Celsion Corporation
Celsion CORP (Form: 10-Q, Received: 08/15/2016 10:21:56)

UNITED STATES  

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2016

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

  

For the transition period from ____________ to ____________

 

Commission file number:  001-15911

 

CELSION CORPORATION

(Exact name of Registrant as specified in its charter) 

 

Delaware       

 

52-1256615       

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification Number)

 

 

 

997 Lenox Drive, Suite 100

Lawrenceville , NJ   08648

(Address of principal executive offices)

 

 

 

(609) 896-9100

(Registrant’s telephone number, including area code)

 

 

 

NA

  (Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.  Yes No

 

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post such files). 

Yes    No

 

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check One):

 

Large accelerated filer

Accelerated filer                 

 

 

Non-accelerated filer     (Do not check if a smaller reporting company)

Smaller reporting company      

 

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). 

Yes       No

 

As of August 12, 2016, the Registrant had 25,810,573 shares of common stock, $0.01 par value per share, outstanding.

 

 

 
 

 

 

CELSION CORPORATION

QUARTERLY REPORT ON

FORM 10-Q

 

TABLE OF CONTENTS

 

  Page(s)

PART I:  FINANCIAL INFORMATION       

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

 

Condensed Consolidated Balance Sheets

  1

 

Condensed Consolidated Statements of Operations

  3

 

Condensed Consolidated Statements of Comprehensive Loss

  4

 

Condensed Consolidated Statements of Cash Flows

  5

 

Notes to Condensed Consolidated Financial Statements

  6

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

  19

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

  29

 

 

 

Item 4.

Controls and Procedures

  30

 

 

 

PART II:  OTHER INFORMATION       

 

 

 

 

Item 1.

Legal Proceedings

  31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

  43

Item 3.

Defaults Upon Senior Securities

  43

Item 4.

Mine Safety Disclosures

  43

Item 5.

Other Information

  43

Item 6.

Exhibits

  44

 

 

 

SIGNATURES       

  45

 

 

 
 i

 

     

Forward-Looking Statements

 

This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are “forward-looking statements” for purposes of this Quarterly Report on Form 10-Q, including, without limitation, any projections of earnings, revenue or other financial items, any statements of the plans and objectives of management for future operations (including, but not limited to, pre-clinical development, clinical trials, manufacturing and commercialization), any statements concerning proposed drug candidates or other new products or services, any statements regarding future economic conditions or performance, any changes in the course of research and development activities and in clinical trials, any possible changes in cost and timing of development and testing, capital structure, financial condition, working capital needs and other financial items, any changes in approaches to medical treatment, any introduction of new products by others, any possible licenses or acquisitions of other technologies, assets or businesses, our ability to realize the full extent of the anticipated benefits of our acquisition of substantially all of the assets of EGEN, Inc., including achieving operational cost savings and synergies in light of any delays we may encounter in the integration process and additional unforeseen expenses, any possible actions by customers, suppliers, partners, competitors and regulatory authorities, compliance with listing standards of The NASDAQ Capital Market and any statements of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or “continue,” or the negative thereof or other comparable terminology. Although we believe that our expectations are based on reasonable assumptions within the bounds of our knowledge of our industry, business and operations, we cannot guarantee that actual results will not differ materially from our expectations.

 

Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including, but not limited to, the risk factors set forth in Part II, Item 1A “Risk Factors” below and for the reasons described elsewhere in this Quarterly Report on Form 10-Q. All forward-looking statements and reasons why results may differ included in this report are made as of the date hereof and we do not intend to update any forward-looking statements, except as required by law or applicable regulations. The discussion of risks and uncertainties set forth in this Quarterly Report on Form 10-Q is not necessarily a complete or exhaustive list of all risks facing us at any particular point in time. We operate in a highly competitive, highly regulated and rapidly changing environment and our business is in a state of evolution. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not possible for management to predict all such risk factors or changes therein, or to assess either the impact of all such risk factors on our business or the extent to which any individual risk factor, combination of factors, or new or altered factors, may cause results to differ materially from those contained in any forward-looking statement.

 

Except where the context otherwise requires, in this Quarterly Report on Form 10-Q, the “Company,” “Celsion,” “we,” “us,” and “our” refer to Celsion Corporation, a Delaware corporation, its wholly-owned subsidiaries CLSN Laboratories, Inc., also a Delaware corporation, and Celsion GmbH, a limited liability company in Zug Switzerland.

 

Trademarks

 

The Celsion brand and product names, including but not limited to Celsion®, ThermoDox®, EGEN®, TheraPlas™ and TheraSilence™, contained in this document are trademarks, registered trademarks or service marks of Celsion Corporation or its subsidiary in the United States (U.S.) and certain other countries. This document also contains references to trademarks and service marks of other companies that are the property of their respective owners.

   

 

 
 ii

 

     

PART I: FINANCIAL INFORMATION

 

Item 1.    FINANCIAL STATEMENTS   

 

CELSION CORPORATION   

 

CONDENSED CONSOLIDATED  

BALANCE SHEETS

    

   

June 30,

2016

(unaudited)

   

December 31,

2015

 

ASSETS

               
                 

Current assets:

               

Cash and cash equivalents

  $ 12,307,789     $ 9,265,144  

Investment securities – available for sale, at fair value

    2,160,000       10,799,890  

Accrued interest receivable on investment securities

    21       26,729  

Advances, deposits and other current assets

    500,775       189,553  

Subtotal current assets

    14,968,585       20,281,316  
                 

Property and equipment (at cost, less accumulated depreciation and amortization of $2,298,483 and $2,058,483, respectively)

    657,630       854,872  
                 

Other assets:

               

In-process research and development

    25,801,728       25,801,728  

Goodwill

    1,976,101       1,976,101  

Security deposit on letter of credit

    100,000       100,000  

Patent licensing fees and other assets, net

    10,636       14,386  

Subtotal other assets

    27,888,465       27,892,215  
                 

Total assets

  $ 43,514,680     $ 49,028,403  

 

See accompanying notes to the financial statements.

 

 

 
1

 

 

CELSION CORPORATION

 

CONDENSED CONSOLIDATED

BALANCE SHEETS

(Continued)

 

   

June 30,

2016

(unaudited)

   

December 31,

2015

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

               
                 

Current liabilities:

               

Accounts payable ─ trade

  $ 2,949,152     $ 2,830,227  

Other accrued liabilities

    2,378,544       1,919,769  

Notes payable - current portion

    4,578,650       4,073,716  

Deferred revenue – current portion

    500,000       500,000  

Total current liabilities

    10,406,346       9,323,712  
                 

Notes payable – non-current portion

    -       2,350,018  

Earn-out milestone liability

    13,815,384       13,921,412  

Deferred revenue – non-current portion

    2,750,000       3,000,000  

Other liabilities – non-current

    30,881       47,597  

Total liabilities

    27,002,611       28,642,739  
                 

Commitments and contingencies

    -       -  
                 

Stockholders’ equity:

               

Preferred Stock - $0.01 par value (100,000 shares authorized and no shares issued or outstanding at June 30, 2016 and December 31, 2015, respectively)

    -       -  

Common stock - $0.01 par value (112,500,000 shares authorized; 25,833,493 and 23,395,211 shares issued at June 30, 2016 and December 31, 2015, respectively and 25,780,554 and 23,319,287 shares outstanding at June 30, 2016 and December 31, 2015, respectively)

    258,335       233,952  

Additional paid-in capital

    245,972,736       239,668,235  

Accumulated other comprehensive loss

    -       (3,858

)

Accumulated deficit

    (228,755,172

)

    (218,130,360

)

Subtotal

    17,475,899       21,767,969  

Treasury stock, at cost (52,939 and 75,924 shares at June 30, 2016 and December 31, 2015, respectively)

    (963,830

)

    (1,382,305

)

Total stockholders’ equity

    16,512,069       20,385,664  
                 

Total liabilities and stockholders’ equity

  $ 43,514,680     $ 49,028,403  

 

See accompanying notes to the financial statements .

