On May 2, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported 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 (Press release, Exelixis, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346478 [SID1234525962]). 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.

On May 2, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP), reported that management will host a conference call and webcast slide presentation on Thursday, May 10, at 4:30 p.m. ET to provide a corporate update and discuss financial results for the first quarter ended March 31, 2018 (Press release, Ziopharm, MAY 2, 2018, View Source [SID1234525979]).

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The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 4857096. To access the slides and live webcast or the subsequent archived recording, visit the "Investors & Media" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

On May 2, 2018 The Mundipharma global network of independent associated companies reported that Herzuma, biosimilar trastuzumab, is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months (Press release, Mundipharma, MAY 2, 2018, View Source [SID1234526137]). The Mundipharma network has exclusive distribution rights to Herzuma in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.

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Richard Trollope, Head of Oncology and Biosimilars at Mundipharma International Limited, said: "Building on our partnership with Celltrion Healthcare, we are pleased to announce that biosimilar trastuzumab is now available in Europe with national launches commencing in both the UK and Germany. The availability of biosimilar trastuzumab will provide an alternative treatment option to the thousands of eligible patients across Europe with early breast cancer, metastatic breast cancer or metastatic gastric cancer."

Herzuma, a biosimilar of i.v. Herceptin, was granted marketing authorisation on 9th February 2018 for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer whose tumours have either HER2 overexpression or HER2 gene amplification, following positive opinion and recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2017. Biosimilar trastuzumab has the potential to make significant cost savings for healthcare organisations, releasing healthcare resource for other innovative medicines.3

Alberto Martinez, President and CEO, Mundipharma International Limited, said: "Mundipharma has a proven track record of launching biosimilars successfully in Europe, which is illustrated by Celltrion Healthcare entrusting us once again with the launch of biosimilar trastuzumab across key European markets. As biosimilar trastuzumab continues to launch in additional countries, we look forward to assisting healthcare economies across Europe wanting to deliver better value to patients."

Herzuma is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe, having launched Remsima (infliximab), the first biosimilar monoclonal antibody, in 2015, and Truxima (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in 2017.

On May 2, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the U.S. Patent and Trademark Office (USPTO) has issued a new patent protecting the company’s lead product candidate, tipifarnib (Press release, Kura Oncology, MAY 2, 2018, View Source [SID1234525943]).

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U.S. patent 9,956,215, "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors," includes multiple claims directed to the use of tipifarnib as a method of treating patients with CXCL12-expressing peripheral T-cell lymphoma (PTCL) or acute myeloid leukemia (AML). The newly issued patent has an expiration date of November 2037, excluding any possible patent term extension. Kura continues to pursue U.S. and foreign patent protection in these and other indications.

"We are excited by the potential opportunity for tipifarnib in hematologic malignancies, and this new patent represents an important milestone in our development plan," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "In addition, the issuance of this patent comes less than one year after the USPTO issued a similar patent for tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC), reinforcing the potential of our broader strategy to generate intellectual property related to the use of our drug candidates in genetically defined patient populations."

"Although tipifarnib has been known to be clinically active in hematologic malignancies for over a decade, a precise molecular mechanism of action was never elucidated and few if any clinical trials using genetic selection were conducted," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "At Kura, we discovered that the CXCL12 pathway is a potential target for tipifarnib, and markers of CXCL12 pathway activation may provide methods to select or stratify patients who are most likely to benefit from tipifarnib therapy."

In December 2017, Kura presented new findings at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that identified activation of the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of tipifarnib’s activity in certain hematologic malignancies, including PTCL, AML, myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Based on these observations, the company is now working to prospectively validate these potential biomarkers in its ongoing Phase 2 trials of tipifarnib in hematologic malignancies. Kura expects biomarker-enriched data from these ongoing Phase 2 trials in the second half of 2018.

About Tipifarnib

Tipifarnib is a potent, selective and orally bioavailable inhibitor of the enzyme farnesyl transferase. Tipifarnib was previously studied in more than 5,000 cancer patients and demonstrated compelling and durable anti-cancer activity in certain patients with a manageable side effect profile. Following a positive Phase 2 trial in HRAS mutant HNSCC and a successful end of Phase 2 meeting with the FDA, Kura is planning to conduct a global, registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC. The trial, called AIM-HN, is expected to initiate in the second half of 2018.

