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ONCS > SEC Filings for ONCS > Form 10-Q on 14-Mar-2014All Recent SEC Filings

Show all filings for ONCOSEC MEDICAL INC

Form 10-Q for ONCOSEC MEDICAL INC


14-Mar-2014

Quarterly Report


ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Cautionary Statement

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our Unaudited Consolidated Financial Statements and the related notes thereto contained in Part I, Item 1 of this Report. The information contained in this Quarterly Report on Form 10-Q is not a complete description of our business or the risks associated with an investment in our common stock. We urge you to carefully review and consider the various disclosures made by us in this Report and in our other reports filed with the Securities and Exchange Commission, or SEC, including our Annual Report on Form 10-K for the fiscal year ended July 31, 2013, our subsequent quarterly reports on Form 10-Q and our subsequent reports on Form 8-K, which discuss our business in greater detail.

This quarterly report on Form 10-Q contains forward-looking statements that involve risks, uncertainties and assumptions. If such risks or uncertainties materialize or such assumptions prove incorrect, our results could differ materially from those expressed or implied by such forward-looking statements and assumptions. In some cases, you can identify forward-looking statements by terminology such as "may", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "potential" or "continue" or the negative of these terms or other comparable terminology. All statements made in this Form 10-Q other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled "Risk Factors" in Part II, Item IA of this Quarterly Report on Form 10-Q, and similar discussions in our other SEC filings. Risks that could cause actual results to differ from those contained in the forward-looking statements include but are not limited to risks related to: our ability to continue as a going concern; our need to raise additional capital and our ability to obtain financing; uncertainties inherent in pre-clinical studies and clinical trials and our ability to commercialize our products; our expected reliance on third parties; general economic and business conditions; our limited operating history; our ability to recruit and retain qualified personnel; competition we face within our industry; our ability to manage future growth; our ability to develop our planned products; our ability to protect our intellectual property; and various risks related to our common stock. These forward-looking statements speak only as of the date of this Form 10-Q, except as required by applicable law, we do not intend to update any of these forward-looking statements.

As used in this quarterly report on Form 10-Q and unless otherwise indicated, the terms "the Company", "we", "us" and "our" refer to OncoSec Medical Incorporated.

Company Overview

We were incorporated under the laws of the State of Nevada on February 8, 2008 under the name Netventory Solutions Inc. to pursue the business of inventory management solutions. Effective March 1, 2011, we consummated a 32 for one forward stock split of our common stock and completed a merger with our subsidiary, OncoSec Medical Incorporated, a Nevada corporation which was incorporated solely to change our name to "OncoSec Medical Incorporated".

Asset Purchase Agreement

We have acquired certain assets pursuant to our Asset Purchase Agreement with Inovio Pharmaceuticals, Inc. ("Inovio"), dated March 14, 2011 (as amended, the "Asset Purchase Agreement"). The acquired assets relate to certain non-DNA vaccine technology and intellectual property relating to selective tumor ablation technologies, which we now refer to as the OncoSec Medical System ("OMS"), a therapy which uses an electroporation device to facilitate delivery of chemotherapy agents, or nucleic acids encoding cytokines, into tumors and/or surrounding tissue for the treatment and diagnosis of various cancers. The acquired assets included various assets related to the OMS technology.

We did not assume any liabilities of Inovio except liabilities under the assigned contracts and assigned intellectual property arising after the closing date of the Asset Purchase Agreement. We agreed to pay Inovio $3,000,000 in scheduled payments beginning on the closing date as well as certain royalties in the event we commercialize our OMS technology. We made the final payment to Inovio of $1 million on December 19, 2013. As as result, we are not subject to further scheduled payment obligations to Inovio pursuant to the Asset Purhase Agreement.

We have entered into amendments to the Asset Purchase Agreement with Inovio in September 2011 (the "First Amendment") and in March 2012 (the "Second Amendment") to modify the terms of our payment obligations (among other modifications). In consideration for the First Amendment, we issued to Inovio a warrant to purchase 1,000,000 shares of common stock with an exercise price of $1.20 per share. In consideration for the Second Amendment, we issued to Inovio a warrant to purchase 3,000,000 shares of our common stock with an exercise price of $1.00 per share. Each of the warrants is subject to a five year term. Each of the warrants also contains a mandatory exercise provision allowing us to request the exercise of the warrant in whole provided that our daily market price (as defined in the warrant) is equal to or greater than $2.40 for twenty consecutive trading days. We completed an evaluation of the warrants issued to Inovio and determined the warrants should be classified as equity within our consolidated balance sheet.