  

 

 
2

 

 

CELSION CORPORATION

 

CONDENSED CONSOLIDATED

STATEMENTS OF OPERATIONS

(Unaudited)

 

   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
   

201 6

   

2015

   

201 6

   

2015

 
                                 

Licensing revenue

  $ 125,000     $ 125,000     $ 250,000     $ 250,000  
                                 

Operating expenses:

                               

Research and development

    3,336,372       3,567,699       6,777,543       8,074,107  

General and administrative

    1,529,305       1,801,843       3,391,830       3,833,683  

Total operating expenses

    4,865,677       5,369,542       10,169,373       11,907,790  
                                 

Loss from operations

    (4,740,677

)

    (5,244,542

)

    (9,919,373

)

    (11,657,790

)

                                 

Other income (expense):

                               

Gain (loss) from change in valuation of earn-out milestone liability

    408,684       (69,392

)

    106,028       (241,528

)

Loss from change in valuation of common stock warrant liability

    -       (18,018

)

    -       (61,246

)

Investment income, net

    4,358       16,865       13,699       33,245  

Interest expense

    (203,353

)

    (360,259

)

    (447,551

)

    (752,562

)

Other income (expense)

    5       601       (253

)

    68  

Total other income (expense), net

    209,694       (430,203

)

    (328,077

)

    (1,022,023

)

                                 

Net loss

  $ (4,530,983

)

  $ (5,674,745

)

  $ (10,247,450

)

  $ (12,679,813

)

                                 

Net loss per common share

                               

Basic and diluted

  $ (0.19

)

  $ (0.27

)

  $ (0.43

)

  $ (0.62

)

                                 

Weighted average shares outstanding

                               

Basic and diluted

    24,124,052       20,969,821       23,752,258       20,477,344  

 

See accompanying notes to the financial statements.

 

 

 
3

 

 

CELSION CORPORATION

 

 CONDENSED CONSOLIDATED

STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

 

   

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
   

201 6

   

201 5

   

201 6

   

201 5

 

Other comprehensive (loss) gain

                               
                                 

Changes in:

                               

Realized loss on investment securities recognized in investment income, net

    -     $ 339     $ 3,858     $ 210  

Unrealized gain on investment securities

    -       3,300       -       11,507  
                                 

Other comprehensive gain

    -       3,639       3,858       11,717  
                                 

Net loss

    (4,530,983

)

    (5,674,745

)

    (10,247,450

)

    (12,679,813

)

                                 

Comprehensive loss

  $ (4,530,983

)

  $ (5,671,106     $ (10,243,592

)

  $ (12,668,096

)

 

See accompanying notes to the financial statements.

 

 

 
4

 

 

CELSION CORPORATION

  

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

(Unaudited)

 

   

Six Months Ended

June 30 ,

 
   

2016

   

2015

 

Cash flows from operating activities:

               

Net loss

  $ (10,247,450

)

  $ (12,679,813

)

Non-cash items included in net loss:

               

Depreciation and amortization

    243,750       219,750  

Change in fair value of common stock warrant liability

          61,246  

Change in fair value of earn-out milestone liability

    (106,028

)

    241,528  

Deferred revenue

    (250,000

)

    (250,000

)

Stock-based compensation costs

    898,520       1,310,081  

Shares issued out of treasury

    41,113       52,027  

Amortization of deferred finance charges and debt discount associated with notes payable

    145,586       245,230  

Change in deferred rent liability

    (16,716

)

    (13,999

)

Loss realized on sale of investment securities

    3,858       210  

Net changes in:

               

Accrued interest on short term investments

    26,708       158,265  

Advances, deposits and other current assets

    (311,222

)

    (248,363

)

Accounts payable

    118,925       (486,460

)

Accrued liabilities

    458,775       (220,399

)

Net cash (used in) operating activities:

    (8,994,181

)

    (11,610,697

)

                 

Cash flows from investing activities:

               

Purchases of investment securities

    (2,160,000

)

    (15,487,755

)

Proceeds from sale and maturity of investment securities

    10,799,890       20,894,325  

Refund of security deposit on letter of credit

          50,000  

Purchases of property and equipment

    (42,758

)

    (54,911

)

Net cash provided by investing activities

    8,597,132       5,401,659  
                 

Cash flows from financing activities:

               

Proceeds from sale of common stock equity, net of issuance costs

    5,430,364       7,249,750  

Principal payments on notes payable

    (1,990,670

)

    (1,776,602

)

Net cash provided by financing activities

    3,439,694       5,473,148  
                 

Increase (decrease) in cash and cash equivalents

    3,042,645       (735,890

)

Cash and cash equivalents at beginning of period

    9,265,144       12,686,881  

Cash and cash equivalents at end of period

  $ 12,307,789     $ 11,950,991  
                 

Supplemental disclosures of cash flow information:

               

Interest paid

  $ 301,996     $ 507,332  

 

See accompanying notes to the financial statements.

 

 

 
5

 

 

CELSION CORPORATION

  

 NOTES TO THE CONDENSED CONSOLIDATED

  FINANCIAL STATEMENTS (UNAUDITED)

 

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2016 AND 2015

  

 

Note 1.   Business Description

 

Celsion Corporation, a Delaware corporation based in Lawrenceville, New Jersey, its wholly-owned subsidiaries CLSN Laboratories, Inc., also a Delaware corporation, and Celsion GmbH, a limited liability company in Zug Switzerland, referred to herein as “Celsion”, “we”, or “the Company,” as the context requires, is a fully-integrated oncology drug development company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. Our lead program is ThermoDox ® , a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. Our pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. We have three platform technologies for the development of treatments for those suffering with difficult-to-treat forms of cancer, novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™. We are working to develop and commercialize more efficient, effective and targeted oncology therapies based on our technologies, with the goal to develop novel therapeutics that maximize efficacy while minimizing side effects common to cancer treatments.

   

 

Note 2.   Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements, which include the accounts of Celsion Corporation, CLSN Laboratories, Inc. and Celsion GmbH, have been prepared in accordance with generally accepted accounting principles in the United States (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  All intercompany balances and transactions have been eliminated. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations.

 

In the opinion of management, all adjustments, consisting only of normal recurring accruals considered necessary for a fair presentation, have been included in the accompanying unaudited condensed consolidated financial statements. Operating results for the three and six month periods ended June 30, 2016 are not necessarily indicative of the results that may be expected for any other interim period(s) or for any full year. For further information, refer to the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K and Form 10K/A for the fiscal year ended December 31, 2015 filed with the Securities and Exchange Commission (SEC) on March 30, 2016 and April 29, 2016, respectively.

 

The preparation of financial statements in conformity with GAAP requires management to make judgments, estimates, and assumptions that affect the amount reported in the Company’s financial statements and accompanying notes.  Actual results could differ materially from those estimates. Events and conditions arising subsequent to the most recent balance sheet date have been evaluated for their possible impact on the financial statements and accompanying notes.  No events and conditions would give rise to any information that required accounting recognition or disclosure in the financial statements other than those arising in the ordinary course of business. 