On May 2, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2018 and provided an update on progress toward fulfilling its key corporate objectives, as well as commercial and clinical development milestones (Press release, Exelixis, MAY 2, 2018, View Source [SID1234525963]).

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"In the first quarter of 2018, Exelixis continued to make significant progress in the ongoing commercialization of CABOMETYX (cabozantinib) for advanced renal cell carcinoma. Following FDA approval for its expanded indication in advanced first-line renal cell carcinoma, our team immediately began promoting CABOMETYX across all lines of therapy for this patient population, resulting in further uptake from prescribers at both major academic institutions and in the community setting," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "The resulting growth in U.S. sales, as well as the increasing collaboration revenues from our various partners, were important contributors to our strong financial performance during the quarter, leading to net income of $115.9 million or $0.37 per share on a fully diluted basis."

Dr. Morrissey continued: "From its initial approval for a rare disease indication five years ago, cabozantinib has grown to become an oncology franchise with the potential for global impact. We and our collaboration partners are committed to maximizing its opportunity to help patients across multiple tumor types. This now includes our recent regulatory submissions for previously treated advanced hepatocellular carcinoma, an aggressive cancer with worldwide relevance. Our efforts in liver cancer, as well as our plans to start additional phase 3 trials in other forms of cancer later this year, are each reflective of the Exelixis corporate mission to help patients with cancer recover stronger and live longer."

First Quarter 2018 Financial Results
Total revenues for the quarter ended March 31, 2018 were $212.3 million, compared to $80.9 million for the comparable period in 2017.

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and Provides Corporate Update May 2, 2018

Total revenues include net product revenues of $134.3 million for the quarter ended March 31, 2018, compared to $68.9 million for the comparable period in 2017. The increase in net product revenues reflects the growth of our second and later-line advanced renal cell carcinoma (RCC) business and the impact of additional sales following the U.S. Food and Drug Administration’s (FDA) approval in December 2017 of the expanded indication for CABOMETYX, which now encompass all patients with advanced RCC.
Total revenues also include collaboration revenues of $78.1 million for the quarter ended March 31, 2018 compared to $12.0 million for the comparable period in 2017. The increase in collaboration revenues for the quarter ended March 31, 2018 was primarily the result of recording $45.8 million in revenue for a $50.0 million milestone from Ipsen Pharma SAS (Ipsen) we expect to earn in the second quarter of 2018 for the approval of cabozantinib for the first-line treatment of advanced RCC by the European Commission (EC). The determination to recognize the $45.8 million in revenue was made following the Committee for Medicinal Products for Human Use’s (CHMP) positive opinion of cabozantinib for the first-line treatment of advanced RCC. The increase in collaboration revenues was also a result of a $20.0 million milestone from our collaboration partner Daiichi Sankyo Company, Limited (Daiichi Sankyo), which was earned as a result of Daiichi Sankyo’s submission of a regulatory application to the Japanese Pharmaceutical and Medical Devices Agency for esaxerenone (CS-3150) as a treatment for patients with essential hypertension. These increases were partially offset by a decrease in the recognition of deferred revenue due to our adoption of Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606) on January 1, 2018. As a result, $258.5 million was recorded in stockholders’ equity relating primarily to a reduction in the remaining unrecognized upfront and non-substantive milestone payments that had been received from our collaboration partners and was included in deferred revenue at December 31, 2017. For more information on our adoption of the new revenue standard, see "Note 1. Organization and Summary of Significant Accounting Policies – Revenue" contained in Part I, Item 1 of Exelixis’ Quarterly Report on Form 10-Q expected to be filed with the Securities and Exchange Commission (SEC) on May 2, 2018.
Research and development expenses for the quarter ended March 31, 2018 were $37.8 million, compared to $23.2 million for the comparable period in 2017. The increase in research and development expenses was primarily related to an increase in personnel-related expenses resulting from an increase in headcount in support of our development and discovery efforts and an increase in clinical trial costs. Clinical trial costs increased primarily due to start-up costs associated with CheckMate 9ER, an ongoing phase 3 pivotal trial of cabozantinib plus immunotherapy in patients with previously untreated RCC that is being conducted with Bristol-Myers Squibb Company, and start-up costs associated with our phase 1b trial of cabozantinib and atezolizumab in locally advanced or metastatic solid tumors; those increases were partially offset by decreases in costs related to METEOR, our completed phase 3 pivotal trial comparing CABOMETYX to everolimus in patients with advanced RCC. Research and development expenses for the quarter ended March 31, 2018 also included a $3.0 million upfront payment for our exclusive collaboration and license agreement with StemSynergy Therapeutics, Inc. (StemSynergy).
Selling, general and administrative expenses for the quarter ended March 31, 2018 were $52.6 million, compared to $34.3 million for the comparable period in 2017. The increase in selling, general and administrative expenses was primarily a result of increases in corporate giving, personnel expenses and marketing activities. The increase in personnel expense resulted from an increase in general and administrative headcount to support the company’s commercial and research and development organizations.
Net income for the quarter ended March 31, 2018 was $115.9 million, or $0.39 per share, basic and $0.37 per share, diluted, compared to a $16.7 million, or $0.06 per share, basic and $0.05 per share diluted, for the comparable period in 2017. The increase in net income was primarily the result of increases in net

