BOULDER, Colo.--(BUSINESS WIRE)--May. 7, 2013--
Clovis
Oncology, Inc. (NASDAQ:CLVS) today reported financial results for
its first quarter ended March 31, 2013, and provided an update for its clinical
development programs. This update describes, for the first time, the
Company’s progress in developing a new formulation for CO-1686,
including results from a recently initiated pharmacokinetic (PK) study
in healthy human volunteers.
“During the first quarter, we made important progress in our clinical
development programs,” said Patrick J. Mahaffy, president and CEO of
Clovis Oncology. “We have now established that our tablet formulation of
CO-1686, using a hydrobromide salt form of the drug, demonstrates much
higher plasma exposure levels and substantially reduced variability in
humans, compared with our current capsule formulation. As a result, we
are pleased to transition our development of CO-1686, including dose
escalation in the ongoing Phase I study, to this improved formulation
beginning in the next few months. For rucaparib, we are nearing the end
of the Phase I portion of the monotherapy study, and we are looking
forward to initiating our biomarker study in the third quarter of 2013
as well as our pivotal trial in late 2013. And, in particular, we look
forward to sharing initial Phase I study results for both CO-1686 and
rucaparib at the American Society of Clinical Oncology (ASCO) medical
conference in early June.”
First Quarter 2013 Financial Results
Clovis reported a net loss of $15.7 million for the first quarter of
2013 compared to a net loss of $19.0 million for the first quarter of
2012. Net loss attributable to common stockholders for the first quarter
of 2013 was $0.60 per share, compared to $0.86 per share for the first
quarter of 2012. The decrease in the net loss for the first quarter of
2013 is due primarily to $4.0 million of acquired in-process research
and development expenses recorded in the first quarter of 2012,
associated with the achievement of a CO-1686 development milestone.
Research and development expenses totaled $12.1 million for the first
quarter of 2013, compared to $12.6 million for the first quarter of
2012. General and administrative expenses totaled $3.2 million for the
first quarter of 2013, compared to $2.4 million for the first quarter of
2012; this increase is due primarily to larger share-based compensation
expenses in the first quarter of 2013. Operating expenses for the first
quarter of 2013 include total share-based compensation expense of $1.8
million, compared to $0.9 million for the first quarter of 2012.
As of March 31, 2013, Clovis had $129.6 million in cash and cash
equivalents and 26.2 million outstanding shares of common stock. The
Company updated its cash burn guidance for 2013 and now expects to burn
between $60 to $65 million for the year, and to end 2013 with
approximately $82 million in cash. The reason for the increase in case
burn guidance for 2013 is the acceleration of clinical trial and drug
supply costs from 2014 into 2013 as the Company advances its clinical
development programs for CO-1686 and rucaparib.
Progress Toward 2013 Key Milestones and Objectives
The Company has a number of important clinical, regulatory and
development objectives planned for 2013 for each of its key products;
highlights of progress made during the first quarter 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 I/II trial. During the first
quarter, Clovis initiated a study of CO-1686 in healthy human
volunteers, comparing the pharmacokinetic properties of its tablet
formulation with the current capsule formulation. Based on data
collected to date, the tablet formulation has demonstrated plasma
exposures approximately three-fold greater than the capsule formulation,
dose-for-dose, as well as greatly reduced PK variability. These data
suggest that the tablet formulation can be administered at significantly
lower oral doses to achieve higher and more predictable exposures in
patients, compared with the current capsule formulation.
Based on these data, the Company now plans to transition to the tablet
formulation for all CO-1686 clinical studies beginning in the third
quarter of 2013. Until then, the Phase I dose escalation study will
continue to enroll new patients with the capsule formulation at the
current dose of 900 mg BID. Since the maximum tolerated dose (MTD) has
not yet been achieved, Clovis will continue dose escalation in this
study when the tablet formulation is available. The Company currently
expects that the dose escalation with the tablet will begin at a dose of
approximately 300 mg BID, which relates to the exposures seen at 900 mg
BID with the capsule.
Clovis now expects to achieve the Phase II dose and initiate the Phase
II expansion cohorts to assess efficacy in 2nd line T790M+
NSCLC patients by late 2013 and in 1st line EGFR NSCLC
patients by early 2014, and to initiate the registration study in 2nd
line T790M+ NSCLC patients in the second half of 2014. The Company also
plans to initiate a Phase I study of the tablet formulation in Japan in
early 2014.
Data from the CO-1686 Phase I dose-escalation study have been accepted
as a poster discussion at ASCO, at which time a more comprehensive
update of data from the study will be provided.
Rucaparib
Rucaparib is an oral, potent inhibitor of PARP-1 and PARP-2 in
development for the treatment of ovarian cancer. During the first
quarter, the Company advanced the dose-escalation portion of the Phase
I/II study to establish the rucaparib monotherapy dose and schedule. The
Phase I portion of the study is now dosing patients at 480 mg BID, and
the Company believes that it is nearing the end of the Phase I portion
of the study. Upon identification of the recommended Phase II
monotherapy dose and schedule, Clovis will initiate the Phase II
expansion cohort to assess efficacy in selected ovarian cancer patients.
The Company continues to expect to initiate the biomarker study in
platinum-sensitive ovarian cancer patients in the third quarter of 2013,
as well as the pivotal study in platinum-sensitive ovarian cancer
patients in late 2013.
Data from the rucaparib Phase I dose-escalation study, as well as data
from the Phase I study of rucaparib in combination with carboplatin,
have been accepted as poster presentations at ASCO in early June, at
which time a more comprehensive update of data from the studies will be
provided.
Clovis will hold a conference call to discuss first quarter 2013 results
this morning, May 7, at 8:30 a.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 866.363.8009, International participants
617.597.5342, passcode: 90689352.
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 March 31,
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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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Expenses:
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Research and development
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12,122
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12,562
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General and administrative
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3,218
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2,425
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Acquired in-process research and development
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250
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4,000
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Operating loss
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(15,590
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)
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(18,987
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)
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Other income (expense), net
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(78
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)
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(4
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)
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Loss before income taxes
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(15,668
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)
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(18,991
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)
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Income taxes
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-
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(8
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)
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Net loss
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$
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(15,668
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)
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$
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(18,999
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)
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Basic and diluted net loss per common share
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$
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(0.60
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)
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$
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(0.86
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)
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Basic and diluted weighted average common shares outstanding
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26,034
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22,041
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CONSOLIDATED BALANCE SHEET DATA
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(in thousands)
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March 31, 2013
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December 31, 2012
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Cash and cash equivalents
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$
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129,634
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$
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144,097
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Working capital
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118,902
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132,712
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Total assets
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131,497
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145,994
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Common stock and additional paid-in capital
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319,843
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317,925
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Total stockholders' equity
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|
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119,737
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133,496
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Source: Clovis Oncology, Inc.
Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com