Clovis Oncology Announces Second Quarter 2013 Operating Results

  Clovis Oncology Announces Second Quarter 2013 Operating Results

 ● Encouraging initial data for both CO-1686 and rucaparib presented at ASCO

               ● Dose established for rucaparib pivotal program

   ● Clinical transition to CO-1686 tablet formulation on track for August

   ● Additional Phase I data updates for CO-1686 and rucaparib expected at
                     medical conferences later this year

Business Wire

BOULDER, Colo. -- August 1, 2013

Clovis Oncology, Inc. (NASDAQ:CLVS) today reported financial results for its
second quarter ended June 30, 2013, and provided an update for its clinical
development programs, including initial data presented at the American Society
of Clinical Oncology (ASCO) Annual Meeting 2013.

“During the second quarter, we were pleased to announce at ASCO encouraging
initial responses in patients in the Phase I portions of our clinical
development programs for CO-1686 and rucaparib. Importantly, each of the
patients who achieved a partial response on CO-1686 continues on therapy and
has maintained their response,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “We have now selected a dose for rucaparib for use in the
Phase II and Phase III trials planned for later this year, and for CO-1686, we
have identified a starting dose for the hydrobromide salt tablet formulation,
which we plan to introduce later this month into our Phase I trial in lung
cancer patients. We are maintaining our momentum, and we look forward to
providing updates for both of these programs at medical conferences this
fall.”

Second Quarter 2013 Financial Results

Clovis reported a net loss of $19.3 million for the second quarter of 2013,
and $35.0 million for the first half of 2013. This compares to a net loss of
$15.7 million for the second quarter and $34.7 million for the first six
months of 2012. Net loss attributable to common stockholders for the second
quarter of 2013 was $0.72 per share and $1.33 per share for the year to date,
compared to $0.61 per share for the second quarter and $1.45 per share for
first six months of 2012.

Research and development expenses totaled $15.8 million for the second quarter
and $27.9 million for first half of 2013, compared to $12.6 million for the
second quarter and $25.2 million for the first six 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, and the initiation of the cKIT inhibitor discovery collaboration
with Array Biosciences, Inc. in July 2012. These increases were partially
offset by the wind-down of development activities for CO-101 beginning in late
2012.

General and administrative expenses totaled $3.5 million for the second
quarter and $6.7 million for the first six months of 2013, compared to $2.7
million for the second quarter and $5.1 million for the first six months of
2012. The increase in general and administrative expenses over the comparable
periods in 2012 was primarily due to increased internal resources and third
party costs to support the Company’s expanded development activities and
increased stock compensation expense for employees engaged in general and
administrative functions.

Operating expenses for the second quarter of 2013 include $2.1 million of
stock compensation expense, compared to $1.2 million of stock compensation
expense for the second quarter of 2012. Operating expenses for the first half
of 2013 included $3.9 million of stock compensation expense, compared to $2.1
million of stock compensation expense for the first half of 2012.

As of June 30, 2013, Clovis had $372.2 million in cash and cash equivalents
and 30.2 million outstanding shares of common stock. In June 2013, the Company
raised net proceeds of $259.1 million through a public offering of 3.8 million
shares of its common stock. The Company expects a cash burn of approximately
$65 million for 2013, and to end the year with approximately $340 million in
cash.

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 second 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. 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.

During the second quarter, Clovis reported initial findings from the
dose-escalation portion of the Phase I/II trial at ASCO. These results
included the following:

  *Four RECIST partial responses (PRs) observed in heavily-pretreated T790M+
    patients
  *Three of four evaluable T790M+ patients treated at 900mg twice daily (BID)
    achieved PRs
  *CO-1686 appeared to be well tolerated, with no evidence of wild-type EGFR
    inhibition
  *Activity correlated with higher drug exposure
  *Phase II dose not yet defined; maximum tolerated dose (MTD) not yet
    reached

All four of the patients with RECIST PRs announced at ASCO continue to be PRs.
The Company has enrolled 11 additional patients into the Phase I dose
escalation study with the capsule formulation at the current dose of 900mg
BID, and intends to enroll two additional patients in early August, for a
total of 19 patients enrolled at this dose, including both T790M positive and
T790M negative patients. Since the MTD has not yet been achieved, Clovis
intends to continue dose escalation in this study with the hydrobromide salt
(HBr) tablet formulation later this month.

