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ZIOPHARM Reports Fourth-Quarter 2015 Financial Results and Provides Update on Recent Activities

On February 24, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported financial results for the fourth quarter ended December 31, 2015, and provided an update on the Company’s recent activities (Press release, Ziopharm, FEB 24, 2016, View Source [SID:1234509180]).

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"We look forward to a number of important milestones throughout 2016 across our gene and cell therapy platforms," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "For our lead gene therapy, Ad-RTS-IL-12 + veledimex, this includes data presentations in the first half of the year from our Phase 1 brain cancer trial, our Phase 1/2 breast cancer trial and from a translational, preclinical study demonstrating powerful antitumor effects when combining with checkpoint inhibitors. Through the balance of 2016, we expect to initiate or continue prosecuting up to six proof-of-concept generating studies across multiple platforms, including viral and non-viral delivery of DNA, CAR-T and NK-cell therapies based upon autologous and allogeneic, or off-the-shelf, strategies. These studies will help inform potential registration pathways and validate technologies that will enable us to achieve our game-changing goals, including delivering therapies for urgent unmet needs, such as progressive brain cancer, and developing personalized TCR-based cell therapies for solid tumors."

"To accelerate the success of our exciting clinical programs, we are building out our clinical and regulatory infrastructure by hiring additional personnel in these important areas of our company," said Caesar J. Belbel, Executive Vice President, Chief Operating Officer and Chief Legal Officer of ZIOPHARM. "Through the highly efficient management of our cash, the addition of these resources in support of our aggressive clinical strategy has had a minimal impact on the projection of our financial resources, which we anticipate will be sufficient to fund our currently planned operations into the fourth quarter of 2017."

Program Updates

Ad-RTS-IL-12 + veledimex

Ad-RTS-hIL-12 + veledimex is a gene therapy candidate for the controlled expression of interleukin 12 (IL-12), a critical protein for stimulating an anti-cancer T-cell immune response, using the RheoSwitch Therapeutic System (RTS) gene switch. ZIOPHARM is currently enrolling patients in two studies of Ad-RTS-hIL-12 + veledimex: a Phase 1b/2 study for the treatment of patients with locally advanced or metastatic breast cancer following standard chemotherapy and a multi-center Phase 1 study in patients with recurrent or progressive glioblastoma multiforme (GBM), an aggressive form of brain cancer.

Encouraging data from Phase 1 brain tumor study reported at SNO; first patient treated in second dose cohort. In November 2015, the Company reported biologic data from the multicenter, Phase 1 gene therapy study of GBM at the Society for Neuro-Oncology (SNO) 20th Annual Scientific Meeting. Following reporting of encouraging data from the first cohort of the study at the initial dosing of Ad-RTS-IL-12 + veledimex, the Company announced this week that the first patient has been enrolled in the study’s second dose cohort. The Company plans to report updated results from the study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016.

Encouraging data from Phase 1b/2 breast cancer study reported. In December 2015, the Company reported encouraging data, including achievement of the 12 week progression free survival endpoint by the first patient, from a Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. The study is being conducted at the Memorial Sloan Kettering Cancer Center in New York. A trial in progress poster describing the study was presented at the San Antonio Breast Cancer Symposium in December 2015. The Company expects to present updated data from the study in 2016.

Preclinical studies combining Ad-RTS-IL-12 + veledimex and checkpoint inhibitors in brain tumor models. ZIOPHARM anticipates presenting data from preclinical studies of Ad-RTS-IL-12 + veledimex combined with checkpoint inhibitors in glioblastoma mouse models at the 2016 Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Washington D.C., May 4-7, 2016.

Adoptive Cell Therapies

ZIOPHARM is developing various immuno-oncology programs, including chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR) and natural killer (NK) adoptive cell-based therapies. These programs are being advanced in collaboration with Intrexon and the MD Anderson Cancer Center and the biopharmaceutical business of Merck KGaA, Darmstadt, Germany (CAR-T only).

Favorable overall survival (OS) and progression free survival (PFS) data from non-viral CAR-modified T cells targeting CD19 presented at ASH (Free ASH Whitepaper). In December 2015, ZIOPHARM announced results from its non-viral CD19-specific CAR T-cell therapy programs were presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Two investigational therapies infused T cells genetically modified to express a CD19-specific CAR into patients with advanced CD19+ malignancies after hematopoietic stem-cell transplantation (HSCT). This was based on non-viral gene transfer using the Sleeping Beauty platform to express the CAR. Long-term follow up data were used to distinguish the benefit of the CAR-T therapies over HSCT. The results demonstrated favorable PFS and OS trends compared to historical controls, with a near doubling of 3-year PFS rates for patients with Diffuse Large B-cell Lymphoma enrolled in the autologous cohort, and a doubling to tripling of 1-year OS rates results for patients with Acute Lymphoblastic Leukemia enrolled in the allogeneic cohort. The non-viral Sleeping Beauty-modified T cells also demonstrated in vivo survival that compared favorably to published results of virally-modified cells.

