-- Phase III ADVOCATE trial of avacopan remains
on track to complete enrollment in mid-2018 --
ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company
developing new medications targeted at inflammatory and autoimmune
diseases and cancer, today announced financial results for the
third quarter ended September 30, 2017.
“Our pursuit of new and better medicines for people with orphan
diseases has been relentless,” said Thomas J. Schall, Ph.D.,
President and Chief Executive Officer of ChemoCentryx. “Dedicated
to creating value for patients and shareholders alike, we at CCXI
started with basic science in the discovery of novel molecules that
selectively inhibit chemoattractant receptors, which are the
molecular guidance systems of destructive inflammatory cells
involved in a wide range of diseases and conditions. Now we have
advanced two of those novel molecules, avacopan and CCX140, well
into late-stage clinical trials. In doing so, we move closer to the
next phase of value creation – the potential commercialization of
our targeted medicines to help those suffering from serious renal
diseases.”
Recent Highlights
- ChemoCentryx’s Phase III ADVOCATE trial of avacopan for the
treatment of ANCA-associated vasculitis has surpassed 30 percent of
its target patient enrollment with more than 185 sites activated.
The trial will test the safety and efficacy of avacopan following
12 months of treatment and will include approximately 300 patients.
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.
- ChemoCentryx recently received orphan designation in
Switzerland from SwissMedic for avacopan for the treatment of two
forms of ANCA-vasculitis: microscopic polyangiitis and
granulomatosis with polyangiitis (formerly known as Wegener's
granulomatosis). This designation is in addition to the previously
received orphan designations from the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) for
avacopan to treat ANCA-vasculitis.
- ChemoCentryx recently launched a registration-supporting
clinical trial to study avacopan in a second indication, C3
Glomerulopathy (C3G), a rare disorder that often affects the young,
requiring dialysis and often kidney transplant. Sites have been
activated for the trial and patient enrollment has begun. Earlier
this year ChemoCentryx announced that it had received both EMA
orphan medicinal product designation and FDA orphan drug
designation for avacopan in the treatment of C3G.
- ChemoCentryx is launching a third registration-supporting
trial, involving its CCR2 inhibitor, CCX140, to treat the
debilitating kidney disorder known as Focal Segmental
Glomerulosclerosis (FSGS), for which there is no approved treatment
option. The Company plans to launch a trial in the fourth quarter
of 2017.
Third Quarter 2017 Financial Results
Pro forma cash, cash equivalents, investments and remaining
upfront commitments totaled $154.8 million at September 30,
2017.
Revenue was $9.0 million for the third quarter,
compared to $4.1 million for the same period in 2016. The
increase in revenue from 2016 to 2017 were 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 in
2017. These increases were partially offset by lower grant
revenue from the FDA to support the clinical development of
avacopan for the treatment of patients with ANCA vasculitis.
Research and development expenses were $12.3 million for the
third quarter, compared to $8.4 million for the same period in
2016. The increase in research and development expenses from 2016
to 2017 was primarily attributable to the initiation and patient
enrollment of the avacopan Phase III ADVOCATE trial in patients
with ANCA vasculitis and start-up expenses for the Phase II
clinical trial of avacopan for the treatment of C3G. These
increases were partially offset by lower costs associated with the
completion of the avacopan CLEAR and CLASSIC Phase II clinical
trials for the treatment of ANCA vasculitis and enrollment
completion of the CCX872 Phase I trial in patients with advanced
pancreatic cancer in 2016.
General and administrative expenses were $3.6 million for the
third quarter, compared to $3.2 million for the same period in
2016. The increase from 2016 to 2017 was primarily due to
accounting related fees associated with preparing to meet the
requirements pursuant to the Sarbanes-Oxley Act of 2002.
Net losses for the third quarter were $6.6 million, compared to
$7.1 million for the same period in 2016.
Total shares outstanding at September 30, 2017 were
approximately 48.8 million shares.
The Company expects to utilize cash and cash equivalents in the
range of $50 million and $55 million in 2017, of which $39.0
million has been used for the nine months ended September 30,
2017.
Conference Call and Webcast
The Company will host a conference call and webcast today,
November 7, 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 7796287. 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 Commission 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 European Medicines Agency's
(EMA) 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 achievement of anticipated goals and
milestones, 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
Contacts:
Susan M.
Kanaya
Executive Vice President,
Chief Financial and Administrative
Officer
investor@chemocentryx.com
Media: Stephanie Tomei408.234.1279media@chemocentryx.com
Investors:Steve Klass, Burns
McClellan212.213.0006
sklass@burnsmc.com
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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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Nine Months
Ended |
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September
30, |
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September
30, |
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2017 |
|
2016 |
|
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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$ |
9,029 |
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$ |
4,131 |
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$ |
26,196 |
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$ |
6,751 |
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Grant
revenue |
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- |
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|
120 |
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- |
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295 |
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- |
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Total
revenue |
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|
9,029 |
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4,251 |
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26,196 |
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7,046 |
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Operating expenses: |
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Research
and development |
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12,315 |
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8,389 |
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36,614 |
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28,696 |
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General
and administrative |
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3,624 |
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|
3,193 |
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12,381 |
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11,154 |
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Total
operating expenses |
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15,939 |
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|
11,582 |
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|
48,995 |
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39,850 |
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Loss
from operations |
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|
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|
(6,910 |
) |
|
|
(7,331 |
) |
|
|
(22,799 |
) |
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|
(32,804 |
) |
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Interest income |
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|
350 |
|
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|
259 |
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|
1,003 |
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|
506 |
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Net loss |
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$ |
(6,560 |
) |
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$ |
(7,072 |
) |
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$ |
(21,796 |
) |
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$ |
(32,298 |
) |
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Basic and diluted net
loss per share |
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$ |
(0.13 |
) |
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$ |
(0.15 |
) |
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$ |
(0.45 |
) |
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$ |
(0.70 |
) |
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Shares
used to compute basic and diluted net loss per share |
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48,602 |
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|
47,763 |
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|
48,314 |
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45,942 |
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September
30, |
|
December
31, |
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2017 |
|
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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|
|
$ |
124,768 |
|
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$ |
123,761 |
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Accounts
receivable (1) |
|
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|
|
|
530 |
|
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|
30,205 |
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Working
capital |
|
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|
77,983 |
|
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|
110,356 |
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Total
assets |
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127,948 |
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155,872 |
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Accumulated deficit |
|
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|
|
|
(328,855 |
) |
|
|
(307,059 |
) |
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Total
stockholders’ equity |
|
|
|
|
|
37,297 |
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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. |
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