Elbit Imaging Stock

Elbit Imaging Ltd., together with its subsidiaries, operates in the field of development, production, and marketing of treatment-oriented medical systems.

Medical Companies

The company’s medical portfolio is held by Elbit Medical Technologies Ltd. (Elbit Medical). Elbit Medical holds shares in two medical companies, such as InSightec Ltd. (InSightec) and Gamida Cell Ltd. (Gamida).

InSightec

InSightec operates in the field of development, production, and marketing of treatment-oriented medical systems, based on a technological platform combining the use of focused ultrasound and magnetic resonance imaging for the purpose of performing noninvasive treatments in human beings.

InSightec develops and markets Exablate, the U.S. Federal and Drug Administrative (FDA) approved magnetic resonance imaging guided focused ultrasound treatment platform (MRgFUS) for various neurosurgery, oncology and gynecology indications. Treatments are non-invasive and are performed in an ambulatory setting.

InSightec’s MRgFUS technology integrates the therapeutic effects of focused ultrasound energy with the precision guidance and treatment outcome monitoring provided by magnetic resonance imaging (MRI) systems. Ultrasound is a form of energy that could pass through skin, muscle, fat and other soft tissue; and is used in diagnostic applications. The ExAblate uses a phased-array transducer that generates a high intensity, focused beam of ultrasound energy, or a sonication, aimed at a small volume of targeted tissue.

Clinical and Regulatory Development in InSightec’s Products

ExAblate Neuro (Brain System or Neuro System)

The brain system is based on the MRgFUS technology, which relies on MRI imaging to plan, guide execution, and receive real-time response during treatment, adopted for use on the brain. The patient interface in this system consists of a helmet-like acoustic projection system with the patient’s head held within the helmet. The projector allows electronic shaping of the acoustic beam, as required for intracranial treatment. The brain system has been given approval for commercial use in the U.S.A., Europe, Japan, Korea, Canada, Taiwan, and Israel for the treatment of functioning disorders (essential tremors, and/or tremors resulting from Parkinson’s disease, and/or neuropathic pain). The system is also undergoing clinical evaluation for the treatment of advanced Parkinson’s disease, epilepsy, OCD, depression, and neuropathic pain, as well as drug-based and treatment by means of temporary and transient opening of the blood-brain barrier for the treatment of brain tumors and Alzheimer’s Disease. The system is compatible with various MRI systems from both GE (GE Healthcare, a division of the General Electric Company) and Siemens Healthcare GmbH (Siemens).

ExAblate for Body Platform (the ‘Body System’)

The body system, like the brain system, based on the MRgFUS technology, which relies on MRI imaging for treatment planning and guidance, and for real-time feedback. As of December 30, 2018, the body system was adapted for use with MRI machines made by GE. The body system constitutes a multi-application treatment platform. The system is being sold to customers interested in treating various body applications, requiring the use of any of body transducers (a component converting a physical signal into an electric one). The system has been planned for the treatment of fibroids, organ-confined, prostate cancer, bone tumors and in various configurations, and in the future for liver, pancreas and renal tumors. Some of the indications have received regulatory approval in various parts of the world, and some are still in the research and development stage.

Distribution and Marketing

InSightec has two main distributing channels, such as the first one is InSightec’s independent business department and the second one is by distributors and local agencies among them is GE healthcare representatives (without exclusivity) and other distribution agreements with third parties.

Business Strategy

Insightec’s strategy focuses on the development of two product lines, a product line in the field of body systems (oncology and gynecology) and a line of products in the field of brain treatment systems (neurological disorders and tumors).

In the field of brain systems, Insightec intends to develop applications that would make use of advanced mechanisms of interactions between tissues and acoustic fields (for example, targeted drug delivery), neuromodulation, and more.

Gamida

Gamida operates in the field of research, development and manufacture of products designated for certain cancer diseases.

Gamida is a clinical-stage biopharmaceutical company committed to developing advanced cell therapies with the potential to cure cancer and rare, serious hematologic diseases. Gamida have leveraged the company’s nicotinamide-based, or NAM-based, cell expansion technology to develop a pipeline of products designed to address the limitations of cell therapies. Gamida’s proprietary technology is designed to allow for the proliferation of donor cells while maintaining the cells’ functional therapeutic characteristics, which if approved, would provide a treatment alternative for patients.

Gamida’s advanced product candidate, NiCord, is an investigational advanced cell therapy based on NAM-expanded cord blood designed to improve and expand the life-saving benefits of hematopoietic stem cell (bone marrow) transplant. Gamida is enrolling patients in a pivotal Phase 3 clinical trial in approximately 120 patients with various hematologic malignancies, including high risk leukemias such as acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, and lymphomas. Gamida anticipates reporting top-line data from this trial in the first half of 2020.