First patient enrolled in Phase 1 study of second generation non-viral CD19-specific CAR T-cell therapy for advanced lymphoid malignancies. In February 2016, ZIOPHARM announced that the first patient was enrolled in a new Phase 1 clinical study of its second generation non-viral CD19-specific CAR modified T-cell therapy in patients with advance lymphoid malignancies. The CD19-specific T cells were modified using the Sleeping Beauty system to stably express the CAR in T cells. This second-generation study employs a revised CAR construct designed to improve persistence and anti-tumor response over the first generation therapy. Additionally, this investigational treatment is independent of HSCT. The trial, which is being conducted at MD Anderson, will provide further proof-of-concept for the Sleeping Beauty system in a disease setting well studied using virally modified CD19-specific T cells, allowing the system to be applied to areas where viral therapy is more challenging to implement, such as the targeting of neoantigens in solid tumors.

Sleeping Beauty non-viral gene transfer technology featured in Nature Medicine. In January 2016, the Sleeping Beauty non-viral gene transfer technology was featured in a perspectives article in the journal Nature Medicine (Volume 22, Number 1, 26-36), titled "Prospects for gene-engineered T cell immunotherapy for solid cancers." The article describes how adoptive transfer of TCR-engineered T cells for solid tumors may come from the "arduous task of targeting the unique set of mutations that cause each patient’s cancer." Because of the challenges of achieving this goal, the authors note that non-viral integration systems will likely be considerably cheaper to manufacture and easier to implement for single-use applications compared with viral vectors and that, among non-viral platforms, Sleeping Beauty has advanced furthest in clinical development.

The Sleeping Beauty transposon-transposase is a unique non-viral system for introducing genes encoding CARs and TCRs into lymphocytes and is exclusively licensed by Intrexon through MD Anderson and accessed as part of ZIOPHARM’s collaboration with Intrexon. This non-viral approach has several potential advantages over viral delivery systems, including a lower cost of generating genetically modified T cells as well as the ability to generate T cells with minimal ex vivo processing and can serve as a conduit to targeting solid tumor neoantigens using TCRs.

Upcoming Studies

As previously announced, ZIOPHARM anticipates launching clinical studies in three new programs in 2016:

A Phase 1 clinical trial in patients with glioblastoma using the combination of Ad-RTS-IL-12 + veledimex and a selected checkpoint inhibitor.

A Phase 1 study of a viral-based CAR T-cell therapy for myeloid malignancies. Details of the study and antigen target will be provided as the Company initiates the study.

A Phase 1 clinical trial using off-the-shelf primary NK cells for investigational therapy of acute myeloid leukemia, building on promising proof-of-principle trials such as ongoing at MDACC infusing autologous and allogeneic NK cells.

Fourth-Quarter 2015 Financial Results

Net loss for the fourth quarter of 2015 was $9.5 million, or $(0.07) per share, compared to a net loss of $10.4 million, or $(0.09) per share, for the fourth quarter of 2014.

Research and development expenses were $8.1 million for the fourth quarter of 2015 which is consistent with $8.1 million for the fourth quarter of 2014. In 2015, research and development costs include $4.5 million related to CAR-T programs, $1.6 million related to gene therapy programs, $1.3 million in employee related expenses and $0.7 million in other R&D activities.

General and administrative expenses were $3.3 million for the fourth quarter of 2015 compared to $2.9 million for the fourth quarter of 2014. The increase of $0.4 million in general and administrative expenses is primarily attributable to non-cash equity compensation and other employee related expenses.

The Company ended the quarter with cash and cash equivalents of approximately $140.7 million. Given current development plans, the Company anticipates that current cash resources will be sufficient to fund our planned operations into the fourth quarter of 2017.

Kite Pharma Augments Commercial Leadership Team

On February 24, 2016 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT) products for the treatment of cancer, reported the formation of the company’s integrated commercial leadership team with the appointment of three senior-level industry executives (Press release, Kite Pharma, FEB 24, 2016, View Source [SID:1234509179]). The team will be responsible for all aspects of commercial and medical affairs strategy, planning, and analysis for the potential launch of KTE-C19, an investigational engineered T cell therapy for patients with relapsed and/or refractory B cell malignancies.