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We are also party to a cross-license agreement with Inovio, which we entered into concurrently with the closing of our asset acquisition. This agreement provides for the exclusive license to Inovio of rights related to certain OMS technology patents in the field of gene or nucleic acids, outside of those encoding cytokines, delivered by electroporation and for the non-exclusive cross-license by Inovio to us of rights related to certain non-OMS technology patents in the OMS field in exchange for specified sublicensing and other licensing fees and royalties.

We are focused on designing, developing and commercializing innovative and proprietary medical approaches for the treatment of solid tumors where currently approved therapies are inadequate based on their therapeutic benefit or side-effect profile. Our therapies are based on the use of electroporation to deliver active therapeutic agents to treat solid tumors. Our goal is to improve the lives of people suffering from the life-altering effects of cancer through the development of our novel treatment approaches. In pursuit of our goal, we have initiated three Phase II clinical trials for the use of our therapies to treat metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. We also continue to investigate collaboration opportunities that will enable us to identify combinations with current standards of care, using immune-modulating checkpoint inhibitors (i.e. anti-CTLA-4 or anti-PD-1) that may improve the efficacy of standard of care. Also, we continue to seek additional clinical development opportunities to expand our clinical pipeline. Funding for these potential new programs may come from third parties, non-dilutive grant funding or establishment of strategic partnerships.

Appointment of Chief Medical Officer

Effective December 11, 2013, we appointed Dr. Robert Pierce as our Chief Medical Officer and Vice President, Research and Development. In connection with Dr. Pierce's appointment, effective as of December 11, 2013, we entered into an executive employment agreement (the "Employment Agreement") with Dr. Pierce. The Employment Agreement provides for an initial annual base salary of $260,000, as well as eligibility to receive an annual bonus at the discretion of our Board of Directors. In connection with Dr. Pierce's appointment and pursuant to the terms of his Employment Agreement, effective as of December 11, 2013, we granted to Dr. Pierce a stock option to purchase up to 1,700,000 shares of our common stock. The stock option has an exercise price of $0.31 per share, equal to the closing price of our common stock on the date of grant of the stock option. The stock option has a ten year term and vests pursuant to the following schedule, subject to Dr. Pierce's continued service to us through each vesting date: 34% of the shares subject to the stock option vested upon the date of grant, 33% shall vest on the one-year anniversary of the date of grant, and 33% shall vest on the two-year anniversary of the date of grant. The stock option was approved by our Board of Directors and issued outside of our 2011 Stock Incentive Plan, pursuant to a stock option award agreement with terms substantially similar to those of non-qualified stock options granted under such plan.

University of South Florida License

On August 24, 2012, we secured an exclusive license for specific patented technology from the University of South Florida Research Foundation relating to the delivery of gene-based therapeutics via intratumoral and intramuscular electroporation. This patent directly supports our clinical development focus in solid tumor applications and specifically in metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma using our ImmunoPulse therapy, and extends patent protection for the ImmunoPulse technology to the year 2024.

Old Dominion University Sponsored Research Agreement

On June 4, 2013, we entered into a sponsored research agreement with Old Dominion University and The Frank Reidy Research Center for Bioelectrics (the "ODU SRA"). The intent of the ODU SRA was to pursue some or all of the following goals in furtherance of our operational milestones: (i) to initiate and collaborate on nonclinical research focused on developing new technology related to electroporation and delivery of different agents into solid tumors by electroporation, (ii) to pursue exploratory research to support the development of ImmunoPulse for our melanoma program and other solid tumor malignancies in response to new advances being made in the melanoma field and (iii) to support additional research and development on our electroporation parameters for certain targets. Our initial work order under the ODU SRA was submitted concurrently with our execution of the ODU SRA and we have submitted subsequent work orders for additional research under the ODU SRA since its execution, including during the six month period ended January 31, 2014.