     

Note 3.    Management’s Plan

 

The Company has incurred an accumulated deficit of $229 million through June 30, 2016. In addition, the Company has incurred negative cash flow from operations since it started the business. The Company has spent, and expects to continue to spend, substantial amounts in connection with implementing its business strategy, including the planned product development efforts, clinical trials, and research and discovery efforts.

 

The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond the Company’s control. These factors include the following:

 

 

the progress of research activities;

 

the number and scope of research programs;

 

the progress of preclinical and clinical development activities;

 

the progress of the development efforts of parties with whom the Company has entered into research and development agreements;

 

 

 
6

 

       

 

the costs associated with additional clinical trials of product candidates;

 

the ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements;

 

the ability to achieve milestones under licensing arrangements;

 

the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

 

the costs and timing of regulatory approvals.

 

The Company has based its estimate on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater amounts than it currently anticipates. Potential sources of financing include strategic relationships, public or private sales of the Company’s shares or debt and other sources.

 

The Company may seek to access the public or private equity markets when conditions are favorable due to long-term capital requirements. As more fully discussed in Note 11, the Company has $7.5 million available under a controlled equity offering facility it has with Cantor Fitzgerald & Co. Besides this equity facility, the Company does not have any committed sources of financing at this time, and it is uncertain whether additional funding will be available when needed on terms that will be acceptable to it, or at all. If the Company raises funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of the existing stockholders will be diluted. If the Company is not able to obtain financing when needed, it may be unable to carry out the business plan. As a result, the Company may have to significantly limit its operations and its business, financial condition and results of operations would be materially harmed.

   

 

Note 4.   New Accounting Pronouncements

 

From time to time, new accounting pronouncements are issued by Financial Accounting Standards Board (FASB) and are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to our operations.

 

In April 2015, the FASB issued Accounting Standards Update No. 2015-03 Interest – Imputation of Interest (ASU Subtopic 835-30). The new standard requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. ASU Subtopic 835-30 became effective for the Company beginning January 1, 2016 and was applied retrospectively. This adoption resulted in the reclassification of unamortized deferred financing fees related to the Company’s notes payable from other assets totaling $11,731 and $26,131 as of June 30, 2016 and December 31, 2015, respectively.

 

In January 2016, the FASB issued Accounting Standards Update No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, which requires that most equity investments be measured at fair value, with subsequent changes in fair value recognized in net income (other than those accounted for under equity method of accounting). This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statements and disclosures.

  

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (Topic 842), which requires lessees recognize assets and liabilities for leases with lease terms greater than twelve months in the statement of financial position. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. This update also requires improved disclosures to help users of financial statements better understand the amount, timing and uncertainty of cash flows arising from leases. The update is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that reporting period. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance will have on its consolidated financial statements and disclosures.

 

In March 2016, the FASB issued Accounting Standards Update No 2016-09, Compensation – Stock Compensation (Topic 718). The new standard simplifies several aspects of the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The new standard is effective for public companies for annual reporting periods beginning after December 15, 2016, including interim periods within those annual reporting periods; however, early adoption is allowed. The Company is currently evaluating the impact of the pending adoption of the new standard on the Company’s consolidated financial statements.

 

 

 
7

 

     

Note 5.   Net Loss per Common Share

 

Basic earnings per share is calculated based upon the net income (loss) available to common shareholders divided by the weighted average number of common shares outstanding during the period.  Diluted earnings per share is calculated after adjusting the denominator of the basic earnings per share computation for the effects of all dilutive potential common shares outstanding during the period. The dilutive effects of preferred stock, options and warrants and their equivalents are computed using the treasury stock method.  

 

For the three and six month periods ended June 30, 2016, the total number of shares of common stock issuable upon exercise of warrants and equity awards was 19,534,061. The Pre-funded Series B Warrants (as more fully described in Note 11 of these financial statements) convertible into shares of the Company’s common stock totaling 2,100,000 are considered issued in calculating basic loss per share. For the three and six month periods ended June 30, 2016, diluted loss per common share was the same as basic loss per common share as the other 17,434,061 warrants and equity awards that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted earnings per common share as their effect would have been anti-dilutive.

 

The total number of shares of common stock issuable upon exercise of warrants and equity awards were 8,188,708 for the three and six month periods ended June 30, 2015. For the three and six month periods ended June 30, 2015, diluted loss per common share was the same as basic loss per common share as all options and all warrants that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted earnings attributable to common shareholders per common share as their effect would have been anti-dilutive.

     

Note 6.   Investment Securities - Available For Sale

 

Short term investments available for sale of $2,160,000 and $10,799,890 as of June 30, 2016 and December 31, 2015 consist of certificates of deposit and corporate debt securities. They are valued at estimated fair value, with unrealized gains and losses reported as a separate component of stockholders’ equity in Accumulated Other Comprehensive Income.

 

Securities available for sale are evaluated periodically to determine whether a decline in their value is other than temporary.  The term “other than temporary” is not intended to indicate a permanent decline in value.  Rather, it means that the prospects for near term recovery of value are not necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security.  Management reviews criteria such as the magnitude and duration of the decline, as well as the reasons for the decline, to predict whether the loss in value is other than temporary.  Once a decline in value is determined to be other than temporary, the value of the security is reduced and a corresponding charge to earnings is recognized.  

 

A summary of the cost, fair value and maturities of the Company’s short-term investments is as follows:

 

   

June 30, 2016

   

December 31, 2015

 
   

Cost

   

Fair Value

   

Cost

   

Fair Value

 

Short-term investments

                               

Certificate of deposit

  $ 2,160,000     $ 2,160,000     $ 4,800,000     $ 4,798,810  

Corporate debt securities

                6,003,748       6,001,080  

Total

  $ 2,160,000     $ 2,160,000     $ 10,803,748     $ 10,799,890  

 

   

June 30, 2016

   

December 31, 2015

 
   

Cost

   

Fair Value

   

Cost

   

Fair Value

 
                                 

Short-term investment maturities

                               

Within 3 months

  $     $     $ 10,803,748     $ 10,799,890  

Between 3-12 months

    2,160,000     $ 2,160,000              

Total

  $ 2,160,000     $ 2,160,000     $ 10,803,748     $ 10,799,890  

 

Investment income, which includes net realized losses on sales of available for sale securities and investment income interest and dividends, is summarized as follows:

 

   

Three Months Ended June 30,

 

Description of Securities

 

2016

   

2015

 
                 

Interest and dividends accrued and paid

  $ 4,358     $ 38,772  

Accretion of investment premium

          (21,568

)

Realized (losses) gains

          (339

)

Investment income, net

  $ 4,358     $ 16,865  

  

 

 
8

 

 

   

Six Months Ended June 30,

 

Description of Securities

 

2016

   

2015

 
                 

Interest and dividends accrued and paid

  $ 23,345     $ 131,974  

Accretion of investment premium

    (5,788

)

    (98,519

)

Realized (losses) gains

    (3,858

)

    (210

)

Investment income, net

  $ 13,699     $ 33,245  

 

The following table shows the Company’s investment securities gross unrealized losses and fair value by investment category and length of time that individual securities have been in a continuous unrealized loss position at June 30, 2016. The Company has reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary.

 

   

June 30, 2016

   

December 31, 2015

 

Description of Securities

 

Fair Value

   

Unrealized

Holding

Gains

(Losses)

   

Fair Value

   

Unrealized

Holding

Gains

(Losses)

 
                                 

Available for Sale (all unrealized holding gains and losses are less than 12 months at date of measurement)

                               

Short-term investments with unrealized gains

  $ 2,160,000     $     $ 240,024     $ 24  

Short-term investments with unrealized losses

                10,559,866       (3,882

)

Total

  $ 2,160,000     $     $ 10,799,890     $ (3,858

)

  

The following table presents the change, by component, in accumulated other comprehensive loss for the first six months of 2016.  

