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Exelixis and Invenra Enter Into Collaboration to Discover and Develop Novel Biologics to Treat Cancer

– Companies will partner to advance multispecific antibodies in up to seven discrete projects, including one program against an undisclosed target currently in lead selection –

– Exelixis’ expansion into biologics builds upon history of success in the discovery, development and commercialization of small molecule drugs –

SOUTH SAN FRANCISCO, Calif. & MADISON, Wis.--(BUSINESS WIRE)--May 2, 2018-- Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a collaboration with Invenra, Inc., the Madison, Wisconsin-based biotechnology firm focused on developing next-generation biologics, to discover and develop multispecific antibodies for the treatment of cancer. The partnership pairs Exelixis’ fundamental biological insights, clinical development prowess and commercialization expertise with Invenra’s innovative platform technologies and biologics expertise to identify, optimize, and manufacture multispecific therapeutics, including immunotherapy applications. The collaboration is part of Exelixis’ ongoing strategy to build an innovative pipeline beyond its two internally discovered, commercially available compounds, cabozantinib and cobimetinib. The agreement with Invenra creates a biologics discovery capability that complements Exelixis’ in-house small molecule drug discovery efforts.

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Under the terms of the agreement, Exelixis and Invenra will collaborate to discover and develop multispecific antibodies through the use of Invenra’s B-Body™ technology platform, which enables high-throughput discovery, functional screening, and in vitro and in vivo preclinical characterization of promising therapeutic candidates. Invenra will be responsible for antibody lead discovery and generation. Exelixis will lead investigational new drug (IND)-enabling studies, manufacturing, clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities.

“Partnering with Invenra to leverage its deep expertise in protein engineering and the discovery of multispecific antibodies is an important step toward adding proprietary biologics to the Exelixis pipeline,” said Peter Lamb, Ph.D., Executive Vice President, Discovery Research and Chief Scientific Officer of Exelixis.” We are excited to work with the Invenra team and have structured our collaboration to provide relatively small financial support upfront and pay for success down the road. As we rebuild our internal small molecule discovery capability, this partnership provides a complementary approach that enables us to target pathways not accessible to small molecules, increasing our ability to advance novel therapies into the clinic.”

Under the collaboration agreement, Exelixis will receive an exclusive, worldwide license to one preclinical asset, and Exelixis and Invenra intend to pursue up to six additional discovery projects during the term of the collaboration, which in total are directed to three discovery programs. In consideration for the exclusive worldwide license and other rights contained in the collaboration agreement, Exelixis will pay Invenra an upfront payment of $2.0 million plus $2.0 million at initiation of each discovery project. Invenra is eligible to receive payments of up to $131.5 million based on the achievement of specific pre-clinical, clinical development and regulatory milestones for any product containing a lead preclinical asset in the first indication. Upon successful commercialization of a product, Invenra is eligible to receive global milestone payments up to $325 million, if certain sales thresholds are achieved as well as single digit tiered royalties on net sales of the approved product.

“We’re very excited to partner with Exelixis on this multi-asset collaboration as the company moves beyond its small molecule expertise to build a biologics pipeline,” said Roland Green, Ph.D., Chief Executive Officer and Co-Founder of Invenra. “Invenra’s B-Body™ platform has been validated internally. Our innovative technologies to discover, characterize, and generate multispecific antibodies pair well with Exelixis’ demonstrated success in oncology clinical development and commercialization. We look forward to working together with the Exelixis team to bring forward potential new anti-cancer therapies.”

About Invenra

Invenra, Inc., is a biotechnology company focused on the discovery and development of multispecific antibodies for immuno-oncology. Invenra’s proprietary B-Body™ and SNIPER™ technologies are used to develop novel antibodies that can bind to two or more specific therapeutic targets and mimic the natural IgG antibodies made by the human body. The B-Body™ platform enables the rapid identification of an optimal combination of epitope, affinity and geometry of an antibody using high throughput in-format screening for function in cell-based assays, while maintaining the biophysical characteristics needed for lead development. Importantly, the B-Body™ platform is designed to create advantages for candidate discovery with novel mechanisms of action and ease of manufacturing. Invenra has developed its own pipeline of lead multispecific antibodies and has partnered with several biotechnology and pharmaceutical companies who leverage Invenra’s technologies to identify molecules with biological relevance for drug development. For more information, please visit www.invenra.com.

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. We discovered our lead compounds, cabozantinib and cobimetinib, and advanced them into clinical development before entering into partnerships with leading biopharmaceutical companies in our efforts to bring them to patients globally. We are steadfast in our commitment to prudently reinvest in our business to maximize the potential of our pipeline. We intend to supplement 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 recently earned a spot on Deloitte’s Technology Fast 500 list, a yearly award program honoring the 500 fastest-growing companies over the past four years. For more information about Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter.

Forward-Looking Statement Disclaimer

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ strategy to build an innovative pipeline beyond cabozantinib and cobimetinib; Exelixis’ plan to add proprietary biologics to its pipeline and the importance of the Invenra partnership to that plan; the potential for the Invenra partnership to increase Exelixis’ ability to advance novel therapies into the clinic; Exelixis’ and Invenra’s intent to pursue up to six additional discovery projects during the term of the collaboration; Exelixis’ immediate and potential future financial obligations under the collaboration and license agreement with Invenra; the potential of the Exelixis-Invenra partnership to bring forward potential new anti-cancer therapies; Exelixis’ commitment to reinvesting in its business to maximize the potential of its pipeline, including through targeted business development activities and internal drug discovery; and Exelixis’ mission to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Words such as “will,” “strategy,” “intend,” “look forward,” “focused,” “potential,” “may,” “commitment,” or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements 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: the inherent uncertainty of the drug discovery process; Exelixis’ dependence on its relationships with its collaboration partners, including, the level of their investment in the resources necessary to successfully develop and commercialize products subject to the collaboration; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis’ ability and the ability of its collaborators to conduct preclinical studies and clinical trials of the products in its pipeline sufficient to achieve a positive completion; risks related to the potential failure of the products in Exelixis’ pipeline to demonstrate safety and efficacy in clinical testing; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; market acceptance of CABOMETYX, COMETRIQ, and COTELLIC and the availability of coverage and reimbursement for these products; competition in the area of business development activities; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of its products; Exelixis’ ability to protect the company’s intellectual property rights; market competition; changes in economic and business conditions, and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and in Exelixis’ future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Exelixis, the Exelixis logo and Invenra are registered U.S. trademarks.

Source: Exelixis, Inc.

For Exelixis:
Investors Contact:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
EVP, Public Affairs and Investor Relations
shubbard@exelixis.com
or
Media Contact:
For Exelixis, Inc.
Hal Mackins, 415-994-0040
hal@torchcommunications.com
or
For Invenra:
Angela Bitting, 925-202-6211
media@invenra.com