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and Provides Corporate Update May 2, 2018

product revenues and collaboration revenues, which was partially offset by the increases in research and development and selling, general and administrative expenses.
Cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments totaled $525.6 million at March 31, 2018, as compared to $457.2 million at December 31, 2017.
2018 Financial Guidance
The company is maintaining its guidance that total costs and operating expenses for the full year will be between $430 million and $460 million. This guidance includes approximately $50 million of non-cash costs and expenses related primarily to stock-based compensation expense.
Cabozantinib Highlights
Strong Growth in Cabozantinib Franchise Net Revenues. Cabozantinib generated $134.3 million in net product revenues during the first quarter of 2018, an increase of 95 percent year-over-year. During the first quarter of 2018, CABOMETYX generated $128.9 million in net product revenues and COMETRIQ (cabozantinib) capsules for the treatment of patients with progressive, metastatic medullary thyroid cancer generated an additional $5.3 million in net product revenues.
Amendment to Clinical Research Protocol for Phase 1b Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors. In January, Exelixis announced an amendment to the protocol for the phase 1b trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The amendment added four new expansion cohorts to the trial, which now includes patients with non-small cell lung cancer and castration-resistant prostate cancer, in addition to previously included patients with RCC and urothelial carcinoma (UC). The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.
Cabozantinib Data at the ASCO (Free ASCO Whitepaper) 2018 Genitourinary Cancers Symposium (ASCO-GU). In February, cabozantinib was the subject of 14 presentations at the 2018 ASCO (Free ASCO Whitepaper)-GU Symposium in San Francisco. Updated results from the ongoing phase 1 trial of cabozantinib in combination with nivolumab, with or without ipilimumab, in patients with refractory genitourinary tumors were the subject of a poster presentation, with the two combination regimens demonstrating an acceptable tolerability profile, and high rates of durable responses in the previously treated metastatic UC and metastatic RCC cohorts. This phase 1 trial informed the design of CheckMate 9ER.
Cabozantinib Data at the 2018 Multidisciplinary Head and Neck Cancers Symposium. Also in February, cabozantinib was the subject of an oral presentation at this medical meeting held in Scottsdale, Arizona. Investigators presented results from the ongoing investigator-sponsored phase 2 trial of cabozantinib in patients with radioiodine-refractory differentiated thyroid carcinoma (DTC) in the first-line setting. Based on these results and data from other studies of cabozantinib in previously treated DTC, Exelixis plans to initiate a pivotal phase 3 study with cabozantinib in patients with advanced DTC later this year.
Submission of Supplemental New Drug Application (sNDA) for CABOMETYX as a Treatment for Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC). In March, Exelixis announced it had completed the submission of its sNDA to the FDA for CABOMETYX as a treatment for patients with previously treated advanced HCC. The sNDA submission is based on results from the CELESTIAL randomized pivotal phase 3 trial, data from which were presented in January at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium (ASCO-GI). At ASCO (Free ASCO Whitepaper)-GI, Exelixis and Ipsen hosted a live briefing event