 

Accumulated Other Comprehensive Loss

       

Balance at January 1, 2016

  $ (3,858

)

         

Realized loss reclassified from other accumulated comprehensive loss

    3,858  

Other comprehensive gain, net

    3,858  
         

Balance at June 30, 2016

  $  

     

Note 7.   Fair Value of Measurements

 

FASB Accounting Standards Codification (ASC) Section 820 “ Fair Value Measurements and Disclosures,” establishes a three level hierarchy for fair value measurements which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of inputs that may be used to measure fair value are as follows:  

 

Level 1 : Quoted prices (unadjusted) or identical assets or liabilities in active markets that the entity has the ability to access as of the measurement date;

 

Level 2 : Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data; and

 

Level 3 : Significant unobservable inputs that reflect a reporting entity’s own assumptions that market participants would use in pricing an asset or liability.

 

The fair values of securities available for sale are determined by obtaining quoted prices on nationally recognized exchanges (Level 1 inputs) or matrix pricing, which is a mathematical technique widely used in the industry to value debt securities without relying exclusively on quoted prices for the specific securities but rather by relying on the securities’ relationship to other benchmark quoted securities (Level 2 inputs).

  

 

 
9

 

 

Cash and cash equivalents, other current assets, accounts payable and other accrued liabilities are reflected in the balance sheet at their estimated fair values primarily due to their short-term nature. There were no transfers of assets of liabilities between Level 1 and Level 2 and no transfers in or out of Level 3 during the six months ended June 30, 2016 except for the change in the earn-out milestone liability included in earnings (Note 13).

 

Assets and liabilities measured at fair value are summarized below:

 

   

Total Fair

Value on

the

Balance

Sheet

   

Quoted

Prices

In Active

Markets

For

Identical

Assets

/Liabilities

(Level 1)

   

Significant

Other

Observable

Inputs

(Level 2)

   

Significant

Unobservable

Inputs

(Level 3)

 

Assets:

                               

Recurring items as of June 30, 2016

                               

Short-term investments available for sale

  $ 2,160,000     $ 2,160,000       -       -  
                                 

Recurring items as of December 31, 2015

                               

Short-term investments available for sale

  $ 10,799,890     $ 10,799,890       -       -  
                                 

Liabilities:

                               

Recurring items as of June 30, 2016

                               

Earn-out milestone liability (Note 13)

  $ 13,815,384       -       -     $ 13,815,384  
                                 

Recurring items as of December 31, 2015

                               

Earn-out milestone liability (Note 13)

  $ 13,921,412       -       -     $ 13,921,412  

   

 

Note 8.   Acquisition of EGEN, Inc.

 

On June 20, 2014, we completed the acquisition of substantially all of the assets of EGEN, Inc., an Alabama Corporation (EGEN) pursuant to an Asset Purchase Agreement (EGEN Purchase Agreement). We acquired all of EGEN’s right, title and interest in and to substantially all of the assets of EGEN, including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits, equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. In addition, we assumed certain specified liabilities of EGEN, including the liabilities arising out of the acquired contracts and other assets relating to periods after the closing date.

 

The total aggregate purchase price for the acquisition is up to $44.4 million, which includes potential future payments of up to $30.4 million contingent upon achievement of certain milestones set forth in the EGEN Purchase Agreement (Earn-out Payments). At the closing, we paid approximately $3.0 million in cash after expense adjustment and issued 2,712,188 shares of its common stock to EGEN. In addition, 670,070 shares of common stock are currently issuable to EGEN pending satisfactory resolution of any post-closing adjustments of expenses and EGEN’s indemnification obligations under the EGEN Purchase Agreement (Holdback Shares).

  

The Earn-out payments of up to $30.4 million will become payable, in cash, shares of Celsion common stock or a combination thereof, at Celsion’s option, as follows:  

  

$12.4 million will become payable upon achieving certain specified development milestones relating to an ovarian cancer study of GEN-1 to be conducted by the Company or its subsidiary;

   

$12.0 million will become payable upon achieving certain specified development milestones relating to a GEN-1 glioblastoma multiforme brain cancer study to be conducted by us or our subsidiary; and

   

up to $6.0 million will become payable upon achieving certain specified milestones relating to the TheraSilence TM technology acquired from EGEN in the acquisition.

 

 

 
10

 

   

The acquisition of EGEN was accounted for under the acquisition method of accounting which required the Company to perform an allocation of the purchase price to the assets acquired and liabilities assumed. The fair value of the consideration transferred for the acquisition was approximately $27.6 million. Under the acquisition method of accounting, the total purchase price was allocated to EGEN’s net tangible and intangible assets and liabilities based on their estimated fair values as of the acquisition date. The following table summarizes the fair values of these assets acquired and liabilities assumed related to the acquisition.

 

Property and equipment, net

  $ 35,000  

In-process research and development

    25,802,000  

Goodwill

    1,976,000  

Total assets:

    27,813,000  

Accounts payable and accrued liabilities

    (235,000

)

Net assets acquired

  $ 27,578,000  

 

Acquired In-Process Research and Development (IPR&D) consists of EGEN's drug technology platforms: TheraPlas and TheraSilence . The fair value of the IPR&D drug technology platforms was estimated to be $25.8 million as of the acquisition date. As of the closing of the acquisition, the IPR&D is considered indefinite lived intangible assets and will not be amortized. IPR&D is reviewed for impairment at least annually as of our third quarter ended September 30, and whenever events or changes in circumstances indicate that the carrying value of the assets might not be recoverable. As of September 30, 2015, after our assessment of the totality of the events that could impair IPR&D, it is the Company’s conclusion “it is not more likely than not” that the indefinite-lived intangible assets are impaired. Therefore, the Company is not required to calculate the fair value of the intangible assets and perform a quantitative impairment test. No events have occurred as of June 30, 2016 that would affect the Company’s conclusion as of its assessment date.

 

The purchase price exceeded the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as Goodwill. Goodwill represents the difference between the total purchase price for the net assets purchased from EGEN and the aggregate fair values of tangible and intangible assets acquired, less liabilities assumed. Goodwill is reviewed for impairment at least annually as of our third quarter ended September 30 or sooner if we believe indicators of impairment exist. As of September 30, 2015, after our assessment of the totality of the events that could impair Goodwill, it is the Company’s conclusion “it is not more likely than not” that the Goodwill is impaired. Therefore, the Company is not required to conduct a two-step quantitative goodwill impairment test. No events have occurred as of June 30, 2016 that would affect the Company’s conclusion as of the September 30, 2015 assessment date.

   

 

Note 9.  Accrued Liabilities

 

Other accrued liabilities at June 30, 2016 and December 31, 2015 include the following:

 

   

June 30,

2016

   

December 31,

2015

 

Amounts due to contract research organizations and other contractual agreements

  $ 1,043,584     $ 571,615  

Accrued payroll and related benefits

    878,984       947,078  

Accrued professional fees

    394,500       319,200  

Accrued interest on notes payable

    41,736       62,136  

Other

    19,740       19,740  

Total

  $ 2,378,544     $ 1,919,769  

     

Note 10.   Note Payable

 

In November 2013, the Company entered into a loan agreement with Hercules Technology Growth Capital, Inc. (Hercules) which permits up to $20 million in capital to be distributed in multiple tranches (the Hercules Credit Agreement). The Company drew the first tranche of $5 million upon closing of the Hercules Credit Agreement in November 2013 and used approximately $4 million of the proceeds to repay the outstanding obligations under its loan agreement with Oxford Finance LLC and Horizon Technology Finance Corporation as discussed further below. On June 10, 2014, the Company closed the second $5 million tranche under the Hercules Credit Agreement. The proceeds were used to fund the $3.0 million upfront cash payment associated with Celsion's acquisition of EGEN, as well as the Company’s transaction costs associated with the EGEN acquisition.  Upon the closing of this second tranche, the Company has drawn down a total of $10 million under the Hercules Credit Agreement. 