Facility Lease

On May 31, 2013, we entered into a thirty-eight month lease agreement for office space to serve as our corporate headquarters. Our lease commenced on July 1, 2013 and is subject to an initial base monthly rent of approximately $8,000. The lease calls for annual increases to the base rent of three percent.


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Recent Equity Financings

Proceeds from Warrant and Option Exercises

As discussed in more detail in Liquidity and Capital Resources, from February 1, 2014 through March 7, 2014, we have received approximately $7,200,000 in cash from the exercise of warrants and stock options.

September 2013 Public Offering

On September 18, 2013, we closed a registered public offering and issued an aggregate of 47,792,000 shares of our common stock and warrants to purchase an aggregate of 23,896,000 shares of common stock for gross proceeds of approximately $11.95 million (the "September 2013 Public Offering"). The warrants have an exercise price of $0.35 per share, are exercisable immediately upon issuance and have a term of exercise equal to four years from the date of issuance of the warrants. After deducting for fees and expenses, the aggregate net proceeds to us from the sale of the common stock and the warrants in the September 2013 Public Offering were approximately $11.1 million.

In connection with the offering, we paid placement agent fees consisting of
(i) a cash fee equal to 6% of the gross proceeds of the offering, as well as a non-accountable expense allowance equal to 1% of the gross proceeds and
(ii) warrants to purchase up to an aggregate of 5% of the aggregate number of shares of common stock sold in the offering, or 2,389,600 shares of our common stock (the "September 2013 Placement Agent Warrants"). The September 2013 Placement Agent Warrants have substantially the same terms as the warrants issued to the purchasers in the offering, except that such warrants have an exercise price of $0.3125 and expire on September 13, 2018. We intend to use the net proceeds from the September 2013 Public Offering for general corporate purposes, including clinical trial expenses and research and development expenses. As described above and elsewhere in this quarterly report, we made the final payment of $1 million to Inovio in December 2013.

December 2012 Public Offering

On December 17, 2012, we completed a registered public offering of an aggregate of 28,800,000 shares of our common stock and warrants to purchase an aggregate of 14,400,000 shares of common stock for gross proceeds of $7.2 million (the "December 2012 Public Offering"). After deducting for fees and expenses, the aggregate net proceeds to us from the sale of the common stock and the warrants in the December 2012 Public Offering were approximately $6.7 million. In connection with the offering, we paid placement agent fees consisting of (i) a cash fee equal to 6% of the gross proceeds of the offering, as well as a non-accountable expense allowance equal to 1% of the gross proceeds and
(ii) warrants to purchase up to an aggregate of 5% of the aggregate number of shares of common stock sold in the offering, or 1,440,000 shares of our common stock (the "December 2012 Placement Agent Warrants"). The December 2012 Placement Agent Warrants have substantially the same terms as the warrants issued to the purchasers in the offering, except that such warrants have an exercise price of $0.3125 and expire on December 11, 2017.


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March 2012 Public Offering

In March 2012, we completed a registered public offering of an aggregate of 31,000,000 shares of common stock and warrants to purchase an aggregate of 31,000,000 shares of common stock at an aggregate purchase price of $7.75 million (the "March 2012 Public Offering"). After deducting for fees and expenses, the aggregate net proceeds to us from the March 2012 Public Offering were approximately $7.2 million. The warrants issued in the offering have an exercise price of $0.35 per share, are exercisable immediately upon issuance and have a term of exercise equal to five years from the date of issuance of the warrants. In connection with the offering, we paid placement agent fees consisting of (i) a cash fee equal to 6% of the gross proceeds of the offering, as well as a non-accountable expense allowance equal to 1% of the gross proceeds of the offering and (ii) warrants to purchase up to an aggregate of 5% of the aggregate number of shares of common stock sold in the offering, or 1,550,000 shares of common stock (the "March 2012 Placement Agent Warrants"). The March 2012 Placement Agent Warrants have substantially the same terms as the warrants issued to the purchasers in the offering, except that such warrants have an exercise price of $0.3125 and expire on March 23, 2017.

