ChemoCentryx Reports First Quarter 2021 Financial Results and Recent Highlights
April 29 2021 - 4:05PM
ChemoCentryx, Inc., (Nasdaq: CCXI), today announced financial
results for the first quarter ended March 31, 2021 and
provided an overview of recent corporate highlights.
"Momentum builds with each passing quarter,
bringing us closer to our goal of bringing novel, precisely
targeted medicine to those that need it most,” said Thomas J.
Schall, Ph.D., President and Chief Executive Officer of
ChemoCentryx. “At our R&D Day earlier this month, two
world-renowned clinicians outlined the unmet needs in
ANCA-associated vasculitis and the data driving their conviction
that avacopan could become a landscape-changing therapy. We are
well prepared and look forward to providing our views at the FDA
Advisory Committee meeting on this topic in just a few days. During
our R&D Day we also took the opportunity to establish how our
novel small molecule PD-1/PD-L1 inhibitor CCX559 could transcend
current limitations in the treatment of cancer. Meanwhile we are
progressing toward our next cycle of clinical trials: a Phase III
trial of avacopan in patients with severe HS; the initiation of
clinical development of avacopan in lupus nephritis, and our first
in human studies of the novel orally administered checkpoint
inhibitor CCX559 in cancer patients. We look forward to an historic
year of 2021 at ChemoCentryx, and we will devote all our energies
to making the dream of breakthrough new therapies a reality for
patients.”
Key First Quarter 2021 Highlights and
Recent Developments
- In April, the Company held an
R&D Day which focused on avacopan in ANCA-associated
vasculitis, with a patient describing his journey with the disease,
and the Company’s novel checkpoint inhibitor CCX559.
- Two leading clinical experts on
ANCA-associated vasculitis, Dr. Peter Merkel from the University of
Pennsylvania and Dr. David Jayne from the University of Cambridge,
explained in detail the widespread effects of this devastating
disease and the shortcomings of current therapy with
glucocorticoids and other immunosuppressive drugs. Drs.
Merkel and Jayne expressed their belief that avacopan could
transform the treatment landscape for ANCA-associated
vasculitis.
- The Company reported new data from
the ADVOCATE trial, covering an 8 week period immediately following
the 52-week endpoint. During this period from week 52 to week 60,
there were 6 relapses out of 158 in the avacopan group and 7
relapses out of 157 in the prednisone group, suggesting a waning of
efficacy after drug treatment is stopped. In addition, the
estimated Glomerular Filtration Rate (eGFR), which had increased in
the avacopan group through week 52, declined in the 8 weeks after
patients stopped taking avacopan.
- Tausif “Tosh” Butt, who joined the
Company in February 2021 as Executive Vice President and Chief
Operating Officer, summarized the Company’s preparations and
readiness for the anticipated commercial launch of avacopan shortly
after its PDUFA goal date. He reported on primary market research
that a survey of 125 rheumatologists and nephrologists indicated
that 97% would prescribe avacopan upon FDA approval. The Company
plans to focus initially on the estimated eight thousand patients
who are newly diagnosed or relapsing with organ or life-threatening
disease, out of an estimated eligible patient population for
avacopan of twenty thousand patients.
- CCX559 was featured in an abstract
at the 2021 Annual Meeting of the American Association for Cancer
Research (AACR) in April. The abstract highlighted laboratory and
in vivo data demonstrating potent PD-1/PD-L1 checkpoint inhibition.
As a next generation therapy, small molecule inhibitors of PD-L1
may have advantageous properties compared to approved monoclonal
antibodies, such as better penetration into solid tumors and
reduced immunogenicity. The Company plans to initiate Phase I
clinical development of CCX559 in Q2 2021.
- In February, The New England Journal
of Medicine (NEJM) published the results of the Company’s Phase III
ADVOCATE trial of avacopan in ANCA-associated vasculitis, in which
avacopan achieved statistical superiority in sustained remission at
52 weeks over prednisone containing standard of care. The same
issue of NEJM featured an editorial entitled “Avacopan – Time to
Replace Glucocorticoids?”.
- In February the Japanese New Drug
Application for avacopan in the treatment of ANCA-associated
vasculitis was accepted for review by the Pharmaceuticals and
Medical Devices Agency (PMDA), triggering a milestone payment of
$10 million to ChemoCentryx from its partner Vifor Pharma.
- The Company plans to advance
avacopan into Phase III development in patients with Hurley Stage
III (severe) HS in Q4 2021. In the Phase II AURORA trial, avacopan
demonstrated a statistically significant higher response than
placebo in Hurley Stage III patients.
- The Company plans to initiate
clinical development of avacopan in patients with lupus nephritis
in Q4 2021.
- The Company plans to schedule a
meeting with the FDA to discuss evidence of clinical benefit from
the ACCOLADE trial of avacopan in the very rare disorder C3
Glomerulopathy (C3G), for which there are no approved therapies. In
the trial, avacopan demonstrated statistically significant
improvement in renal function as measured by the pre-specified
endpoint of eGFR and in the pre-specified secondary endpoint of C3G
Histology Index (HI) Disease Chronicity score, compared to placebo
over 26 weeks of blinded treatment, but did not achieve a
statistically significant improvement in the primary endpoint of
the C3G HI Disease Activity Score. Avacopan was safe and well
tolerated in C3G patients.
- The Company maintained a strong
balance sheet, with reported cash, cash equivalents and investments
of $424.2 million at March 31, 2021.
