Clovis Oncology Announces Third Quarter 2013 Operating Results

  Clovis Oncology Announces Third Quarter 2013 Operating Results

  *CO-1686 and rucaparib demonstrated meaningful clinical activity in data
    presented at recent medical meetings
  *67 percent objective response rate demonstrated in heavily pretreated
    T790M+ NSCLC patients dosed at 900mg BID free base form of CO-1686
  *Dose escalation continues with improved hydrobromide (HBr) formulation
  *First patient enrolled in ARIEL2 Phase II study of rucaparib in ovarian
    cancer
  *Pivotal ARIEL3 study of rucaparib to commence by YE 2013
  *Initial CO-1686 registration study to commence H1 2014

Business Wire

BOULDER, Colo. -- October 31, 2013

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 15^th 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 2^nd line T790M+ NSCLC
patients at that time and in 1^st 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 2^nd 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 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 September      Nine Months Ended
                  30,                               September 30,
                  2013            2012             2013          2012
                                                                   
Revenues          $  -             $  -             $  -           $ -
                                                                   
Expenses:
Research and         16,063           15,458           44,001        40,610
development
General and          4,312            2,762            11,022        7,867
administrative
Acquired
in-process          -             -              250        4,250   
research and
development
Operating loss      (20,375  )     (18,220  )      (55,273 )   (52,727 )
                                                                   
Other income        55            (48      )      (56     )   (224    )
(expense), net
Loss before         (20,320  )     (18,268  )      (55,329 )   (52,951 )
income taxes
                                                                   
Income taxes        -             -              -          27      
Net loss          $  (20,320  )   $  (18,268  )    $  (55,329 )  $ (52,924 )
                                                                   
Basic and
diluted net       $  (0.68    )    $  (0.71    )    $  (2.00   )   $ (2.15   )
loss per common
share
                                                                   
Basic and
diluted
weighted             30,047           25,906           27,614        24,568
average common
shares
outstanding
                                                                   
                                                                   
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
                                                                   
                  September 30,   December 31,
                  2013             2012
                                                                   
Cash and cash     $  356,624       $  144,097
equivalents
Working capital      343,939          132,712
Total assets         360,259          145,994
Common stock
and additional       585,273          317,925
paid-in capital
Total
stockholders'        345,530          133,496
equity
                                                                   

Contact:

Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
 
Press spacebar to pause and continue. Press esc to stop.