The new commercial and medical affairs leadership team includes Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research; Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs; and Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development. The group will report to Shawn Tomasello, Kite’s Chief Commercial Officer. Dr. Faust will also report to Jeff Wiezorek, M.D., M.S., Senior Vice President of Clinical Development.

"Commercial readiness is a top priority for Kite as we prepare for pivotal data from the ZUMA-1 study and potential U.S. regulatory filing for KTE-C19 this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Such a potentially transformative therapy as KTE-C19 will require a creative and strategic commercialization model to optimize access and impact for patients. We believe this proven and accomplished team, under the direction of Shawn Tomasello, can deliver on this promise."

"It is a privilege to welcome Diane, Elizabeth, and Kimberly to Kite," said Shawn Tomasello, Chief Commercial Officer. "As a group, they bring the range of critical skills and proven capabilities needed to prepare for commercialization. They have been closely involved in the launch of several major oncology therapies, and they understand how markets are reshaped by therapeutic innovations that improve patient outcomes. Our team is already fully engaged in market analysis and strategy development activities."

Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research

Ms. Parks joins Kite from Pharmacyclics, where she was Vice President of Marketing. During her tenure at Pharmacyclics, Ms. Parks led the development and execution of all global marketing strategies for IMBRUVICA. Previously, she held senior leadership roles as Vice President of Sales for Amgen, representing oncology and nephrology products, and Senior Vice President of Specialty Biotherapeutics and Managed Care at Genentech, where she led the launches of multiple products as well as commercial development of LUCENTIS and RITUXAN. Ms. Parks began her career at Marion Merrell Dow. She holds a BS from Kansas State University and an MBA from Georgia State University.

Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs

Prior to joining Kite, Dr. Faust was Vice President of Medical Affairs at Pharmacyclics, during which time she planned and successfully executed four IMBRUVICA launches for various indications. Before Pharmacyclics, Dr. Faust was Vice President of Clinical Sciences Research at Celgene Corporation, serving as the national lead for oncology Regional Medical Liaisons in the US, and as Senior Director of Medical Affairs at Gloucester Pharmaceuticals, which was acquired by Celgene in 2010. From 1995 to 2007, Dr. Faust held roles of increasing responsibility in research, development, and medical affairs at Amgen, including Executive Director, Oncology Regional Medical Liaisons. Dr. Faust has co-authored numerous publications and was the former President-Elect for the Pacific Southwest Chapter of the American Medical Writers Association. She holds a BS in microbiology from Auburn University, a MA in biology from University of California Riverside, and a PhD in microbiology and molecular genetics from University of California Los Angeles.

Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development

Ms. Metcalf most recently served as Vice President of Commercial Training and Administration at Pharmacyclics, where she was responsible for developing and executing commercial and medical affairs training including launch plans for IMBRUVICA. Previously, she spent eight years at Celgene Corporation where she contributed significantly to building the commercial training department and assumed roles of increasing responsibility in commercial training, market access, and sales and marketing operations, including Executive Director, US National and Regional Accounts. During her tenure at Celgene, she launched POMALYST, ISTODAX and OTEZLA. Ms. Metcalf began her career in biopharma at Pfizer. She holds a BS from Northwestern University, an MBA from West Chester University, and a Master of Health Systems from The University of Medicine & Dentistry of New Jersey.

About KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B cell malignancies. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications.

bluebird bio Reports Fourth Quarter and Full Year 2015 Financial Results and Recent Operational Progress

On February 24, 2016 bluebird bio, Inc. (Nasdaq: BLUE) a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2015 (Press release, bluebird bio, FEB 24, 2016, View Source;p=RssLanding&cat=news&id=2142878 [SID:1234509175]).

"In 2015 bluebird bio defined an accelerated regulatory path for LentiGlobin in ß-thalassemia and established a powerful reason to believe in LentiGlobin in sickle cell disease, though there is still more to learn as we treat additional patients. We also fully enrolled our Starbeam study of Lenti-D in cerebral adrenoleukodystrophy and made significant advances in building a competitive T cell oncology franchise," said Nick Leschly, chief bluebird. "In 2016 we are excited to learn even more across all of our programs and continue to innovate and improve. We are particularly looking forward to sharing data from the Starbeam study for the first time and presenting more data with longer follow-up from all three of our LentiGlobin clinical studies."

Recent Highlights

ADVANCED FIRST ONCOLOGY PROGRAM INTO THE CLINIC – Earlier in February, the first patient was infused in the CRB-401 study of bb2121 in relapsed/refractory multiple myeloma. Additionally, Celgene has exercised its option to exclusively license bb2121, under the terms of the collaboration agreement between the two companies. bluebird bio will receive a $10.0 million option exercise payment from Celgene and is also eligible to receive specified development and regulatory milestone payments and royalty payments on net sales.