We completed an evaluation of all of the warrants issued in connection with the foregoing offerings and determined the warrants should be classified as equity within our consolidated balance sheets.

Critical Accounting Policies

Accounting for Long-Lived Assets / Intangible Assets

We assess the impairment of long-lived assets, consisting of property and equipment, and finite-lived intangible assets, whenever events or circumstances indicate that the carry value may not be recoverable. Examples of such circumstances include: (1) loss of legal ownership or title to an asset;
(2) significant changes in our strategic business objectives and utilization of the assets; and (3) the impact of significant negative industry or economic trends.

Recoverability of assets to be held and used in operations is measured by a comparison of the carrying amount of an asset to the future net cash flows expected to be generated by the assets. The factors used to evaluate the future net cash flows, while reasonable, require a high degree of judgment and the results could vary if the actual results are materially different than the forecasts. In addition, we base useful lives and amortization or depreciation expense on our subjective estimate of the period that the assets will generate revenue or otherwise be used by us. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less selling costs.

We also periodically review the lives assigned to our intangible assets to ensure that our initial estimates do not exceed any revised estimated periods from which we expect to realize cash flows from the technologies. If a change were to occur in any of the above-mentioned factors or estimates, the likelihood of a material change in our reported results would increase.

Share-Based Compensation

We grant equity-based awards under our share-based compensation plan. We estimate the fair value of share-based payment awards using the Black-Scholes option valuation model. This fair value is then amortized over the requisite service periods of the awards. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. Share-based compensation expense is based on awards ultimately expected to vest, and therefore is reduced by expected forfeitures. Changes in assumptions used under the Black-Scholes option valuation model could materially affect our net loss and net loss per share.


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Results of Operations for the Six Months Ended January 31, 2014 Compared to the Six Months Ended January 31, 2013

The unaudited consolidated financial data for the six month periods ended January 31, 2014 and January 31, 2013 is presented in the following table and the results of these two periods are included in the discussion thereafter.

                                 January 31,    January 31,    Increase/     Increase/
                                    2014           2013        (Decrease)    (Decrease)
                                     ($)            ($)           ($)            %
Revenue                                    -              -             -             -
Operating expenses
Research and development           2,232,955      1,655,212       577,743            35
General and administrative         2,357,318      1,940,107       417,211            22
Loss from operations              (4,590,273 )   (3,595,319 )     994,954            28
Other income (expense)
Interest expense - non-cash
and other                            (20,684 )      (51,594 )     (30,910 )         (60 )
Net loss before income taxes      (4,610,957 )   (3,646,913 )     964,044            26
Tax provision                         40,958          2,000        38,958            **
Net loss                          (4,651,915 )   (3,648,913 )   1,003,002            27


** Percentage increase/(decrease) is greater than 100%.

Operational Milestones and Research and Development Expenses

The $578,000 increase in research and development expenses for the six month period ended January 31, 2014, as compared to the six month period ended January 31, 2013 is primarily the result of increased salary cost and stock-based compensation expense of $238,000 as a result of additional headcount during the period including the appointment of our Chief Medical Officer, increased clinical operations and engineering consulting fees of $160,000 due to an increase in development activity over the comparable period, and $158,000 of costs related to our sponsored research agreement with ODU. We expect research and development expense to continue to increase in future periods as we continue to focus on designing and developing our product candidates.

We expect to continue to use our current funds following our September 2013 Public Offering for the advancement of our operational milestones. Our significant milestones currently include the expansion of our research and development efforts in furtherance of our ImmunoPulse clinical pipeline (our "Clinical Pipeline") and of electroporation devices ("Device R&D"). Specifically, we intend to pursue the following key activities: (i) ongoing product development and execution of clinical trials supporting our Clinical Pipeline; (ii) research related to new product candidates entering into our Clinical Pipeline; and (iii) new Device R&D and support for clinical trials including improvements to existing devices.

