- Rucaparib rolling NDA submission
initiated for treatment of patients with advanced ovarian cancer
with deleterious BRCA mutated tumors and expected to complete Q2
2016
- Rucaparib MAA submission planned Q4
2016
- Clovis preparing for potential U.S.
commercial launch of rucaparib with existing commercial
infrastructure in Q4 2016 or Q1 2017
- ARIEL3 pivotal rucaparib maintenance
study target enrollment completed
- Clovis entered into a clinical trial
collaboration to evaluate a novel combination therapy of
atezolizumab (MPDL3280A; anti-PDL1) and rucaparib for the treatment
of gynecological cancers
- Complete Response Letter (CRL) for
rociletinib anticipated on or before June 28 PDUFA date
- Clovis has withdrawn its Marketing
Authorization Application of rociletinib with European regulatory
authorities
- Clovis has terminated enrollment in all
ongoing sponsored studies of rociletinib, including TIGER-3
- $445.5 million in cash, cash
equivalents and available-for-sale securities at the end of Q1
2016; Company anticipates ending 2016 with approximately $220-$235M
in cash, cash equivalents and available-for-sale securities
- Clovis has sufficient cash to fund
operations into 2018
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for its quarter ended March 31, 2016, and provided an update on the
Company’s clinical development programs and regulatory outlook for
the remainder of 2016.
“We are very disappointed in the outcome for rociletinib, as
there is a need for additional options for this difficult to treat
disease,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “Our focus moving forward is clear: prioritize rucaparib
development activity and prepare for its potential U.S. launch, and
manage our existing cash into 2018.”
First Quarter 2016 Financial Results
Clovis had $445.5 million in cash, cash equivalents and
available-for-sale securities as of March 31, 2016. Cash used in
operating activities was $83.7 million for the first quarter of
2016, compared with $48.4 million in the first quarter of 2015.
Clovis had approximately 38.4 million outstanding shares of common
stock as of March 31, 2016.
Clovis reported a net loss for the first quarter of 2016 of
$83.4 million, or ($2.17) per share, compared to a net loss of
$63.1 million, or ($1.86) per share, for the first quarter of 2015.
Net loss for the first quarter of 2016 included share-based
compensation expense of $11.0 million compared to $8.7 million for
the first quarter of 2015.
Research and development expenses totaled $74.6 million for the
first quarter of 2016, compared to $56.8 million for the first
quarter 2015. The year-over-year increase in expenses is due to the
significantly expanded clinical development activities for
rucaparib, increased commercial product planning costs and
increased personnel-related expenses associated with the hiring of
additional staff including the U.S. sales force to support the
Company’s expanded activities, partially offset by lower expenses
related to clinical development activities for rociletinib.
General and administrative expenses totaled $9.8 million for the
first quarter of 2016, compared to $6.8 million for the first
quarter 2015. The increase year over year is primarily due to
higher legal expense, consulting fees and personnel costs for
employees engaged in general and administrative activities.
The Company expects cash used in operating activities for 2016
will total approximately $294 - $309 million, and to end the year
with approximately $220 - $235 million in cash, cash equivalents
and available-for-sale securities. Clovis anticipates being able to
continue to fund operations into 2018 from currently available
cash, cash equivalents and available-for-sale securities.
2016 Key Milestones and Objectives
Highlights of planned or completed objectives for each product
follow:
Rucaparib
During the second quarter of 2016, Clovis commenced the
submission of its rolling New Drug Application (NDA) regulatory
filing to the U.S. Food and Drug Administration (FDA) for rucaparib
for the monotherapy treatment of patients with advanced ovarian
cancer with deleterious BRCA-mutated tumors (inclusive of both
germline and somatic BRCA mutations) previously treated with
multiple prior therapies. Rucaparib was granted Breakthrough
Therapy designation by the FDA in April 2015. Clovis agreed with
the FDA that the submission would be a rolling NDA and has filed
the first component for potential accelerated approval of rucaparib
in the U.S. The rolling NDA allows completed portions of an NDA to
be submitted and reviewed by the FDA on an ongoing basis. The
Company intends to complete the NDA submission by the end of the
second quarter of 2016.
Foundation Medicine, Clovis’ companion diagnostic partner,
intends to file a Premarket approval application (PMA) of its
diagnostic assay designed to identify both germline and somatic
BRCA mutations with the FDA. The timing of the submission is
expected to allow for regulatory approval of the companion
diagnostic at substantially the same time that rucaparib would be
approved.
In addition, the Company intends to submit its Marketing
Authorization Application (MAA) for rucaparib to the European
Medicines Agency for a comparable ovarian cancer treatment
indication in Q4 2016.
We have completed target enrollment in the ARIEL3 pivotal
maintenance study, with data expected to be available in
approximately 12 months. Pending positive data, Clovis intends to
follow up with supplemental NDAs for maintenance indications in
tumor BRCA mutant patients and BRCA-like patients.
Clovis recently entered into a clinical trial collaboration with
Genentech, a member of the Roche Group, to evaluate a novel
combination therapy of Genentech’s investigational cancer
immunotherapy atezolizumab (MPDL3280A; anti-PDL1) and rucaparib for
the treatment of gynecological cancers, with a focus on ovarian
cancer. The Phase 1b trial is planned to begin enrolling patients
during the second half of 2016.