PRESENTED UPDATED CLINICAL DATA IN ß-THALASSEMIA FROM HGB-204 AND HGB-205 CLINICAL STUDIES OF LENTIGLOBIN AT ASH (Free ASH Whitepaper) – In December 2015, investigators presented data from bluebird bio’s ongoing clinical studies in transfusion-dependent ß-thalassemia (TDT) and severe sickle cell disease (SCD). Data in patients with TDT from the HGB-204 and HGB-205 studies showed that 100% of patients with non-ß0/ß0 genotypes achieved sustained transfusion independence as of the data cut-off, ranging from 7.1 months to 23.4 months. Patients with the ß0/ß0 genotype all saw reductions in their transfusion needs, ranging from a 33% to 100% reduction.

PRESENTED CLINICAL DATA IN SICKLE CELL DISEASE FROM HGB-205 AND HGB-206 CLINICAL STUDIES OF LENTIGLOBIN AT ASH (Free ASH Whitepaper) –Marina Cavazzana, M.D., Ph.D., of Hospital Necker, University Paris Descartes, presented updated data on one patient with SCD from the HGB-205 study, who remained free of transfusions, hospitalizations and acute SCD-related events for more than nine months as of the data cut-off. At the 12-month post-drug infusion follow-up, the proportion of anti-sickling hemoglobin in this patient accounted for 49% (47% HbAT87Q + 2% HbF) of all hemoglobin production – well above the 30% threshold anticipated to achieve a disease-modifying effect. John Tisdale, M.D., of the National Institutes of Health presented early data from the HGB-206 study, in which two patients had at least three months of post-infusion follow-up. At the three-month post-infusion follow-up for Subject 1301, anti-sickling hemoglobin accounted for 17% of all hemoglobin production (4% HbAT87Q + 13% HbF). At the six-month post-infusion follow-up for subject 1303, anti-sickling hemoglobin accounted for 16 percent of all hemoglobin production (12% HbAT87Q + 4% HbF).

PRESENTED PRE-CLINICAL AND MANUFACTURING DATA FROM CAR T ONCOLOGY PROGRAMS AT ASH (Free ASH Whitepaper) – bluebird bio scientists presented three posters at ASH (Free ASH Whitepaper), covering critical basic research, translational and manufacturing aspects of the Company’s T cell oncology programs. One poster discussed an important observation made by bluebird bio scientists: culturing anti-BCMA CAR T cells with a PI3K inhibitor generated a product with many of the properties of younger, less differentiated T cells. Consistent with a younger T cell phenotype, this product showed improved in vivo efficacy and persistence in multiple model systems.
SHARED DATA ON PLATFORM IMPROVEMENTS – In an investor event at ASH (Free ASH Whitepaper), bluebird bio chief scientific officer Philip Gregory, D.Phil., presented data from ongoing research to improve the cell transduction process for LentiGlobin. The presentation showed that in preclinical experiments, adding selected compounds to the transduction process resulted in substantially increased vector copy number and transduction efficiency (i.e. percentage of corrected cells). Importantly, the new process was shown to be robust with similar improvements seen across multiple donors and vector lots.

ENTERED INTO CAR T LICENSE WITH VIROMED – Signed exclusive license agreement with Viromed Co., Ltd., to research, develop and commercialize CAR T therapies using Viromed’s proprietary humanized antibody to an undisclosed cancer target in solid tumors.

Upcoming Anticipated Milestones

Presentation of interim data from the Starbeam study of Lenti-D in patients with cerebral adrenoleukodystrophy (CALD) at the American Academy of Neurology annual meeting in April 2016

Update on LentiGlobin process improvements in the second half of 2016

Initiation of the HGB-207 study in patients with TDT with the non-ß0/ß0 genotype in the second half of 2016

Presentation of updated data from the HGB-204, HGB-205 and HGB-206 studies at the ASH (Free ASH Whitepaper) annual meeting in December 2016
Fourth Quarter and Full Year 2015 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2015 were $865.8 million, compared to $492.0 million as of December 31, 2014, an increase of $373.8 million, which was primarily driven by the June 2015 equity financing partially offset by cash used to fund operations.

Revenues: Collaboration revenue was $1.5 million for the fourth quarter of 2015 and $14.1 million for the year ended December 31, 2015, compared to $6.3 million and $25.0 million in the comparable periods in 2014. The decrease is a result of an amendment to our collaboration agreement with Celgene in the second quarter of 2015.

