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7 7  OncoSec Medical is a biotechnology company focused on designing, developing and commercializing innovative therapies and proprietary medical approaches to stimulate and guide an anti-tumor immune response for the treatment of cancer. The company's core platform technology, ImmunoPulse®, is a drug-device therapeutic modality comprised of a proprietary intratumoral electroporation delivery device. The ImmunoPulse® platform is designed to deliver DNA-encoded drugs directly into a solid tumor and promote an inflammatory response against cancer. The ImmunoPulse® device can be adapted to treat different tumor types, and consists of an electrical pulse generator, a reusable handle and disposable applicators. The company's lead product candidate, ImmunoPulse® IL-12, uses its electroporation device to deliver a DNA-encoded interleukin-12, or IL-12, called tavokinogene telseplasmid, or tavo, with the aim of reversing the immunosuppressive microenvironment in the tumor and engendering a systemic anti-tumor response against untreated tumors in other parts of the body.
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80 80  
81 81  The company's lead product candidate, ImmunoPulse® IL-12, consists of a plasmid construct encoding the proinflammatory cytokine IL-12 that is delivered into the tumor through in vivo electroporation using its ImmunoPulse® technology. OncoSec Medical is also researching other DNA-encoded, immunologically-active molecules, with an aim of developing additional immunotherapeutic drugs that, when delivered through electroporation using its ImmunoPulse® platform, may be capable of breaking the immune system’s tolerance to cancer.
82 82  
83 -==== Commercialization ====
83 += Commercialization =
84 84  
85 -**Strategy**
85 +== Strategy ==
86 86  
87 87  The company's primary focus is to continue its clinical development strategy for ImmunoPulse® IL-12, including its currently planned and ongoing Phase II clinical trials discussed under “Clinical Programs” above and potentially other Phase II or subsequent trials the company may pursue in the future, which may include trials focused on cancers that have demonstrated a response to anti-PD-1/PD-L1 checkpoint therapies, such as metastatic melanoma.
88 88  
89 89  As a part of its commercialization strategy, the company also regularly investigate and evaluate potential collaboration opportunities, to identify rational combinations with existing and emerging monoclonal antibody therapies and other drugs. For instance, the company may seek to collaborate with pharmaceutical or biotechnology companies or government agencies to provide it with access to complementary technologies and/or greater resources. In addition, the company may seek to expand the applications of its technologies through strategic collaborations or other opportunities, such as in-licensing or strategic acquisitions, and the company may seek to out-license its intellectual property to other companies to leverage its technologies for applications that the company may not choose to internally and independently development.
90 90  
91 -**Manufacturing and Supply**
91 +== Manufacturing and Supply ==
92 92  
93 93  Currently, the company assemble certain components of its electroporation system, which is its proprietary delivery mechanism for its ImmunoPulse IL-12® product candidate, and the company utilize the services of contract manufacturers to manufacture the remaining components of these systems and for the manufacture, testing and storage of all of its supply of its plasmid product candidate for clinical trials or other studies. The manufacture of its systems and product supplies requires significant expertise and capital investment, including the use of advanced manufacturing techniques and process controls, and the company do not own and have no plans to build its own clinical or commercial manufacturing capabilities. The company expect to increase its reliance on third-party manufacturers if and when the company commercialize any of its product candidates and systems.
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96 96  
97 97  OncoSec Medical is certified by all appropriate standards and authorities for the limited assembly and manufacture activities the company conduct, and the company and have established an audited quality management system for these activities. In addition, all contract manufacturers that the company use must comply with various requirements enforced by the FDA through its facilities inspection programs. See “Regulation” below for more information.
98 98  
99 -==== Performance Outlook ====
99 += Performance Outlook =
100 100  
101 101  The company expect to use its available working capital in the near term primarily for the advancement of its existing and planned clinical programs, including primarily the initiation of the PISCES/KEYNOTE-695 study and, to a lesser extent, the continuation of its other clinical trials and studies described above. The company anticipate its spending on clinical programs and the development of its next-generation electroporation device for its ImmunoPulse® IL-12 platform will increase throughout its current fiscal year, primarily in support of the PISCES/KEYNOTE-695 study, while its spending on research and development programs will decrease due to its focus on the PISCES/KEYNOTE-695 study. The company expect its cash-based general and administrative expenses to remain relatively flat in the near term, as the company seek to continue to leverage internal resources and automate processes to decrease its outside services expenses. See “Results of Operations” below for more information.
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103 += References =
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