Also during the second half of 2016, the Company intends to
initiate a study of rucaparib in metastatic castrate-resistant BRCA
mutant (inclusive of germline and somatic) prostate cancer
patients, as well as the ARIEL4 confirmatory study in advanced
ovarian cancer.
Rociletinib
In a recent meeting with the FDA, Clovis was notified that it
could anticipate receiving a Complete Response Letter (CRL) for the
rociletinib NDA on or before the PDUFA date of June 28, 2016. The
FDA issues a CRL to indicate that their review of an application is
complete and that the application is not ready for approval. In
anticipation of receiving the CRL, Clovis has terminated enrollment
in all ongoing sponsored clinical studies of rociletinib. Clovis
will continue to provide drug to patients whose clinicians
recommend continuing rociletinib therapy. In addition, Clovis has
withdrawn its MAA for rociletinib previously filed with European
regulatory authorities. Related to terminating enrollment in all
ongoing sponsored clinical studies of rociletinib, Clovis is
reducing its staff, eliminating contractor positions and delaying
or eliminating planned new positions. This will result in the
reduction of our staff and contractor positions by 35 percent by
the end of 2016, compared to year-end 2015.
However, we intend to maintain the U.S. sales force in
preparation for the potential U.S. launch of rucaparib. Clovis has
determined there would be effectively no cost savings in
eliminating the U.S. sales force and replacing it with a contract
organization to support the potential U.S. launch of rucaparib in
Q4 2016 or Q1 2017. In addition, a decision to use a contract sales
organization could potentially delay the timing of the U.S.
launch.
Lucitanib
Enrollment was completed during the first quarter in the ongoing
Phase 2 study exploring lucitanib in patients with
treatment-refractory breast cancer. In parallel with Clovis’
sponsored study, a Servier-sponsored Phase 2 study of lucitanib in
patients with advanced breast cancer is underway to identify the
population of patients most likely to benefit from lucitanib
therapy. The Company expects to make a decision regarding the
future development of lucitanib by the end of 2016.
Conference Call Details
Clovis will hold a conference call to discuss first quarter 2016
results this afternoon, May 5, at 4:30pm 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
866.489.9022, International participants 678.509.7575, conference
ID: 2018033.
About Rucaparib
Rucaparib is an oral, potent small molecule inhibitor of PARP1-3
being developed for the treatment of ovarian cancer, specifically
in patients with tumors with BRCA mutations and other DNA repair
deficiencies beyond BRCA, including those with high genomic loss of
heterozygosity (LOH) commonly referred to as “BRCA-like." Clovis is
also exploring rucaparib in other solid tumor types with
significant BRCA and BRCA-like populations, including prostate,
breast and gastroesophageal cancers. Rucaparib was granted
Breakthrough Therapy designation by the U.S. FDA in April 2015.
Clovis holds worldwide rights for rucaparib.
About Rociletinib
Rociletinib is an oral, mutant-selective inhibitor of epidermal
growth factor receptor (EGFR). Rociletinib targets the activating
mutations of EGFR (L858R and Del19), while also inhibiting the
dominant acquired resistance mutation, T790M. Clovis holds
worldwide rights for rociletinib.
About Lucitanib
Lucitanib is an oral, potent inhibitor of the tyrosine kinase
activity of vascular endothelial growth factor receptors 1 through
3 (VEGFR1-3), platelet-derived growth factor receptors alpha and
beta (PDGFRα-β) and fibroblast growth factor receptors 1 through 3
(FGFR1-3). Clovis, which holds exclusive U.S. and Japanese rights,
is collaborating with its development partner Les Laboratoires
Servier (Servier) on the global clinical development of lucitanib
outside of China, initially targeting advanced breast cancer.
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.
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 our clinical development programs for our
drug candidates, 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 filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
CLOVIS ONCOLOGY, INC CONSOLIDATED FINANCIAL
RESULTS (in thousands, except per share amounts)
Three Months Ended March 31, 2016
2015 Revenues: License and milestone revenue $
- $ - Operating expenses: Research and development 74,608
56,750 General and administrative 9,827 6,751 Accretion of
contingent purchase consideration 516 724
Total expenses 84,951 64,225
Operating loss (84,951 ) (64,225 ) Other income
(expense): Interest expense (2,104 ) (2,075 ) Foreign currency
gains (losses) (551 ) 3,247 Other income (expense) 25
11 Other income (expense), net (2,630 )
1,183 Loss before income taxes (87,581 ) (63,042 )
Income tax expense 4,181 (102 ) Net loss $
(83,400 ) $ (63,144 ) Basic and diluted net loss per common
share $ (2.17 ) $ (1.86 ) Basic and diluted weighted-average
common shares outstanding 38,360 34,011
CONSOLIDATED BALANCE SHEET DATA (in thousands) March
31, 2016 December 31, 2015 Cash and cash
equivalents $ 220,373 $ 278,756 Available-for-sale securities
225,117 249,832 Working capital 390,030 464,125 Total assets
644,574 713,386 Convertible senior notes 280,192 279,885 Common
stock and additional paid-in capital 1,141,686 1,130,016 Total
stockholders' equity 232,663 300,650
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160505006474/en/
Clovis Oncology, Inc.Breanna Burkart,
303-625-5023bburkart@clovisoncology.comorAnna Sussman,
303-625-5022asussman@clovisoncology.com
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