In Gamida’s Phase 1/2 clinical trials, patients who were transplanted with NiCord achieved rapid engraftment and immune reconstitution, which are key indicators of clinical benefits. Data from the Phase 1/2 clinical study were published in the Journal of Clinical Oncology in December 2018. Based on the results of Gamida’s Phase 1/2 clinical trials, Gamida received Breakthrough Therapy Designation for NiCord in the United States from the FDA. Furthermore, Gamida received orphan drug designation from both the FDA and the European Medicines Agency.

Gamida is also developing NiCord for the treatment of other rare, life-threatening hematologic diseases, including severe aplastic anemia, a bone marrow failure disease, which is being investigated in a Phase 1/2 trial sponsored by the National Institutes of Health. In addition, Gamida applied its NAM-based cell expansion technology to natural killer (NK) cells to develop Gamida’s product candidate, NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors, being evaluated in a Phase 1 investigator-sponsored trial for the treatment of relapsed or refractory non-Hodgkin lymphoma and multiple myeloma.

In addition, in February 2019, Gamida and Editas Medicine entered into a collaboration agreement to evaluate the use of Editas Medicine’s CRISPR technology to edit NAM-NK cells. The two companies would engage in joint research to evaluate unnamed targets by combining Gamida’s proprietary NAM-based cell expansion technology with Editas Medicine’s CRISPR technology. The research initiative focuses on exploring the potential to edit NAM-NK cells to further optimize their tumor-killing properties.

Gamida’s Strategy

The key strategies of Gamida are to complete Phase 3 clinical development and obtain regulatory approval for NiCord in hematologic malignancies; advance NiCord for the treatment of severe aplastic anemia in an ongoing Phase 1/2 clinical trial; investigate the potential of NAM-NK in conjunction with therapeutic antibodies in additional cancer indications; improve commercial value of the company’s product candidates; centralize manufacturing capabilities to deliver a pharmaceutical grade product to meet commercial demand; demonstrate NiCord’s value through Health Economics Outcomes Research; and expand its pipeline of cell therapy product candidates by leveraging its cell expansion technology.

Plots in India

The company’s plots in India are owned by the company’s subsidiary, Elbit Plaza India Real Estate Holdings Limited (EPI). EPI is held 47.5% directly by the company. EPI holds two plots in India (in Bangalore and Chennai).

Business Concept and Strategy

The company’s business concept and strategy in the respect of its Bangalore, India project and the Chennai, India project is to transfer its proprietary interests in the plots to third parties.

Patents and Proprietary Rights, and Licenses

InSightec’s intellectual property includes ownership approximately 171 patents. In addition, InSightec has submitted approximately 70 patent applications, which remain pending and in process. InSightec has registered trademarks for ‘ExAblate’ and ‘InSightec’ in the United States, European Union, Canada, and Israel, as well as ‘INSIGHTEC BRINGING THERAPY INTO FOCUS & DESIGN’ (Old company logo) in the United States.

As of December 31, 2018, Gamida owned 40 issued patents and 15 pending patent applications worldwide, including 12 U.S. issued patents, two pending U.S. non-provisional patent applications, one pending U.S. provisional patent application and three pending PCT applications. Gamida owns two issued patents in the United States and 16 issued foreign patents related to Gamida’s NiCord product candidate. The patents that Gamida owns outside of the United States are granted in Australia, Canada, Europe, Hong Kong, Israel, Japan, Singapore, and South Africa.

In addition, Gamida owns one pending U.S. non-provisional patent application, one pending U.S. provisional patent application and two pending PCT applications related to the company’s NiCord product candidate. These patents and pending patent applications contain composition-of-matter claims to Gamida’s NiCord product candidate and claims to methods of producing and methods of treatment using Gamida’s NiCord product candidate.

Gamida owns six issued foreign patents related to Gamida’s NAM-NK product candidate. The patents that Gamida owns outside of the United States are granted in Australia, Europe, Hong Kong, Israel, and Japan. In addition, Gamida owns one pending U.S. non-provisional patent application, one pending PCT application and six pending foreign patent applications related to the company’s NAM-NK product candidate. These patents and pending patent applications contain composition-of-matter claims to Gamida’s NAM-NK product candidate and claims to methods of producing and methods of treatment using Gamida’s NAM-NK product candidate. In addition, Gamida filed for and obtained trademark registration in the United States, China, Europe, Hong Kong and Israel for ‘NiCord’.

Governmental Regulation

The testing, manufacture and sale of InSightec’s products are subject to regulation by various governmental authorities, principally the FDA, the EEC, and corresponding state and foreign regulatory agencies.

Competition

GE’s main competitors in magnetic resonance imaging are Philips and Siemens.

History

Elbit Imaging Ltd. was founded in 1996. The company was incorporated in 1996 under the laws of the state of Israel.