Clovis Oncology Announces First Quarter 2013 Operating Results

  Clovis Oncology Announces First Quarter 2013 Operating Results

Business Wire

BOULDER, Colo. -- 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 2^nd line T790M+ NSCLC patients by
late 2013 and in 1^st line EGFR NSCLC patients by early 2014, and to initiate
the registration study in 2^nd 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 December31, 2012 and its other reports filed
with the Securities and Exchange Commission.

                                                                             
CLOVIS ONCOLOGY, INC
CONSOLIDATED FINANCIAL RESULTS
(in thousands, except per share amounts)
                                                      
                                        Three Months Ended March 31,
                                        2013             2012
                                                                             
Revenues                                $  -               $   -
                                                                             
Expenses:
Research and development                   12,122              12,562
General and administrative                 3,218               2,425
Acquired in-process research and          250             4,000     
development
Operating loss                            (15,590  )       (18,987   )
                                                                             
Other income (expense), net               (78      )       (4        )
Loss before income taxes                  (15,668  )       (18,991   )
                                                                             
Income taxes                              -               (8        )
Net loss                                $  (15,668  )    $   (18,999   )
                                                                             
Basic and diluted net loss per          $  (0.60    )      $   (0.86     )
common share
                                                                             
Basic and diluted weighted average         26,034              22,041
common shares outstanding
                                                                             
                                                                             
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
                                                                             
                                        March 31, 2013   December 31, 2012
                                                                             
Cash and cash equivalents               $  129,634         $   144,097
Working capital                            118,902             132,712
Total assets                               131,497             145,994
Common stock and additional paid-in        319,843             317,925
capital
Total stockholders' equity                 119,737             133,496

Contact:

Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
 
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