptor known as CCR2, which is
currently being developed for patients with focal segmental
glomerulosclerosis (FSGS), a debilitating kidney disease.
ChemoCentryx’s Kidney Health Alliance with Vifor Pharma provides
Vifor Pharma with exclusive rights to commercialize avacopan and
CCX140 in markets outside of the U.S. and China.
ChemoCentryx also has early stage drug candidates that target
chemoattractant receptors in other Inflammatory and autoimmune
diseases and in cancer.
Forward-Looking Statements
ChemoCentryx cautions that statements included in this press
release that are not a description of historical facts are
forward-looking statements. Words such as "may," "could," "will,"
"would," "should," "expect," "plan," "anticipate," "believe,"
"estimate," "intend," "predict," "seek," "contemplate,"
"potential," "continue" or "project" or the negative of these terms
or other comparable terminology are intended to identify
forward-looking statements. These statements include the Company's
statements regarding the timing of potential clinical trials,
anticipated enrollment in clinical trials, whether the next
clinical studies with avacopan in C3G and with CCX140 in FSGS will
serve as registration-supporting trials, the Company’s expectations
regarding its utilization of cash and cash equivalents and whether
the Company’s drug candidates will be shown to be effective in
ongoing or future clinical trials. The inclusion of forward-looking
statements should not be regarded as a representation
by ChemoCentryx that any of its plans will be achieved.
Actual results may differ from those set forth in this release due
to the risks and uncertainties inherent in
the ChemoCentryx business and other risks described in
the Company's filings with the Securities and Exchange
Commission ("SEC"). Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof, and ChemoCentryx undertakes no
obligation to revise or update this news release to reflect events
or circumstances after the date hereof. Further information
regarding these and other risks is included under the heading "Risk
Factors" in ChemoCentryx's periodic reports filed with
the SEC, including ChemoCentryx's Annual Report on
Form 10-K filed with the SEC on March 14, 2017 and
its other reports which are available from
the SEC's website (www.sec.gov) and
on ChemoCentryx's website (www.chemocentryx.com) under
the heading "Investors." All forward-looking statements are
qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
Source: ChemoCentryx, Inc.
CCXI-G
ChemoCentryx,
Inc. |
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Consolidated Statement of Operations
Data |
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(in thousands, except per share data) |
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2017 |
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2016 |
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2017 |
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2016 |
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Consolidated Statement of Operations Data: |
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Revenue: |
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Collaboration and license revenue |
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$ |
8,937 |
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$ |
2,620 |
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$ |
17,167 |
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$ |
2,620 |
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Grant revenue |
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- |
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175 |
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- |
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175 |
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Total revenue |
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8,937 |
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2,795 |
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17,167 |
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2,795 |
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Operating
expenses: |
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Research and development |
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14,329 |
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9,062 |
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24,299 |
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20,307 |
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General and administrative |
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4,184 |
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3,877 |
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8,757 |
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7,961 |
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Total operating expenses |
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18,513 |
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12,939 |
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33,056 |
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28,268 |
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Loss from
operations |
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(9,576 |
) |
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(10,144 |
) |
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(15,889 |
) |
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(25,473 |
) |
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Interest income |
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336 |
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161 |
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653 |
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247 |
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Net loss |
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$ |
(9,240 |
) |
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$ |
(9,983 |
) |
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$ |
(15,236 |
) |
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$ |
(25,226 |
) |
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Basic and
diluted net loss per share |
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$ |
(0.19 |
) |
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$ |
(0.22 |
) |
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$ |
(0.32 |
) |
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$ |
(0.56 |
) |
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Shares used
to compute basic and diluted net loss per share |
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48,224 |
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45,785 |
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48,169 |
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45,031 |
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June 30, |
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December 31, |
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2017 |
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2016 |
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(in thousands) |
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Consolidated Balance Sheet Data |
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Cash, cash
equivalents and investments (1) |
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$ |
136,644 |
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$ |
123,761 |
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Accounts
receivable (1) |
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|
218 |
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30,205 |
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Working capital |
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79,476 |
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110,356 |
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Total assets |
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140,527 |
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155,872 |
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Accumulated
deficit |
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(322,295 |
) |
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(307,059 |
) |
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Total
stockholders’ equity |
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40,915 |
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49,889 |
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(1) Cash, cash equivalents and investments and accounts
receivable exclude the remaining $30 million cash commitments due
from Vifor Pharma, $20 million of which is due in December 2017 and
$10 million due in February 2018, in connection with the CCX140
Agreement and Avacopan Amendment, respectively.
Contacts:
Susan M. Kanaya
Executive Vice President,
Chief Financial and Administrative Officer
investor@chemocentryx.com
Media:
Denise Powell
denise@redhousecomms.com
510.703.9491
Investors:
Steve Klass, Burns McClellan
212.213.0006
sklass@burnsmc.com
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