Clovis
Oncology, Inc. (NASDAQ:CLVS) today reported financial results for
its third quarter ended September 30, 2013, and provided an update for
its clinical
development programs.
“We are very pleased by the data recently presented for both CO-1686 and
rucaparib and the progress being made on both programs,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “Given the encouraging
results we’ve seen for CO-1686 to date, we look forward to identifying
the Phase 2 dose with our improved HBr formulation by the end of 2013,
and then commencing our initial registration study in the first half of
2014. This will be our first pivotal trial of a broad and global
clinical development plan for CO-1686.”
Third Quarter 2013 Financial Results
Clovis reported a net loss of $20.3 million for the third quarter of
2013, and $55.3 million for the first nine months of 2013. This compares
to a net loss of $18.3 million for the third quarter and $52.9 million
for the first nine months of 2012. Net loss attributable to common
stockholders for the third quarter of 2013 was $0.68 per share and $2.00
per share for the year to date, compared to $0.71 per share for the
third quarter and $2.15 per share for first nine months of 2012.
Research and development expenses totaled $16.1 million for the third
quarter and $44.0 million for first nine months of 2013, compared to
$15.5 million for the third quarter and $40.6 million for the first nine
months of 2012. The increase in research and development expenses over
the comparable periods in 2012 was driven by increased development
activities for both CO-1686 and rucaparib, partially offset by the
wind-down of development activities for CO-101 beginning in late 2012.
General and administrative expenses totaled $4.3 million for the third
quarter and $11.0 million for the first nine months of 2013, compared to
$2.8 million for the third quarter and $7.9 million for the first nine
months of 2012. The increase in general and administrative expenses over
the comparable periods in 2012 was primarily due to increased stock
compensation expense for employees engaged in general and administrative
functions and third party costs to support the Company’s expanded
activities.
Operating expenses for the third quarter of 2013 include $2.8 million of
stock compensation expense, compared to $1.5 million of stock
compensation expense for the third quarter of 2012. Operating expenses
for the first nine months of 2013 included $6.7 million of stock
compensation expense, compared to $3.6 million of stock compensation
expense for the first nine months of 2012.
As of September 30, 2013, Clovis had $356.6 million in cash and cash
equivalents and 30.2 million outstanding shares of common stock. The
Company used $47.9 million to fund operations for the nine months ended
September 20, 2013, and expects total cash burn for 2013 to be
approximately $66 million.
Progress Toward 2013 Key Milestones and Objectives
The Company has made significant progress toward its clinical,
regulatory and development objectives for 2013 for each of its key
products; descriptions of each product and highlights of recent progress
follow.
CO-1686
CO-1686 is a novel, oral, targeted, covalent inhibitor of the mutant
forms of the epidermal growth factor receptor (EGFR) in development for
the treatment of non-small cell lung cancer (NSCLC) and is currently in
the dose-escalation portion of a Phase 1 trial. CO-1686 was designed to
selectively target both the initial activating EGFR mutations as well as
the T790M resistance mutation, while sparing wild-type, or “normal” EGFR
at anticipated therapeutic doses.
Earlier this week, data from the ongoing CO-1686 Phase 1 dose-escalation
study were presented by Professor Jean-Charles Soria at the 15th
World Conference on Lung Cancer in Sydney. Six RECIST partial responses
(PR) have been observed to date in nine evaluable T790M positive
patients dosed at 900mg BID of the free base formulation, for a 67
percent objective response rate. Eight of the nine evaluable patients,
or 89 percent, experienced PRs or tumor shrinkage greater than 10
percent. These patients were heavily pretreated prior to receiving
CO-1686; eight of the nine patients had progressed on an EGFR TKI (e.g.
erlotinib) immediately prior to enrollment in the study. Six of the nine
patients received two or more previous TKI lines. Fifty-six
patients have been treated with CO-1686 to date across all dosing
cohorts, with no evidence of dose-related wild-type EGFR-driven
toxicities.
Enrollment in the ongoing Phase 1 study with the HBr formulation
commenced in late August, and pharmacokinetic (PK) and safety data from
this initial cohort were also presented earlier in the week in Sydney.
The HBr formulation at the 500mg BID dose demonstrated substantially
increased exposures over those seen with the free base formulation at
900mg BID. There has been no evidence of skin or gastrointestinal
toxicity in the 500mg BID cohort, and no dose limiting toxicity. Dose
escalation is ongoing with the HBr tablet formulation, currently dosing
at 750mg BID, as the maximum tolerated dose (MTD) has not yet been
reached.
Clovis expects to establish the Phase 2 dose by year-end 2013, and to
initiate the Phase 2expansion cohorts to assess efficacy in 2nd
line T790M+ NSCLC patients at that time and in 1st line EGFR
NSCLC patients in early 2014. The Company also expects to initiate its
Phase 1 study in Japan in early 2014.
In addition, based on the encouraging evidence of activity seen to date,
the Company now expects to commence the initial registration study in 2nd
line T790M+ NSCLC patients in the first half of 2014.
Rucaparib
Rucaparib is an oral, potent small molecule inhibitor of PARP1 and PARP2
being developed for the treatment of platinum sensitive, relapsed
ovarian cancer.
During the quarter, a dose of 600mg BID of rucaparib was selected as the
recommended Phase 2/3 dose based on exposure, manageable toxicity and
clinical activity. Safety data to date shows rucaparib to be
well-tolerated, which is important for a drug intended to be used in a
maintenance setting. Rucaparib demonstrates attractive PK properties as
a potential oral cancer therapeutic, including low inter-patient
variability and predictable plasma drug concentrations maintained over a
24-hour period with BID dosing. No patients have discontinued rucaparib
due to a treatment-related adverse event.
