-- Phase III clinical trial of avacopan for the
treatment of ANCA Vasculitis underway as Journal of American
Society of Nephrology (JASN) publishes results of successful Phase
II CLEAR clinical trial --
ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company
developing new medications targeted at inflammatory and autoimmune
diseases and cancer, today announced financial results for the
first quarter ended March 31, 2017.
“We end the first quarter of 2017 with a strengthened balance
sheet thanks to our expanded kidney health alliance with Vifor
Pharma and also with our Phase III trial for avacopan in ANCA
Vasculitis (AAV) underway,” said Thomas J. Schall, Ph.D., President
and Chief Executive Officer of ChemoCentryx. “We are pleased to
have received a third orphan drug designation for avacopan from the
FDA, adding C3 glomerulopathy to the previous orphan designations
for AAV and atypical hemolytic uremic syndrome (aHUS). By the end
of this year, we plan to have four late stage clinical trials in
rare renal indications in progress, each of which, if successful,
may support registration; one for each of avacopan’s three orphan
indications, and one for CCX140 in the treatment of focal segmental
glomulerosclerosis.”
Recent Highlights
- In April 2017, the Journal of the American Society of
Nephrology (JASN) published the clinical results from the Company’s
Phase II CLEAR trial, which demonstrated that avacopan provides
rapid and effective control of AAV while eliminating the need for
chronic high doses of steroids, which are associated with
significant safety issues. AAV is an autoimmune disease that
destroys blood vessels and can lead to renal failure. The ADVOCATE
Phase III trial of avacopan in AAV is now underway, a randomized,
double-blind two arm multi-center study enrolling 300
patients.
- In March 2017, ChemoCentryx announced that the U.S. Food and
Drug Administration (FDA) granted orphan drug designation for
avacopan for the treatment of patients with C3 glomerulopathy
(C3G), a disease in which deposits of proteins from the body’s
complement system disrupt kidney function and trigger a destructive
inflammation of the kidney. There is currently no approved
treatment for C3G and relapse is common even after kidney
transplant. This is the third disease area for which avacopan has
been granted U.S. orphan-drug designation, highlighting its
potential to help patients with rare renal diseases. The Company is
in discussion with the FDA and the European Medicines Agency (EMA)
on the design of a clinical trial, which could lead to submission
for regulatory approvals.
- In February 2017, ChemoCentryx announced an expanded agreement
with Vifor Pharma that provides Vifor the rights to commercialize
avacopan for orphan and rare renal diseases in all international
markets except China, while ChemoCentryx retains the rights to
commercialize avacopan in the United States. This agreement
harmonizes the international rights for avacopan with those in the
agreement signed with Vifor in December 2016 for the Company’s late
stage drug candidate CCX140 in the treatment of focal segmental
glomerulosclerosis (FSGS). FSGS is a disease for which no
FDA-approved treatment exists, and which if left untreated leads to
end stage renal disease. The $20 million upfront commitment to
ChemoCentryx under the latest agreement brings the total of upfront
cash payments and commitments from Vifor Pharma to $155 million, as
well as milestone payments and tiered double-digit royalties on
potential net sales.
First Quarter 2017 Financial Results
Pro forma cash, cash equivalents, investments and remaining
upfront commitments totaled $179.7 million at March 31, 2017.
Revenue was $8.2 million for the first quarter, compared to zero
for the same period in 2016.
Research and development (R&D) expenses were $10.0 million
for the first quarter, compared to $11.2 million for the same
period in 2016.
General and administrative (G&A) expenses were $4.6 million
for the first quarter, compared to $4.1 million for the same period
in 2016.
Net losses for the first quarter were $6.0 million, compared to
$15.2 million for the same period in 2016.
Total shares outstanding at March 31, 2017 were approximately
48.2 million shares.
The Company expects to utilize cash and cash equivalents between
$50 million and $55 million in 2017.
Conference Call and Webcast
The Company will host a conference call and webcast today, May
10, 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 13584608.
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). 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, the timing of potential clinical trials and regulatory
submissions, whether the Company's alliance with Vifor Pharma will
provide milestone payments and royalties on international sales,
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. |
|
|
|
Consolidated
Statement of Operations Data |
|
|
|
(in thousands,
except per share data) |
|
|
|
|
|
|
|
|
Three Months
Ended |
|
March
31, |
|
2017 |
|
2016 |
Consolidated Statement of Operations
Data: |
|
|
|
|
|
|
|
Revenue: |
|
|
|
Collaboration and license revenue |
$ |
8,230 |
|
|
$ |
- |
|
Total
revenue |
|
8,230 |
|
|
|
- |
|
|
|
|
|
Operating expenses: |
|
|
|
Research
and development |
|
9,970 |
|
|
|
11,245 |
|
General
and administrative |
|
4,573 |
|
|
|
4,084 |
|
Total
operating expenses |
|
14,543 |
|
|
|
15,329 |
|
Loss
from operations |
|
(6,313 |
) |
|
|
(15,329 |
) |
|
|
|
|
Interest income |
|
317 |
|
|
|
86 |
|
Net loss |
$ |
(5,996 |
) |
|
$ |
(15,243 |
) |
|
|
|
|
Basic and diluted net
loss per share |
$ |
(0.12 |
) |
|
$ |
(0.34 |
) |
|
|
|
|
Shares
used to compute basic and diluted |
|
48,115 |
|
|
|
44,277 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
(in
thousands) |
Consolidated Balance Sheet
Data |
|
|
|
Cash,
cash equivalents and investments (1) |
$ |
149,650 |
|
|
$ |
123,761 |
|
Accounts
receivable (1) |
|
- |
|
|
|
30,205 |
|
Working
capital |
|
77,354 |
|
|
|
110,356 |
|
Total
assets |
|
152,371 |
|
|
|
155,872 |
|
Accumulated deficit |
|
(313,055 |
) |
|
|
(307,059 |
) |
Total
stockholders’ equity |
|
46,322 |
|
|
|
49,889 |
|
|
|
|
|
|
|
|
|
(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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