Clovis Oncology Retires Remaining 2021 Notes and Raises Additional Capital through its ATM Equity Offering Program
September 20 2021 - 8:00AM
Business Wire
Three Phase 3 topline Rubraca data readouts
expected in 2022
Initial data from LuMIERE study of targeted
radiotherapy candidate FAP-2286 also expected in 2022
Improved balance sheet complements ongoing
focus on cost control
Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that it has
paid off in full at maturity the remaining $64.4 million in
principal amount outstanding of its 2.50% convertible senior notes
due 2021. In addition, the Company provided an update on the
progress of its renewed “at-the-market” (ATM) equity offering
program announced in mid-August, pursuant to which it has sold
during the third quarter of 2021 to date an aggregate of
approximately 9.4 million shares of its common stock for gross
proceeds of approximately $43.0 million and resulting in net
proceeds to Clovis Oncology of approximately $41.7 million after
commissions and offering related expenses. This is in addition to
the previously announced approximately $72.5 million in net
proceeds raised by Clovis Oncology pursuant to its ATM equity
offering program during the second quarter of 2021.
“These activities improve our balance sheet and complement our
ongoing focus on cost control as we look forward to the potentially
transformative events of 2022,” said Patrick J. Mahaffy, President
and CEO of Clovis Oncology. “In 2022, we anticipate three Phase 3
data read-outs for Rubraca®, which offer the potential to
significantly expand the number of ovarian and prostate cancer
patients eligible for Rubraca treatment in the US and Europe. In
addition, we are enthusiastic about our ongoing Phase 1 LuMIERE
study of FAP-2286 in advanced solid tumors, and expect the
presentation of initial Phase 1 data at a medical meeting in 2022.
Each of these supports our three key strategies: expand the Rubraca
label to drive revenue growth, emerge as a leader in targeted
radionuclide therapy, and achieve long-term financial
stability.”
Three anticipated data readouts from Rubraca studies are
anticipated in 2022: ATHENA monotherapy in first-line maintenance
treatment ovarian cancer in Q1 2022, TRITON3 monotherapy in
second-line metastatic castration-resistant prostate cancer in Q2
2022, and ATHENA combination with Opdivo® in first-line maintenance
treatment ovarian cancer in 2H 2022. These data read-outs provide
the potential to reach larger patient populations in earlier lines
of therapy for ovarian and prostate cancers. The timing of each of
these read-outs is contingent upon the occurrence of the
protocol-specified progression-free survival events.
FAP-2286 is Clovis Oncology’s peptide-targeted radionuclide
therapy (PTRT) and imaging agent targeting fibroblast activation
protein (FAP) and is the lead candidate in the Company’s TRT
development program. The Phase 1 portion of the LuMIERE study is
evaluating the safety of the FAP-targeting investigational
therapeutic agent and will identify the recommended Phase 2 dose
and schedule of lutetium-177 labeled FAP-2286. FAP-2286 labeled
with gallium-68 will be used as an investigational imaging agent to
identify patients with FAP-positive tumors appropriate for
treatment in LuMIERE. The first presentation of Phase 1 data from
LuMIERE is expected at a medical meeting in 2022. Once the Phase 2
dose is determined, Phase 2 expansion cohorts are planned in
multiple tumor types and expected to initiate in 2022.
Sales of its common stock under the ATM equity offering program
were made by Clovis Oncology pursuant to a prospectus supplement
filed with the U.S. Securities and Exchange Commission. This press
release is for informational purposes only and is not an offer to
sell or the solicitation of an offer to buy any securities of
Clovis Oncology.
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, with partners, for
those indications that require them, diagnostic tools intended to
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado with additional office locations in the U.S. and
Europe.
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. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our business plans or prospects, our
expectations regarding our ability to maintain the enrollment and
conduct of our clinical trials and other development activities,
expectations concerning future regulatory activities, expectations
for submission of regulatory filings, our plans to present final or
interim data on ongoing clinical trials, our plans to submit
additional data to, or meet with, the FDA with respect to the
status of or plans for ongoing or planned trials, the timing and
pace of commencement of enrollment in and conduct of our clinical
trials and the cost of certain trials, including those being
considered, planned or conducted in collaboration with partners,
and our plans for commencement of additional planned trials and the
potential results of such clinical trials. Such forward-looking
statements involve substantial risks and uncertainties that could
cause our future results, performance, or achievements to differ
significantly from that expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
impacts of the COVID-19 pandemic and disruption related to efforts
to mitigate its spread on our business, results of operations or
financial condition, including impacts on our ability to continue
our development activities, impacts on the conduct of our clinical
trials, including with respect to enrollment rates, availability of
investigators and clinical trial sites or monitoring of data and
impact on the ability and timing of our field personnel to conduct
their activities with health care providers, the timing and extent
of recovery from the impact of COVID-19, whether our clinical
development programs for our drug candidates and those of our
partners can be completed on time or at all, whether future study
results will be consistent with study findings to date and whether
future study results will support continued development or
regulatory approval, the corresponding development pathways of our
companion diagnostics, the timing of availability of data from our
clinical trials and the results, the initiation, enrollment, timing
and results of our planned clinical trials, the risk that final
results of ongoing trials may differ from initial or interim
results as a result of factors such as final results from a larger
patient population may be different from initial or interim results
from a smaller patient population, actions by the FDA, the EMA or
other regulatory authorities regarding data required to support
drug applications and whether to accept or approve drug
applications that may be filed, their interpretations of our data
and agreement with our regulatory approval strategies or components
of our filings, including our clinical trial designs, conduct and
methodologies, as well as their decisions regarding drug labeling,
reimbursement and pricing, and other matters that could affect the
development, approval, availability or commercial potential of our
drug candidates or companion diagnostics. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210920005132/en/
Anna Sussman 303.625.5022 asussman@clovisoncology.com
Breanna Burkart 303.625.5023 bburkart@clovisoncology.com
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