Activities related to the above milestones, including aggregate material costs we have incurred or that we estimate to incur during our current fiscal year ending July 31, 2014 ("Fiscal 2014") that are associated with our Clinical Pipeline, include research and clinical trial and related costs of approximately $4,700,000, which are inclusive of plasmid manufacturing costs of approximately $700,000. Material costs we estimate to incur in Fiscal 2014 associated with our Device R&D milestone include salary and related costs of approximately $700,000 and engineering and professional services of approximately $350,000. During the six month period ended January 31, 2014, we incurred approximately $1,342,000 in costs associated with our Clinical Pipeline and approximately $300,000 in costs associated with our Device R&D milestone.

General and Administrative

The $417,000 increase in general and administrative expenses for the six month period ended January 31, 2014, as compared to the six month period ended January 31, 2013, was primarily the result of increased corporate communications and business development costs of approximately $508,000, offset by a decrease in travel and conference fees of $79,000 and $57,000, respectively.

Other Income (Expense)

The $31,000 decrease in other expense for the six-month period ended January 31, 2014, as compared to the comparable six month period ended January 31, 2013, was due to the decrease in non-cash interest expense related to our payment obligations to Inovio pursuant to the Asset Purchase Agreement.


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Liquidity and Capital Resources



Working Capital



Our working capital as of January 31, 2014 and July 31, 2013 is summarized as
follows:



                             At               At
                      January 31, 2014   July 31, 2013
                            ($)               ($)
Current assets              18,778,076       5,169,687
Current liabilities            896,122       1,770,604
Working capital             17,881,954       3,399,083

Current Assets

The increase in our current assets was primarily due to an increase in cash from $4,970,000 as of July 31, 2013, to $18,450,000 as of January 31, 2014, which is attributable to our receipt of approximately $11.1 million in proceeds received from our September 2013 Public Offering and approximately $7.3 million in proceeds received from the cash exercise of warrants, partially offset by cash used in operations during the six month period ended January 31, 2014.

Current Liabilities

Current liabilities as of January 31, 2014 decreased to approximately $896,000, in comparison to our approximate current liabilities of $1,771,000 as of July 31, 2013. This decrease was primarily due to our final payment of $1,000,000 to Inovio in December 2013 pursuant to the Asset Purchase Agreement.

Cash Flow

Cash Used in Operating Activities

Cash used in operating activities for the six month period ended January 31, 2014 was $3,830,000, as compared to $2,593,000 for the six month period ended January 31, 2013. This increase was primarily related to the advancement of our product development and clinical trial pipeline, corporate communications expenses and other general and administrative fees.

Cash Used in Investing Activities

Cash used in investing activities for the six month period ended January 31, 2014 was $55,000, as compared to $3,000 for the six month period ended January 31, 2013. This increase was primarily related to our purchase of property and equipment.

Cash Flow Provided by Financing Activities

Cash provided by financing activities was $17,365,000 for the six month period ended January 31, 2014, as compared to $6,437,000 for the comparable six month period ended January 31, 2013. Our cash provided by financing activities for the six month period ended January 31, 2014 primarily consisted of the proceeds we received from the September 2013 Public Offering as well as cash received from warrant exercise activity during the period.

Equity Financings Since March 2011

In March 2011, we closed a private placement of 1,456,000 units at a purchase price of $0.75 per unit for gross proceeds of $1,092,000 (the "March 2011 Private Placement"). Each unit consisted of one share of our common stock and one share purchase warrant entitling the holder to acquire one share of our common stock at a price of $1.00 per share for a period of five years from the closing of the March 2011 Private Placement. The warrants were exercisable as of March 18, 2011 and any unexercised warrants will expire on March 18, 2016. We completed an evaluation of the warrants issued with this private placement and determined the warrants should be classified as equity within our consolidated balance sheet. We are not obligated to register any of the shares issued or issuable upon exercise of the warrants issued in the March 2011 Private Placement.

On June 24, 2011, we sold in a private placement an aggregate of 4,000,000 shares of our common stock and three series of warrants to purchase an aggregate of 12,000,000 shares of our common stock at a per unit purchase price of $0.75 per unit, for gross proceeds of $3.0 million (the "June 2011 Private Placement"). We also issued warrants to purchase 240,000 shares of our common stock to the co-placement agents in the offering. After deducting for fees and expenses, the aggregate net cash proceeds from the June 2011 Private Placement were approximately $2.79 million.


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Pursuant to the terms of the securities purchase agreement that we entered into . . .

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