   

 

 
11

 

 

The obligations under the Hercules Credit Agreement are in the form of secured indebtedness bearing interest at a calculated prime-based variable rate (11.25% per annum since inception through December 17, 2015 and 11.50% since). Payments under the loan agreement were interest only for the first twelve months after loan closing, followed by a 30-month amortization period of principal and interest through the scheduled maturity date of June 1, 2017.

 

In connection with the Hercules Credit Agreement, the Company incurred cash expenses of $122,378 which were recorded as deferred financing fees.  These deferred financing fees are being amortized as interest expense using the effective interest method over the life of the loan.  In connection with adoption of ASU Subtopic 835-30 during the first quarter of 2016, unamortized deferred financing fees of $11,731 and $26,131 as of June 30, 2016 and December 31, 2015, respectively, have been classified as a direct deduction from the debt liability consistent with the presentation of a debt discount. Also in connection with the Hercules Credit Facility, the Company paid loan origination fees of $230,000 which has been classified as debt discount. This amount is being amortized as interest expense using the effective interest method over the life of the loan.

 

As a fee in connection with the Hercules Credit Agreement, the Company issued Hercules a warrant for a total of 97,493 shares of the Company’s common stock (the Hercules Warrant) at a per share exercise price of $3.59, exercisable for cash or by net exercise from November 25, 2013. Upon the closing of the second tranche on June 10, 2014, this warrant became exercisable for an additional 97,493 shares of the Company’s common stock. The Hercules Warrant will expire November 25, 2018. Hercules has certain rights to register the common stock underlying the Hercules Warrant pursuant to a Registration Rights Agreement with the Company dated November 25, 2013. The registration rights expire on the date when such stock may be sold under Rule 144 without restriction or upon the first year anniversary of the registration statement for such stock, whichever is earlier. The common stock issuable pursuant to the Hercules Warrant was filed pursuant to Rule 415 under the Securities Act of 1933 on the Prospectus for Registration Statement No. 333-193936 and was declared effective on September 30, 2014. The Company valued the Hercules Warrant issued at the inception of the loan using the Black-Scholes option pricing model and recorded $521,763 in 2013 as deferred financing fees.  In calculating the value of the warrants, the Company assumed a volatility rate of 102%, risk free interest rate of 1.37%, an expected life of 5 years, a stock price of $3.55 (closing price on date of the Hercules Warrant) and no expected forfeitures nor dividends.  In the second quarter of 2014, the Company reassessed the classification of the warrants and concluded the original amount should be reclassified from deferred financing fees and equity. Therefore, other assets and additional paid in capital were both reduced by the $521,763. The Company then valued the warrant for the initial 97,493 shares of the Company’s common stock as of the inception of the loan and recorded $260,928 as a debt discount to be amortized as interest expense using the effective interest method over the life of the loan and recognized a warrant liability for this amount. In connection with the closing of the second $5 million tranche on June 9, 2014, the Company then valued the warrant for the additional 97,493 shares of the Company’s common stock which became available and exercisable as of the date and recorded $215,333 as a debt discount to be amortized as interest expense using the effective interest method over the life of the loan and recognized a warrant liability for this amount. In calculating the value of the warrant for the additional shares of the Company’s common stock on June 10, 2014, the Company assumed a volatility rate of 104%, risk free interest rate of 1.69%, an expected remaining life of 4.5 years, a stock price of $3.07 (closing price June 9, 2014) and no expected forfeitures nor dividends.  In 2014, the warrant liability was fair valued at the end of each quarter and the resulting change in fair value will be recognized in net income. In the second quarter of 2015, the Company concluded the warrant provision which provided for the exercise price to be adjusted downward as described above had expired. Therefore, the Company valued the warrant at $336,254 immediately prior to this event and recorded non-cash charges to net income of $18,018 and $61,246 in the second quarter and year to date periods of 2015, respectively. The Company also reduced the liability to zero and increased equity by $336,254 at this time. Also in connection with each of the $5.0 million tranches, the Company will be required to pay an end of term charge equal to 3.5% of each original loan amount at time of maturity. Therefore, these amounts totaling $350,000 are being amortized as interest expense using the effective interest method over the life of the loan.

 

For the three month periods ended June 30, 2016 and 2015, the Company incurred $136,439 and $242,421 in interest expense, respectively, and amortized $66,914 and $117,838, respectively as interest expense for deferred fees, debt discount and end of term charges in connection with the Hercules Credit Agreement. For the six month periods ended June 30, 2016 and 2015, the Company incurred $301,966 and $507,332 in interest expense, respectively, and amortized $145,585 and $245,230, respectively, as interest expense for deferred fees, debt discount and end of term charges in connection with the Hercules Credit Agreement.

 

The Hercules Credit Agreement contains customary covenants, including covenants that limit or restrict the Company’s ability to grant liens, incur indebtedness, make certain restricted payments, merge or consolidate and make dispositions of assets. Upon the occurrence of an event of default under the Hercules Credit Agreement, the lenders may cease making loans, terminate the Hercules Credit Agreement, declare all amounts outstanding to be immediately due and payable and foreclose on or liquidate the Company’s assets that comprise the lenders’ collateral. The Hercules Credit Agreement specifies a number of events of default (some of which are subject to applicable grace or cure periods), including, among other things, non-payment defaults, covenant defaults, a material adverse effect on the Company or its assets, cross-defaults to other material indebtedness, bankruptcy and insolvency defaults and material judgment defaults. The Company has maintained compliance with these covenants.

 

 
12

 

 

Total notes payable associated with the Hercules Credit Agreement consisted of the following at:

 

   

June 30,

   

December 31,

 
   

2016

   

2015

 

Principal amount

  $ 4,355,100     $ 6,345,769  

Amortized end of term charges

    235,281       265,859  

Unamortized debt issuance costs

    (11,731

)

    (187,894

)

Total convertible notes payable

  $ 4,578,650     $ 6,423,734  

 

Following is a schedule of future principle payments before debt discount and end of term charges due on the Hercules Credit Agreement:

 

   

For the year ending

June 30,

 

2017

  $ 4,355,100  

2018 and thereafter

     

Total

  $ 4,355,100  

     

Note 11.   Stockholders’ Equity

 

In September 2015, the Company filed with the SEC a $75 million shelf registration statement on Form S-3 (File No. 333-206789) that allows the Company to issue any combination of common stock, preferred stock or warrants to purchase common stock or preferred stock (the 2015 Registration Statement).  This shelf registration was declared effective on September 25, 2015.

