Clovis Oncology Announces 2013 Objectives and Financial Guidance

  Clovis Oncology Announces 2013 Objectives and Financial Guidance

Business Wire

BOULDER, Colo. -- January 7, 2013

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced anticipated development
milestones and financial guidance for 2013. Clovis currently has two clinical
development programs and one drug discovery program underway.


A novel, oral, mutant-selective covalent inhibitor of EGFR mutations in
non-small cell lung cancer (NSCLC), CO-1686 is currently the subject of an
accelerated second-line development program. Clovis anticipates completing the
following milestones in 2013 for CO-1686:

  *Complete dose escalation portion of Phase I/II study to establish the dose
    and schedule;
  *Initiate expansion cohorts of Phase I/II study to assess efficacy in
    second-line T790M+ NSCLC patients and in first-line mutant EGFR NSCLC;
  *Initiate use of Roche Molecular Systems diagnostic test to identify T790M+
    patients; and
  *Prepare to initiate pivotal study in second-line T790M+ NSCLC patients in
    the first half of 2014.


An oral inhibitor of PARP-1 and PARP-2, rucaparib is being explored in ovarian
and breast cancer patients with BRCA mutations and other DNA repair
deficiencies. Clovis anticipates completing the following milestones in 2013
for rucaparib:

  *Complete dose escalation portion of Phase I/II study to identify the
    monotherapy dose and schedule;
  *Initiate expansion cohort of Phase I/II study to assess efficacy in
    selected ovarian cancer patients;
  *Initiate Phase II biomarker validation in selected ovarian cancer patients
    to correlate clinical responses with patient genotype and inform the
    analysis of the pivotal trial;
  *Advance development of diagnostic test with Foundation Medicine to
    identify patients with BRCA mutations and other DNA repair deficiencies
    most likely to respond to rucaparib;
  *Initiate pivotal study of rucaparib as maintenance therapy in selected
    platinum-sensitive ovarian cancer patients in the second half of 2013.

Mutant c-KIT inhibitor discovery program

During 2012, Clovis entered into a collaboration with Array BioPharma Inc. to
discover a novel KIT inhibitor targeting the resistance mutations that occur
in the majority of gastrointestinal stromal tumor patients and result in
disease progression. This collaboration will continue in 2013 with a goal of
identifying a lead compound in late 2013 or early 2014.

Year-End 2012 Cash Position and 2013 Financial Guidance

Clovis ended 2012 with approximately $144.0 million in cash (these results are
preliminary and unaudited), which should provide sufficient resources to
demonstrate meaningful evidence of efficacy for CO-1686 and rucaparib. Clovis
expects a cash burn of $53.0 to $57.0 million for 2013, ending the year with
approximately $90.0 million in cash.

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.

Forward Looking Statements

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 or discovery 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 our clinical development programs for
CO-1686 and rucaparib, our discovery program for the mutant cKIT inhibitor,
the corresponding development pathways of our companion diagnostics, actions
by the FDA, the EMA or other regulatory authorities regarding whether to
approve drug applications that may be filed, as well as their decisions
regarding drug labeling, and other matters that could affect the availability
or commercial potential of our drug candidates or companion diagnostics,
including competitive developments. Clovis Oncology does not undertake to
update or revise any forward-looking statements. A further description of
risks and uncertainties can be found in Clovis Oncology’s in its reports on
Form 10-Q and Form 8-K.


Clovis Oncology
Anna Sussman, 303-625-5022
Breanna Burkart, 303-625-5023
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