Quarterly report pursuant to Section 13 or 15(d)

Nature of Operations and Basis of Presentation

v3.7.0.1
Nature of Operations and Basis of Presentation
9 Months Ended
Apr. 30, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Operations and Basis of Presentation

Note 1—Nature of Operations and Basis of Presentation

 

OncoSec Medical Incorporated (the “Company”) began its operations as a biotechnology company in March 2011, following its completion of the acquisition of certain technology and related assets from Inovio Pharmaceuticals, Inc. (“Inovio”) pursuant to an asset purchase agreement dated March 14, 2011. The Company has not produced any revenues, nor has it commenced planned principal operations. The Company’s technology includes certain delivery technologies including ImmunoPulse®, an electroporation delivery device that is used in combination with the Company’s therapeutic product candidates, including DNA plasmids that encode immunologically active agents, to deliver the therapeutic directly into the tumor and promote an inflammatory response against the cancer. The Company was incorporated in the State of Nevada on February 8, 2008 under the name of Netventory Solutions, Inc. and changed its name in March 2011 when it began operating as a biotechnology company.

 

The Company’s core technology, the ImmunoPulse® platform, is a unique therapeutic modality intended to reverse the immunosuppressive microenvironment in the tumor and engender a systemic anti-tumor response against untreated tumors in other parts of the body. The Company’s lead product candidate, ImmunoPulse® IL-12, consists of a proprietary electroporation delivery device (an electrical pulse generator and disposable applicators) and DNA-encoded interleukin-12 (“IL-12”). ImmunoPulse® IL-12 is clinically and preclinically validated to drive tumor infiltrating lymphocytes and stimulate anti-cancer immune activity. The Company believes the therapy may be used to treat multiple tumor types and can be used in combination with other therapies.

 

During the quarter ended April 30, 2017, the investigator continued to enroll patients in an investigator-sponsored combination trial of ImmunoPulse® IL-12 with pembrolizumab in patients with advanced, metastatic melanoma. The Company also amended the clinical protocol for its biomarker-focused pilot study of ImmunoPulse® IL-12 in triple negative breast cancer, in order to improve the enrollment rate for that study. The Company’s Phase II clinical trials of ImmunoPulse® IL-12 as a monotherapy in Merkel Cell carcinoma, melanoma, and head and neck squamous cell carcinoma are now closed for enrollment and database-locked; clinical study reports are being drafted. The Company’s Phase II clinical trial of ImmunoPulse® IL-12 as a monotherapy in Cutaneous T-cell lymphoma is closed.

 

In addition, the Company made further advancements toward prototypes of its next generation electroporation devices and pursued discovery research to identify new gene combinations for use with the ImmunoPulse® platform. The Company’s efforts are focused on moving ImmunoPulse® IL-12 toward a potential registration pathway for metastatic melanoma and to pursue clinically relevant data in breast cancer and additional combination trials.

 

On October 7, 2016, OncoSec Medical Australia Pty, Ltd. (“OncoSec Australia”) was created as a wholly-owned subsidiary of OncoSec Medical Incorporated to facilitate the potential operation of clinical trials principally in Australia where there is a high rate of melanoma cases. OncoSec Australia issued 100 shares (AU$1.00 par value) to the Company for AU$100. OncoSec Australia’s functional currency, the Australian dollar, is also its reporting currency. Its financial statements are translated to US dollars, the reporting currency of the Company, prior to consolidation. All intercompany accounts and transactions have been eliminated in consolidation.

  

Unaudited Interim Financial Information

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of April 30, 2017, condensed consolidated statements of operations and condensed statements of operations, condensed consolidated statements of comprehensive loss and condensed statements of comprehensive loss for the three and nine months ended April 30, 2017 and 2016, respectively, and the condensed consolidated statement of cash flows and the condensed statement of cash flows for the nine months ended April 30, 2017 and 2016, respectively, are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented. The condensed consolidated results of operations and condensed results of operations for the three and nine months ended April 30, 2017 shown herein are not necessarily indicative of the consolidated results that may be expected for the year ending July 31, 2017, or for any other period. These financial statements, and notes thereto, should be read in conjunction with the audited financial statements for the year ended July 31, 2016, included in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on October 13, 2016. The balance sheet at July 31, 2016 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements.

 

Reclassifications

 

Certain amounts in the condensed balance sheet for the year ended July 31, 2016 and the condensed consolidated statement of cash flows for the nine-month period ended April 30, 2017 have been reclassified to conform to the interim presentation of prepaid expenses, other current assets and property and equipment.