First Quarter 2021 Financial
Results
Revenue was $10.4 million for the first quarter
of 2021, compared to $6.0 million for the same period in 2020. The
increase in revenue from 2020 to 2021 was principally attributable
to the $10.0 million milestone from Vifor for the February 2021
acceptance of the Japanese NDA for avacopan in the treatment of
ANCA vasculitis.
Research and development expenses were $23.4
million for the first quarter of 2021, compared to $19.3 million
for the same period in 2020. The increase from 2020 to 2021 was
primarily attributable to the manufacture of commercial drug supply
in anticipation of the launch of avacopan for the treatment of ANCA
vasculitis and costs associated with the advancement of CCX559, the
Company’s orally-available small molecule checkpoint (PD-1/PD-L1)
inhibitor. These increases were partially offset by
lower Phase II related expenses due to the completion of patient
enrollment of the avacopan AURORA Phase IIb clinical trial in
patients with HS and the discontinuation of further clinical
development of CCX140 in FSGS in 2020.
General and administrative expenses were $16.3
million for the first quarter of 2021, compared to $8.8 million for
the same period in 2020. The increase from 2020 to 2021 was
primarily due to higher employee-related expenses, including those
associated with the Company’s commercialization planning efforts,
and higher professional fees.
Net loss for the first quarter of 2021 was $29.7
million, compared to net loss of $21.7 million for the same period
in 2020.
Total shares outstanding at March 31, 2021 were
approximately 69.7 million shares.
Cash, cash equivalents and investments totaled
$424.2 million at March 31, 2021. The Company expects to utilize
cash, cash equivalents and investments in the range of $145
million to $155 million in 2021.
Conference Call and Webcast
The Company will host a conference call and
webcast today, April 29, 2021 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 3963565. 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 call.
About ChemoCentryx
ChemoCentryx is a biopharmaceutical company
developing new medications for inflammatory and autoimmune diseases
and cancer. ChemoCentryx targets the chemokine and
chemoattractant systems to discover, develop and commercialize
orally administered therapies. ChemoCentryx’s lead drug candidate,
avacopan (CCX168), successfully completed a pivotal Phase III trial
in ANCA-associated vasculitis and a New Drug Application is under
review by the U.S. Food and Drug Administration. Avacopan is also
in late stage clinical development for the treatment of severe
Hidradenitis Suppurativa and C3 glomerulopathy (C3G).
ChemoCentryx also has early stage drug
candidates that target chemoattractant receptors in other
inflammatory and autoimmune diseases and in cancer.
Forward-Looking
StatementsChemoCentryx 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 avacopan will be approved by the FDA, EMA or
PMDA for the treatment of ANCA-associated vasculitis, the timing of
the FDA’s, EMA’s and PMDA’s decision on the NDA, MAA, and JNDA,
respectively, the timing of the potential commercial launch of
avacopan in ANCA-associated vasculitis, whether avacopan will be an
effective treatment in other indications such as severe HS, C3G and
lupus nephritis, whether a Phase III trial of avacopan in patients
with severe HS will commence in Q4 2021, whether avacopan for lupus
nephritis and CCX559 will enter clinical trials in 2021 in Q4 2021
and Q2 2021, respectively, whether actual cash utilization will
fall within projections 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 1, 2021 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.
Contacts:Susan M.
KanayaExecutive Vice President,Chief Financial and Administrative
Officerinvestor@chemocentryx.com
Media:Stephanie
Tomei408.234.1279media@chemocentryx.com
Investors:Burns McClellanLee
Roth212.213.0006 lroth@burnsmc.com
ChemoCentryx, Inc. |
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Condensed Consolidated Financial Statements
Data |
|
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|
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(in thousands, except per share data) |
|
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|
|
|
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Three Months
Ended |
|
|
|
March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
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(unaudited) |
|
Condensed Consolidated Statements of Operations
Data: |
|
|
|
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Revenue: |
|
|
|
|
|
Collaboration and license revenue from related party |
|
$ |
10,223 |
|
|
$ |
5,855 |
|
|
Grant revenue |
|
|
130 |
|
|
|
153 |
|
|
Total revenue |
|
|
10,353 |
|
|
|
6,008 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
23,418 |
|
|
|
19,311 |
|
|
General and administrative |
|
|
16,262 |
|
|
|
8,820 |
|
|
Total operating expenses |
|
|
39,680 |
|
|
|
28,131 |
|
|
Loss from operations |
|
|
(29,327 |
) |
|
|
(22,123 |
) |
|
Other income (expense), net |
|
|
(384 |
) |
|
|
436 |
|
|
Net
loss |
|
$ |
(29,711 |
) |
|
$ |
(21,687 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.43 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per common
share |
|
|
69,608 |
|
|
|
61,295 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
2021 |
|
2020 |
|
|
|
(unaudited) |
|
|
|
Condensed Consolidated Balance Sheets Data: |
|
|
|
|
|
Cash, cash equivalents and investments |
|
$ |
424,159 |
|
|
$ |
460,370 |
|
|
Working
capital |
|
|
335,911 |
|
|
|
390,012 |
|
|
Total
assets |
|
|
499,112 |
|
|
|
518,899 |
|
|
Long-term
debt, net |
|
|
24,475 |
|
|
|
24,401 |
|
|
Accumulated
deficit |
|
|
(515,053 |
) |
|
|
(485,342 |
) |
|
Total stockholders’ equity |
|
|
361,004 |
|
|
|
385,613 |
|
|
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|
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