During the second quarter, the Company completed its study of CO-1686 in
healthy human volunteers, which compared the pharmacokinetic (PK) properties
of its tablet formulation with the current capsule formulation and
demonstrated improved exposures and reduced variability with the tablet
formulation. Based on data from this study, the Company has selected a
starting dose of 500mg BID with the tablet formulation and expects to begin
dosing patients with this tablet later this month.

Clovis continues to expect to establish the Phase II dose in the second half
of 2013, and to initiate the Phase II expansion cohorts to assess efficacy in
2^nd line T790M+ NSCLC patients in late 2013 and in 1^st line EGFR NSCLC
patients in early 2014. The Company expects to initiate the registration study
in 2^nd line T790M+ NSCLC patients in the second half of 2014 and a Phase I
study in Japan in early 2014.

Data from the CO-1686 Phase I dose-escalation study have been accepted as an
oral presentation at the 15^th World Conference on Lung Cancer in Sydney,
Australia, at which time data from the ongoing study will be presented. The
oral presentation will be held on Monday, October 28, 2013.

Rucaparib

Rucaparib is an oral, potent inhibitor of PARP-1 and PARP-2 in development for
the treatment of ovarian cancer and is currently in a dose-finding Phase I
trial.

In early June, Clovis reported initial findings from the dose-finding Phase I
trial at ASCO. These results included the following:

  *Objective responses were observed in BRCA-mutant ovarian, breast and
    pancreatic cancer patients
  *89 percent clinical benefit rate in BRCA-mutant ovarian cancer patients
    across all doses
  *Rucaparib appears to be well-tolerated at doses studied
  *Consistent therapeutic drug exposures were observed with BID dosing, with
    predictable exposures for a given oral dose

Each of the patients who achieved a PR and was active on study at ASCO has
maintained their PR.

The Company recently established the rucaparib monotherapy dose and schedule
for use in its upcoming Phase II and Phase III studies. Based on data from the
dose-finding Phase I study, the Company has selected a dose of 600mg BID.
Clovis expects to initiate the Phase II biomarker study to assess efficacy in
selected ovarian cancer patients, known as ARIEL2 (Assessment of Rucaparib in
Ovarian Cancer Phase II Trial), in the fourth quarter, and to initiate the
pivotal study, ARIEL3 (Assessment of Rucaparib in Ovarian Cancer Phase III
Trial), in platinum-sensitive ovarian cancer patients in late 2013 as well.

Data from the rucaparib Phase I dose-finding study have been accepted as a
poster presentation at the European Cancer Congress 2013 in Amsterdam, at
which time data from the ongoing study will be presented. The poster
presentation will be held on Sunday, September 29, 2013.

Clovis will hold a conference call to discuss second quarter 2013 results this
morning, August 1, 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 877.703.6105, International participants 857.244.7304, passcode:
92379365.

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, 2013 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 June 30,     Six Months Ended June
                                                   30,
                   2013          2012            2013          2012
                                                                   
Revenues           $ -             $ -             $ -             $ -
                                                                   
Expenses:
Research and         15,816          12,590          27,938          25,152
development
General and          3,492           2,680           6,710           5,105
administrative
Acquired
in-process          -           250           250         4,250   
research and
development
Operating loss      (19,308 )    (15,520 )      (34,898 )    (34,507 )
                                                                   
Other income        (33     )    (172    )      (111    )    (176    )
(expense), net
Loss before         (19,341 )    (15,692 )      (35,009 )    (34,683 )
income taxes
                                                                   
Income taxes        -           35            -           27      
Net loss           $ (19,341 )   $ (15,657 )     $ (35,009 )   $ (34,656 )
                                                                   
Basic and
diluted net        $ (0.72   )     $ (0.61   )     $ (1.33   )     $ (1.45   )
loss per
common share
                                                                   
Basic and
diluted
weighted             26,717          25,744          26,377          23,892
average common
shares
outstanding
                                                                   
                                                                   
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
                                                                   
                   June 30,      December
                   2013            31, 2012
                                                                   
Cash and cash      $ 372,240       $ 144,097
equivalents
Working              361,431         132,712
capital
Total assets         375,224         145,994
Common stock
and additional       582,445         317,925
paid-in
capital
Total
stockholders'        363,001         133,496
equity

Contact:

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