 

On June 13, 2016, the Company entered into a Securities Purchase Agreement (the June 2016 Purchase Agreement) with an investor, pursuant to which the Company issued and sold, in a registered direct offering (the June 2016 Offering), an aggregate of 2,311,764 shares of common stock, par value $0.01 per share, of the Company at an offering price of $1.36 per share. In addition, the Company sold Pre-Funded Series B Warrants (the Pre-Funded Series B Warrants) to purchase 2,100,000 shares of common stock (and the shares of common stock issuable upon exercise of the Pre-Funded Series B Warrants), in lieu of shares of common stock to the extent that the purchase of common stock would cause the beneficial ownership of the Purchaser, together with its affiliates and certain related parties, to exceed 9.99% of our common stock. The Company offered these shares and warrants under the June 2016 Purchase Agreement pursuant to the 2015 Registration Statement. The Company received gross proceeds of approximately $6.0 million before the deduction of the placement agent fee and offering expenses in the June 2016 Offering.

 

In a concurrent private placement (the June 2016 Private Placement), the Company issued to the investor Series A warrants (the June 2016 Series A Warrants), each to purchase 0.5 share of common stock, Series C warrants (the June 2016 Series C Warrants), each to purchase one share of common stock, and Series D warrants (the June 2016 Series D Warrants), each to purchase 0.5 share of common stock (collectively the June 2016 Warrants). The June 2016 Series A Warrants are initially exercisable six months following issuance and terminate five and one-half years following issuance. The June 2016 Series C Warrants are initially exercisable six months following issuance and terminate one year following issuance. The June 2016 Series D Warrants only become exercisable ratably upon the exercise of the June 2016 Series C Warrants, are initially exercisable six months following issuance, and terminate five and one-half years following issuance. The June 2016 Warrants have an exercise price of $1.40 per share and are exercisable to purchase an aggregate of 8,823,528 shares of common stock. Subject to limited exceptions, a holder of a June 2016 Warrant will not have the right to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%. The June 2016 Warrants and the shares of our common stock issuable upon the exercise of the June 2016 Warrants are not being registered under the Securities Act of 1933, as amended (the “Securities Act”), are not being offered pursuant to the Registration Statement and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. On July 8, 2016 we filed a registration statement on Form S-3 to provide for the resale of the shares of common stock issuable upon the exercise of the June 2016 Warrants and will be obligated to use our commercially reasonable efforts to keep such registration statement effective until the earliest of (i) the date on which all of the shares of commons stock issuable upon the exercise of the June 2016 Warrants have been sold under the registration statement or Rule 144 under the Securities Act, (ii) the date on which the shares of common stock issuable upon the exercise of the June 2016 Warrants may be sold without volume or manner-of-sale restrictions pursuant to Rule 144 under the Securities Act and (iii) the termination of the June 2016 Warrants.

 

 

 
13

 

 

Under the June 2016 Purchase Agreement, the Company is prohibited, for a period of six months after the closing, from effecting or entering into an agreement to issue common stock or any other securities that are at any time convertible into, or exercisable or exchangeable for, or otherwise entitle the holder thereof to receive, common stock to the extent such issuance or sale involves certain variable conversion, exercise or exchange prices or such agreement provides for sale of securities at a price to be determined in the future.

 

May 2015 C ommon Stock Offering

 

On May 27, 2015, the Company entered into a Securities Purchase Agreement with certain investors, pursuant to which the Company sold and issued on June 1, 2015, in a registered direct offering (the May 2015 Offering), an aggregate of 3,000,000 shares of common stock at an offering price of $2.675 per share for gross proceeds of $8.0 million before the deduction of the placement agent fee and offering expenses. The Shares were offered by the Company pursuant to a registration statement on Form S-3 (File No. 333-183286), which was initially filed with the SEC on August 13, 2012, as amended on August 20, 2012, and was declared effective by the SEC on September 14, 2012 (the Shelf Registration Statement).

 

In a concurrent private placement closed on June 1, 2015, the Company issued to the investors in the May 2015 Offering certain warrants (the May 2015 Warrants) at an exercise price of $2.60 per share. The May 2015 Warrants are exercisable to purchase 0.65 share of common stock for each share of common stock purchased in the May 2015 Offering for an aggregate of 1,950,000 shares of common stock. Each May 2015 Warrant will be exercisable on the date of its issuance until the five-year anniversary of the date of issuance. On July 10, 2015, the Company filed a registration statement for the resale of any shares of common stock issuable upon the exercise of the May 2015 Warrants on Form S-3 (File No. 333-205608) which was declared effective by the SEC on July 30, 2015.

 

Under this purchase agreement, the Company was prohibited, for the period from the date of closing and ending September 1, 2015, from effecting or entering into an agreement to issue common stock or, for a period of five months after the closing, any other securities that are at any time convertible into, or exercisable or exchangeable for, or otherwise entitle the holder thereof to receive, common stock to the extent such issuance or sale involves certain variable conversion, exercise or exchange prices or such agreement provides for sale of securities at a price to be determined in the future.

 

Controlled Equity Offering

 

On February 1, 2013, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “ATM Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which Celsion may offer and sell, from time to time, through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (the “ATM Shares”) pursuant to the Company’s previously filed and effective Registration Statement on Form S-3. Under the ATM Agreement, Cantor may sell ATM Shares by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The NASDAQ Capital Market, on any other existing trading market for the our common stock or to or through a market maker.  From February 1, 2013 through June 30, 2016, the Company sold and issued an aggregate of 1,479,535 shares of common stock under the ATM Agreement, receiving approximately $7.4 million in net proceeds.

  

The Company is not obligated to sell any ATM Shares under the ATM Agreement.  Subject to the terms and conditions of the ATM Agreement, Cantor will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of The NASDAQ Capital Market, to sell ATM Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may impose. In addition, pursuant to the terms and conditions of the ATM Agreement and subject to the instructions of the Company, Cantor may sell ATM Shares by any other method permitted by law, including in privately negotiated transactions.

  

The ATM Agreement will terminate upon the earlier of (i) the sale of ATM Shares under the ATM Agreement having an aggregate offering price of $25 million and (ii) the termination of the ATM Agreement by Cantor or the Company. The ATM Agreement may be terminated by Cantor or the Company at any time upon 10 days' notice to the other party, or by Cantor at any time in certain circumstances, including the occurrence of a material adverse change in the Company.  The Company pays Cantor a commission of 3.0% of the aggregate gross proceeds from each sale of ATM Shares and has agreed to provide Cantor with customary indemnification and contribution rights. The Company also reimbursed Cantor for legal fees and disbursements of $50,000 in connection with entering into the ATM Agreement. On October 2, 2015, we filed a prospectus supplement to the base prospectus that forms a part of the Shelf Registration Statement, filed on September 4, 2015 and declared effective by the SEC on September 25, 2015, pursuant to which we may offer and sell up to $7,500,000 of common stock from time to time under the ATM Agreement. The Company currently has approximately $17.4 million remaining under the ATM Agreement.

 

 

 
14

 

     

Note 12.   Stock Based Compensation

 

Stock Options Plans

 

The Company has long-term compensation plans that permit the granting of incentive awards in the form of stock options. Generally, the terms of these plans require that the exercise price of the options may not be less than the fair market value of Celsion’s common stock on the date the options are granted. Options granted generally vest over various time frames or upon milestone accomplishments.  The Company’s options generally expire ten years from the date of the grant.

 

In 2007, the Company adopted the Celsion Corporation 2007 Stock Incentive Plan (the 2007 Plan) under which 222,222 shares were authorized for issuance. The purpose of the 2007 Plan is to promote the long-term growth and profitability of the Company by providing incentives to improve stockholder value and enable the Company to attract, retain and reward the best available persons for positions of substantial responsibility.  The 2007 Plan permits the granting of equity awards in the form of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, phantom stock, and performance awards, or in any combination of the foregoing.  At the Annual Meetings of Stockholders of Celsion held on June 25, 2010, June 7, 2012 and June 20, 2014, the stockholders approved amendments to the Plan.  The only material difference between the original Plan and the amended Plan was the number of shares of common stock available for issuance under the amended Plan which was increased by 222,222 to a total of 444,444 shares in 2010, by 500,000 to a total of 944,444 shares in 2012 and by 2,500,000 to a total of 3,444,444 shares in 2014.

