Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts

– Phase 1 dose-escalation trial follows filing of IND in December
2018 –

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced it is initiating phase 1
clinical development for XL092, the first internally-discovered Exelixis
compound to enter the clinic following the company’s reinitiation of
drug discovery activities. XL092 is a next-generation oral tyrosine
kinase inhibitor that targets VEGF receptors, MET, and other kinases
implicated in cancer’s growth and spread. The molecule is the subject of
an active Investigational New Drug (IND) application Exelixis submitted
to the U.S. Food and Drug Administration in December 2018.

“Exelixis is building a pipeline of diverse investigational medicines
behind cabozantinib through in-house drug discovery activities and
targeted in-licensing,” said Peter Lamb, Ph.D., Executive Vice President
of Scientific Strategy and Chief Scientific Officer of Exelixis. “XL092
is a novel compound that targets key signal transduction pathways in
tumors, while potentially addressing tumor-induced immune suppression.
Data from the upcoming phase 1 clinical trial will be used to determine
the potential for further development of XL092.”

The multi-center phase 1 clinical trial is designed to evaluate the
pharmacokinetics, safety and tolerability of XL092. The trial is divided
into dose-escalation and expansion phases. The dose-escalation phase of
the trial will enroll patients with advanced solid tumors, with the
primary objective of determining a dose for daily oral administration of
XL092 suitable for further evaluation. Assuming positive data from the
initial phase of the trial, the expansion phase is designed to further
explore the selected dose of XL092 in individual tumor cohorts, where
safety, tolerability, and initial clinical activity would be evaluated.

“Supported by revenues from the global cabozantinib franchise, Exelixis
is building on our prolific drug discovery history to advance a new
generation of Exelixis medicines,” said Michael M. Morrissey, Ph.D.,
President and Chief Executive Officer of Exelixis. “As the first
molecule to enter clinical development from our new laboratories here in
Alameda, XL092 represents an important milestone for our company and
highlights our commitment to the patients we serve. We look forward to
the clinical progress of XL092 and the continued maturation of other
earlier-stage molecules currently in development.”

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in model
genetic systems, we established a broad drug discovery and development
platform that has served as the foundation for our continued efforts to
bring new cancer therapies to patients in need. Our discovery efforts
have resulted in four approved products, CABOMETYX® (cabozantinib),
COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO™
(esaxerenone), and we have entered into partnerships with leading
pharmaceutical companies to bring these important medicines to patients
worldwide. Supported by revenues from our marketed products and
collaborations, we are committed to prudently reinvesting in our
business to maximize the potential of our pipeline. We are supplementing
our existing therapeutic assets with targeted business development
activities and internal drug discovery – all to deliver the next
generation of Exelixis medicines and help patients recover stronger and
live longer. Exelixis is a member of Standard & Poor’s (S&P) MidCap 400
index, which measures the performance of profitable mid-sized companies.
For more information about Exelixis, please visit www.exelixis.com,
follow @ExelixisInc on
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Inc.
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Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including,
without limitation, statements related to: the potential of XL092 to
address tumor-induced immunosuppression; Exelixis’ plan to use data from
the upcoming phase 1 clinical trial to determine the potential for
further development of XL092; Exelixis’ expectations for the clinical
progress of XL092 and continued maturation of other earlier-stage
molecules currently in development; and Exelixis’ plans to reinvest in
its business to maximize the potential of the company’s pipeline,
including through targeted business development activities and internal
drug discovery. Any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements and are based upon Exelixis’ current plans,
assumptions, beliefs, expectations, estimates and projections.
Forward-looking statements involve risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in the forward-looking statements as a result of these risks
and uncertainties, which include, without limitation: risks and
uncertainties related to regulatory review and approval processes and
Exelixis’ compliance with applicable legal and regulatory requirements;
the potential failure of XL092 to demonstrate safety and/or efficacy in
a phase 1 clinical trial and be deemed suitable for future evaluation;
uncertainties inherent in the drug discovery and product development
process, including evolving regulatory requirements, slower than
anticipated patient enrollment or inability to identify a sufficient
number of clinical trial sites; the costs of conducting clinical trials;
Exelixis’ dependence on third-party vendors for the development,
manufacture and supply of XL092; Exelixis’ ability to protect its
intellectual property rights; market competition; changes in economic
and business conditions; and other factors affecting Exelixis and its
development programs discussed under the caption “Risk Factors” in
Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 1, 2018, and in Exelixis’ future
filings with the SEC, including, without limitation, Exelixis’ Annual
Report on Form 10-K expected to be filed with the SEC on February 22,
2019. All forward-looking statements in this press release are based on
information available to Exelixis as of the date of this press release,
and Exelixis undertakes no obligation to update or revise any
forward-looking statements contained herein.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are
registered U.S. trademarks. MINNEBRO is a Japanese trademark.

Contacts

Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis,
Inc.

650-837-8194
shubbard@exelixis.com

Hal Mackins
For Exelixis, Inc.
415-994-0040
hal@torchcomllc.com

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