R&D Expenses: Research and development expenses were $35.7 million for the fourth quarter of 2015 and $134.0 million for the year ended December 31, 2015, compared to $20.5 million and $62.6 million for the comparable periods in 2014. The increase in research and development expenses was primarily attributable to increased employee compensation expense due to increased headcount, in-licensing milestones and fees, and manufacturing and clinical trial-related costs to support our advancing pipeline.

G&A Expenses: General and administrative expenses were $14.4 million for the fourth quarter of 2015 and $46.2 million for the year ended December 31, 2015, compared to $5.3 million and $23.2 million for the comparable periods in 2014. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to increased headcount, and consulting and facilities-related costs to support our overall growth.

Net Loss: Net loss was $47.3 million for the fourth quarter of 2015 and $166.8 million for the year ended December 31, 2015, compared to net loss of $19.5 million and $48.7 million for the comparable periods in 2014.

Financial guidance: bluebird bio expects that its cash, cash equivalents and marketable securities of $865.8 million as of December 31, 2015 will be sufficient to fund its current operations through 2018.

NIH uses photon-counting CT scanner in patients for the first time

On February 24, 2016 The Clinical Center at the National Institutes of Health reported that they are investigating the potential use of a new generation of a computerized tomography (CT) scanner, called a photon-counting detector CT scanner, in a clinical setting (Press release, NIH, FEB 24, 2016, View Source [SID:1234509173]). The prototype technology is expected to replicate the image quality of conventional CT scanning, but may also provide health care specialists with an enhanced look inside the body through multi-energy imaging. Patients could receive a minimum amount of radiation, while the maximal amount of information needed would be delivered to health care providers.

Over the next five years, David Bluemke, M.D., Ph.D., chief of the Department of Radiology and Imaging Sciences, and his team will continue to develop scan protocols and image processing algorithms, which could improve screening, imaging, and treatment planning for health conditions like cancer and cardiovascular disease.

"The NIH Clinical Center has helped shape and share research advances and health care for decades. Now is an exciting time for us and for our study participants here in the Clinical Center as we help test and develop this CT technology so that it may one day help patients around the world and impact the health care they receive," said Dr. Bluemke.

As the world’s largest hospital solely dedicated to research, the NIH Clinical Center sees thousands of patients every year, many of whom have rare and complicated illnesses. In the treatment and study of disease, surgery is often viewed as the last option. CT scanning is one way that doctors can examine the body’s internal features in a non-surgical way. In collaboration and through a partnership known as a cooperative research and development agreement with the manufacturer, Siemens Healthcare, and researchers in the CT technology field, the Clinical Center is testing this technology to help the health care field optimize the scanner for clinical use across the U.S. and around the globe.

Image of photon-counting CT scan
Photon CT scan image of a research subject at the NIH. Greater amounts of iodine contrast are shown in brighter, yellow colors.
The Clinical Center is one of three sites in the world to use this technology and is the first hospital-based research setting of the device. More than 45 volunteers enrolled in a research protocol have benefited from this cutting edge equipment. Initial findings have been reported in Radiology (link is external).

By advancing this technology, researchers aim to improve the diagnosis that doctors can offer by increasing the resolution and contrasts available for analysis. Areas of research investigation with the new technology include:

Doctors can identify materials in the body with anatomic precision. A dye, or contrast, is often given to a patient so that researchers can see a selected area in more detail. Different materials in the body can be displayed in different colors for faster diagnosis and precision.
The new technology may be used to help identify and characterize tumors, plaques or vessels that are smaller than half a millimeter. For many patients, finding a tumor that size may make a difference in identifying if it is benign or could be cancerous.
The technology may help to more accurately identify soft tissues such as proteins, tendons or collagen which are hard to differentiate with current equipment.

Bayer proposes increased dividend for 2015 of EUR 2.50 per share

On February 24, 2016, At its meeting today, the Supervisory Board of Bayer AG announced that they have approved the Board of Management’s recommendation that a dividend payment of EUR 2.50 (2014: EUR 2.25) per share be proposed to the Annual Stockholders’ Meeting on April 29, 2016 (Press release, Bayer, FEB 24, 2016, View Source [SID:1234509168]). "2015 was a very good year for Bayer. We would like our stockholders to share appropriately in this success," explained Bayer CEO Dr. Marijn Dekkers. With 826,947,808 shares entitled to the dividend, the total dividend payment would amount to EUR 2,067 million (2014: EUR 1,861 million), an increase of 11.1 percent.

The Bayer Group’s consolidated financial statements for 2015 will be presented and discussed at the Financial News Conference on February 25, 2016.