 

Prior to the adoption of the 2007 Plan, the Company adopted two stock plans for directors, officers and employees (one in 2001 and another in 2004) under which 148,148 shares were reserved for future issuance under each of these plans.  As these plans have been superseded by the 2007 Plan, any options previously granted which expire, forfeit, or cancel under these plans will be rolled into the 2007 Plan.

 

A summary of the Company’s stock option and restricted stock awards for the six months ended June 30, 2016 is as follows: 

 

   

Stock Options

   

Restricted Stock

Awards

   

Weighted

Average

 

Equity Awards

 

Options

Outstanding

   

Weighted

Average

Exercise

Price

   

Non-vested

Restricted

Stock

Outstanding

   

Weighted

Average

Grant

Date

Fair Value

   

Contractual

Terms of

Equity

Awards

(in years)

 
                                         

Equity awards outstanding at December 31, 2015

    2,139,822     $ 5.64       81,518     $ 2.64          

Equity awards granted

    551,250     $ 1.33       110,000     $ 1.63          

Equity awards exercised

                (126,518

)

  $ 1.72          

Equity awards forfeited, cancelled or expired

    (40,214

)

  $ 12.36                      
                                         

Equity awards outstanding at June 30, 2016

    2,650,858     $ 4.64       65,000     $ 2.72       7.4  
                                         

Aggregate intrinsic value of outstanding awards at June 30, 2016

  $             $ 176,611                  
                                         

Equity awards exercisable at June 30, 2016

    1,909,979     $ 5.69                       7.0  
                                         

Aggregate intrinsic value of awards exercisable at June 30, 2016

  $                                  

 

The fair values of stock options granted were estimated at the date of grant using the Black-Scholes option pricing model. The Black-Scholes model was originally developed for use in estimating the fair value of traded options, which have different characteristics from Celsion’s stock options. The model is also sensitive to changes in assumptions, which can materially affect the fair value estimate.  

 

 

 
15

 

 

The Company used the following assumptions for determining the fair value of options granted under the Black-Scholes option pricing model:

 

   

Six Months Ended June 30 ,

 
   

2016

   

2015

 

Risk-free interest rate

    1.87

%

  2.06 - 2.93%

 

Expected volatility

    89.1

%

  92.9 - 93.0%

 

Expected life (in years)

    10.00         10.00  

Expected forfeiture rate

    10

%

      5%

 

Expected dividend yield

    0.0

%

      0.0%

 

 

Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price. The risk free interest rate is derived from values assigned to U.S. Treasury bonds with terms that approximate the expected option lives in effect at the time of grant. The model incorporates exercise, pre-vesting and post-vesting forfeiture assumptions based on analysis of historical data. The expiration of each option granted in fiscal 2016 and 2015 was used as the expected life.

 

Total compensation cost related to employee stock options and restricted stock awards totaled $283,186 and $462,468 for the three months ended June 30, 2016 and 2015, respectively.  Total compensation cost related to employee stock options and restricted stock awards totaled $898,520 and $1,310,081 for the six months ended June 30, 2016 and 2015, respectively.  No compensation cost related to share-based payment arrangements was capitalized as part of the cost of any asset as of June 30, 2016 and 2015.

 

As of June 30, 2016, there was $0.7 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements. That cost is expected to be recognized over a weighted-average period of 1.5 years. The weighted average grant-date fair value was $1.14 and $2.15 per share for the options granted during the six months ended June 30, 2016 and 2015, respectively.  The weighted average grant-date fair value was $1.63 and $3.47 for the restricted stock awards granted during the six months ended June 30, 2016 and 2015, respectively.  

 

Collectively, for all of the Company’s stock option plans there were a total of 801,376 equity awards available for future issuance as of June 30, 2016. 

   

 

Note 13.   Earn-out Milestone Liability

 

The total aggregate purchase price for the EGEN Acquisition included potential future Earn-out Payments contingent upon achievement of certain milestones. The difference between the aggregate $30.4 million in future Earn-out Payments and the $13.9 million included in the fair value of the acquisition consideration at June 20, 2014 was based on the Company's risk-adjusted assessment of each milestone (10% to 67%) and utilizing a discount rate based on the estimated time to achieve the milestone (1.5 to 2.5 years). The earn-out milestone liability will be fair valued at the end of each quarter and any change in their value will be recognized in the financial statements.

 

As of June 30, 2016, March 31, 2016 and December 31, 2015, the Company fair valued these milestones at $13.8 million, $14.2 million and $13.9 million, respectively, and recognized a non-cash benefit of $408,684 and $106,028 during the three and six month periods ended June 30, 2016, respectively, as a result of the change in the fair value of these milestones from the beginning of each period respectively. As of June 30, 2015, March 31, 2015 and December 31, 2014, the Company fair valued these milestones at $13.9 million, $13.8 million and $13.7 million, respectively, and recognized a non-cash charge of $69,392 and $241,528 during the three and six month periods ended June 30, 2015, respectively, as a result of the change in the fair value of these milestones from the beginning of each period respectively.

 

The following is a summary of the changes in the earn-out milestone liability for 2016:

 

Balance at January 1, 2016

  $ 13,921,412  

Non-cash charge from the adjustment for the change in fair value included in net loss

    (106,028

)

Balance at June 30, 2016

  $ 13,815,384  

   

 

 
16

 

     

The following is a schedule of the Company’s risk-adjustment assessment of each milestone:

 

Date

 

Risk-adjustment Assessment

of each Milestone

   

Discount Rate

   

Estimated Time

to Achieve (years)

 
                             

June 30, 2016

  10% to 75%       9 %   0.50  to 2.00  

March 31, 2016

  10% to 75%       9 %   0.25  to 2.25  

December 31, 2015

  10% to 75%       9 %   0.50  to 2.50  

June 30, 2015

  10% to 75%       9 %   0.92 to 3.00  

March 31, 2015

  10% to 67%       9 %   1.17  to 6.26  

December 31, 2014

  10% to 75%       9 %   1.25 to 6.50  

 

Note 14. Warrants

 

Common Stock Warrants

 

Following is a summary of all warrant activity for the six months ended June 30, 2016: 

 

Warrants

 

Number of

Warrants

Issued

   

Weighted

Average

Exercise Price

 
                 

Warrants outstanding at December 31, 2015

    5,894,675     $ 6.37  

Warrants issued during the six months ended June 30, 2016 (see Note 11)

    10,923,528       1.13  

Warrants expired during the six months ended June 30, 2016

             
                 

Warrants outstanding at June 30, 2016

    16,818,203     $ 2.97  
                 

Aggregate intrinsic value of outstanding warrants at June 30, 2016

  $ 2,646,000          
                 

Weighted average remaining contractual terms at June 30, 2016 (in years)

    2.86 (1)        

 

(1)

Does not include the Pre-Funded Warrants issued in the June 2016 Offering as these warrants have no expiration date.