In data presented at recent medical meetings, rucaparib demonstrated
durable objective responses in heavily pre-treated patients. Data from
the Phase 1 dose-escalation study were presented in late September at
the European Cancer Congress 2013 in Amsterdam, and in mid-October at
the European Society of Gynecological Oncology international meeting in
Liverpool and at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics in Boston.
To date, eight RECIST responses have been observed during the Phase 1
study (measurable disease and/or elevated CA-125 was not required for
study entry). In ovarian cancer patients with a germline BRCA (gBRCA)
mutation, one RECIST complete response (CR), two RECIST partial
responses (PRs) and two GCIG CA-125 responses have been observed to
date. All of these patients are ongoing with maintained responses.
Responses have been observed in both platinum-sensitive and
platinum-resistant disease. Responses have also been achieved in breast
cancer and pancreatic cancer patients with a germline BRCA mutation.
Overall, 70% (7/10) of ovarian cancer patients with gBRCA mutations
treated with rucaparib at all doses achieved disease control as defined
by CR, PR, or stable disease (SD)>24 weeks.
Yesterday, the Company announced the enrollment of the first patient in
the global ARIEL2 (Assessment of Rucaparib in Ovarian Cancer Phase 2
Trial) study at a U.S. study site. ARIEL2 is a single-arm, open-label,
Phase 2 study designed to identify tumor characteristics that predict
sensitivity to rucaparib using DNA sequencing to evaluate each patient’s
tumor. Tumor samples from study participants will be studied for BRCA1
and BRCA2 mutations (genes that are linked to hereditary breast and
ovarian cancers), as well as other genes that are expected to confer
sensitivity to PARP inhibitor therapy when mutated.
In late 2013, the Company intends to initiate its pivotal study, ARIEL3,
a randomized, double-blind, Phase 3 study that will compare the effects
of rucaparib versus placebo. The study will evaluate whether maintenance
rucaparib in platinum-sensitive, ovarian, fallopian tube or primary
peritoneal high-grade cancer patients can extend the period of time for
which the disease is controlled after successful chemotherapy. The study
will utilize pre-specified efficacy analyses, first in BRCA-mutant
patients and then in patients with other DNA repair deficiencies
(defined by the outcome of the ARIEL2 study).
Conference Call Details
Clovis will hold a conference call to discuss third quarter 2013 results
this afternoon, October 31, at 4:30 p.m. ET. The conference call will be
simultaneously webcast on the Company’s web site at www.clovisoncology.com,
and archived for future review. Dial-in numbers for the conference call
are as follows: US participants 866-700-0133, International participants
617-213-8831, passcode: 70744190.
About
Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops diagnostic tools that direct a
compound in development to the population that is most likely to benefit
from its use. Clovis Oncology is headquartered in Boulder, Colorado, and
has additional offices in San Francisco, California and Cambridge, UK.
To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve substantial risks and uncertainties
that could cause our clinical development programs, future results,
performance or achievements to differ significantly from those expressed
or implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in the
initiation of future clinical trials, availability of data from ongoing
clinical trials, expectations for regulatory approvals, development
progress of our companion diagnostics, and other matters that could
affect the availability or commercial potential of our drug candidates
or companion diagnostics. Clovis Oncology undertakes no obligation to
update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the Company in
general, see Clovis Oncology’s Annual Report on Form 10-K for the year
ended December 31, 2012 and its other reports filed with the Securities
and Exchange Commission.
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CLOVIS ONCOLOGY, INC
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CONSOLIDATED FINANCIAL RESULTS
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(in thousands, except per share amounts)
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Three Months Ended September 30,
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Nine Months Ended September 30,
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2013
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2012
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2013
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2012
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Revenues
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$
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-
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$
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-
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$
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-
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$
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-
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Expenses:
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Research and development
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16,063
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15,458
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44,001
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40,610
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General and administrative
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4,312
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2,762
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11,022
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7,867
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Acquired in-process research and development
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-
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-
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|
250
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4,250
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Operating loss
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(20,375
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)
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(18,220
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)
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(55,273
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)
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(52,727
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)
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Other income (expense), net
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55
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(48
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)
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(56
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)
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(224
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)
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Loss before income taxes
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(20,320
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)
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(18,268
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)
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(55,329
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)
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|
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(52,951
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)
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|
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Income taxes
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|
-
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|
|
|
-
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|
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-
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27
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Net loss
|
|
$
|
(20,320
|
)
|
|
$
|
(18,268
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)
|
|
$
|
(55,329
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)
|
|
$
|
(52,924
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)
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Basic and diluted net loss per common share
|
|
$
|
(0.68
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)
|
|
$
|
(0.71
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)
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|
$
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(2.00
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)
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$
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(2.15
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)
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Basic and diluted weighted average common shares outstanding
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|
30,047
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|
25,906
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27,614
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|
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24,568
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CONSOLIDATED BALANCE SHEET DATA
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(in thousands)
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September 30, 2013
|
|
December 31, 2012
|
|
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Cash and cash equivalents
|
|
$
|
356,624
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|
|
$
|
144,097
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|
|
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|
Working capital
|
|
|
343,939
|
|
|
|
132,712
|
|
|
|
|
|
Total assets
|
|
|
360,259
|
|
|
|
145,994
|
|
|
|
|
|
Common stock and additional paid-in capital
|
|
|
585,273
|
|
|
|
317,925
|
|
|
|
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|
Total stockholders' equity
|
|
|
345,530
|
|
|
|
133,496
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Copyright Business Wire 2013