Exelixis Announces First Quarter 2018 Financial Results Page 4 of 8
and Provides Corporate Update May 2, 2018

for the financial community to discuss cabozantinib data presented at the conference. The replay of the briefing is available on the News & Events / Event Calendar page at www.exelixis.com.
European Medicines Agency (EMA) Validation of the Application for a New Indication for CABOMETYX for Previously Treated Advanced HCC. Also in March, Exelixis’ partner Ipsen announced its application for variation to the CABOMETYX marketing authorization had been validated by the EMA for the addition of a new indication for patients with previously treated advanced HCC. Upon the acceptance of this filing, Exelixis will receive a $10.0 million milestone payment per the terms of the company’s collaboration agreement with Ipsen.
CABOMETYX Receives Positive CHMP Opinion for Previously Untreated Intermediate- or Poor-Risk Advanced RCC. In March, Exelixis’ partner Ipsen received a positive opinion from the CHMP, the scientific committee of the EMA, for CABOMETYX for the first-line treatment of adults with intermediate- or poor-risk advanced RCC. The positive CHMP opinion is being reviewed by the EC, which has the authority to approve medicines for the European Union.
Cobimetinib Highlights
Phase 1b Results for the Combination of Cobimetinib and Atezolizumab in Metastatic Colorectal Cancer (CRC) at ASCO (Free ASCO Whitepaper)-GI. In January, updated safety and efficacy results from the phase 1b clinical trial sponsored by Genentech, Inc. (a member of the Roche Group) (Genentech) evaluating cobimetinib in combination with atezolizumab in patients with metastatic CRC were presented at ASCO (Free ASCO Whitepaper)-GI. Initial results reported from this study presented at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting led to the initiation of IMblaze370 (formerly COTEZO), a phase 3 pivotal trial evaluating both the combination of cobimetinib and atezolizumab and atezolizumab alone versus regorafenib in patients with unresectable locally advanced or metastatic CRC, for which Genentech has guided it expects top-line results in the first half of 2018.
IMspire150 TRILOGY Trial Reaches Full Enrollment. The Roche Group recently confirmed that IMspire150 TRILOGY, its phase 3 pivotal trial evaluating the combination of cobimetinib, atezolizumab and vemurafenib in patients with first-line BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma, completed enrollment. The trial began enrolling patients in January 2017.
Corporate Highlights
Exclusive Licensing Agreement with StemSynergy for the Discovery and Development of Novel Anticancer Therapies. In January, Exelixis announced it had entered into an exclusive collaboration and license agreement with StemSynergy for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha, a component of the Wnt signaling pathway implicated in key oncogenic processes.
Daiichi Sankyo’s Submission of Regulatory Filing for Esaxerenone (CS-3150) in Japan. In February, Exelixis announced its partner Daiichi Sankyo submitted its regulatory application for esaxerenone as a treatment for patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency. The application was based on the results of phase 3 studies including ESAX-HTN, a randomized, double-blind, three-arm parallel group comparison study evaluating the efficacy and safety of esaxerenone versus eplerenone in patients with essential hypertension in Japan. As a result of the submission, Exelixis received a $20.0 million milestone payment in March 2018 per the collaboration agreement.
Election of Dr. Maria Freire to Exelixis’ Board of Directors. In April, Exelixis announced the election of biomedical research executive Maria C. Freire, Ph.D. to the company’s Board of Directors. Dr. Freire currently serves as President and Executive Director and as a member of the board of directors of the Foundation for the National Institutes of Health, an independent 501(c)(3) charitable organization established by

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Congress to support the National Institutes of Health by raising private funds for biomedical research and fostering partnerships and alliances around the world.
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended March 30, 2018, December 29, 2017 and March 31, 2017 are indicated as being as of and for the periods ended March 31, 2018, December 31, 2017 and March 31, 2017, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the first quarter of 2018 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Wednesday, May 2, 2018.
To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 7895176 to join by phone.
A telephone replay will be available until 8:30 p.m. EDT on May 4, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 7895176. A webcast replay will also be archived on www.exelixis.com for one year.