   

 

Note 15.  Contingent Liabilities and Commitments

 

In July 2011, the Company executed a lease (the “Lease”) with Brandywine Operating Partnership, L.P. (Brandywine), a Delaware limited partnership for a 10,870 square foot premises located in Lawrenceville, New Jersey.  In October 2011, the Company relocated its offices to Lawrenceville, New Jersey from Columbia, Maryland.  The lease has a term of 66 months and provides for 6 months of rent free, with the first monthly rent payment of approximately $23,000 due and paid in April 2012.  Also, as required by the Lease, the Company provided Brandywine with an irrevocable and unconditional standby letter of credit for $250,000, which the Company secured with an escrow deposit at its banking institution of this same amount.  The standby letter of credit will be reduced by $50,000 on each of the 19th, 31st and 43rd months from the initial term, with the remaining $100,000 amount remaining until the Lease Term has expired. In connection with three $50,000 reductions of the standby letter of credit in April 2013 and 2014 and 2015, the Company reduced the escrow deposit by $50,000 each time. This lease has a remaining term of 10 months with rent payments of approximately $24,900 per month.

 

In connection with the EGEN Asset Purchase agreement in June 2014, the Company assumed the existing lease with another landlord for an 11,500 square foot premises located in Huntsville Alabama. This lease has a remaining term of 19 months with rent payments of approximately $23,200 per month.

 

   

Note 16.  Technology Development and Licensing Agreements

 

On May 7, 2012 the Company entered into a long term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun) for the production of ThermoDox® in the China territory.  In accordance with the terms of the agreement, Hisun will be responsible for providing all of the technical and regulatory support services, including the costs of all technical transfer, registration and bioequivalence studies, technical transfer costs, Celsion consultative support costs and the purchase of any necessary equipment and additional facility costs necessary to support capacity requirements for the manufacture of ThermoDox®.  Celsion will repay Hisun for the aggregate amount of these development costs and fees commencing on the successful completion of three registration batches of ThermoDox®.  Hisun is also obligated to certain performance requirements under the agreement.  The agreement will initially be limited to a percentage of the production requirements of ThermoDox® in the China territory with Hisun retaining an option for additional global supply after local regulatory approval in the China territory.  In addition, Hisun will collaborate with Celsion around the regulatory approval activities for ThermoDox® with the China State Food and Drug Administration (CHINA FDA).  During the first quarter of 2015, Hisun completed the successful manufacture of three registration batches of ThermoDox® and the Company accrued $685,787 for the aggregate development costs and fees associated with these batches in March 2015. This amount was paid in April 2015.

 

 

 
17

 

 

On January 18, 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable research and development fee of $5 million to support our development of ThermoDox ® in mainland China, Hong Kong and Macau (the China territory).  Following our announcement on January 31, 2013 that the HEAT Study failed to meet its primary endpoint, Celsion and Hisun have agreed that the Technology Development Contract entered into on January 18, 2013 will remain in effect while the parties continue to collaborate and are evaluating the next steps in relation to ThermoDox®, which include the sub-group analysis of patients in the Phase III HEAT Study for the hepatocellular carcinoma clinical indication and other activities to further the development of ThermoDox ® for the Greater China market.  The $5.0 million received as a non-refundable payment from Hisun in the first quarter 2013 has been recorded to deferred revenue and will continue to be amortized over the 10 year term of the agreement, until such time as the parties find a mutually acceptable path forward on the development of ThermoDox ® based on findings of the ongoing post-study analysis of the HEAT Study data.

 

On July 19, 2013, the Company and Hisun entered into a Memorandum of Understanding to pursue ongoing collaborations for the continued clinical development of ThermoDox® as well as the technology transfer relating to the commercial manufacture of ThermoDox® for the China territory. This expanded collaboration includes development of the next generation liposomal formulation with the goal of creating safer, more efficacious versions of marketed cancer chemotherapeutics.

  

Among the key provisions of the Celsion-Hisun Memorandum of Understanding are:

  

Hisun will provide the Company with non-dilutive financing and the investment necessary to complete the technology transfer of its proprietary manufacturing process and the production of registration batches for the China territory;

Hisun will collaborate with the Company around the clinical and regulatory approval activities for ThermoDox® as well as other liposomal formations with the CHINA FDA; and

Hisun will be granted a right of first offer for a commercial license to ThermoDox® for the sale and distribution of ThermoDox® in the China territory.

   

On August 9, 2016, we signed a long-term Technology Transfer, Manufacturing and Commercial Supply Agreement (the GEN-1 Agreement) with Hisun to pursue an expanded partnership for the technology transfer relating to the clinical and commercial manufacture and supply of GEN-1, Celsion’s proprietary gene mediated, IL-12 immunotherapy, for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. The GEN-1 Agreement will help to support supply for both ongoing and planned clinical studies in the United States, and for potential future studies of GEN-1 in China. GEN-1 is currently being evaluated by Celsion in first line ovarian cancer patients.

 

Key provisions of the GEN-1 Agreement are as follows:

   

the GEN-1 Agreement has targeted unit costs for clinical supplies of GEN-1 that are substantially competitive with the Company’s current suppliers;

once approved, the cost structure for GEN-1 will support rapid market adoption and significant gross margins across global markets;

Celsion will provide Hisun a certain percentage of China’s commercial unit demand, and separately of global commercial unit demand, subject to regulatory approval;

Hisun and Celsion will commence technology transfer activities relating to the manufacture of GEN-1, including all studies required by CFDA for site approval; and

Hisun will collaborate with Celsion around the regulatory approval activities for GEN-1 with the CFDA. A local China partner affords Celsion access to accelerated CFDA review and potential regulatory exclusivity for the approved indication.

 

 

 
18

 

 

Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

Forward-Looking Statements

 

Statements and terms such as “expect”, “anticipate”, “estimate”, “plan”, “believe” and words of similar import regarding our expectations as to the development and effectiveness of our technologies, the potential demand for our products, and other aspects of our present and future business operations, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although we believe that our expectations are based on reasonable assumptions within the bounds of our knowledge of our industry, business and operations, we cannot guarantee that actual results will not differ materially from our expectations. In evaluating such forward-looking statements, readers should specifically consider the various factors contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed on March 30 , 2016 with the Securities and Exchange Commission, which factors include, without limitation, plans and objectives of management for future operations or programs or proposed new products or services; changes in the course of research and development activities and in clinical trials; possible changes in cost and timing of development and testing; possible changes in capital structure, financial condition, working capital needs and other financial items; changes in approaches to medical treatment; clinical trial analysis and future plans relating thereto; our ability to realize the full extent of the anticipated benefits of our acquisition of substantially all of the assets of EGEN, Inc., including achieving operational cost savings and synergies in light of any delays we may encounter in the integration process and additional unforeseen expenses; introduction of new products by others; possible licenses or acquisitions of other technologies, assets or businesses; and possible actions by customers, suppliers, partners, competitors and regulatory authorities. These and other risks and uncertainties could cause actual results to differ materially from those indicated by forward-looking statements.

 

The discussion of risks and uncertainties set forth in this Quarterly Report on Form 10-Q and in our most recent Annual Report on Form 10-K, as well as in other filings with the SEC, is not a complete or exhaustive list of all risks facing the Company at any particular point in time. We operate in a highly competitive, highly regulated and rapidly changing environment and our business is constantly evolving. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not possible for management to predict all such risk factors or changes therein, or to assess either the impact of all such risk factors on our business or the extent to which any individual risk factor, combination of factors, or new or altered factors, may cause results to differ materially from those contained in any forward-looking statement. We disclaim any obligation to revise or update any forward-looking statement that may be made from time to time by us or on our behalf.

 

Strategic and Clinical Overview

 

Celsion is a fully-integrated oncology drug development stage company focused on advancing, through rigorous trials, a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy and RNA based therapies. Our lead product candidate is ThermoDox ® , a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in a Phase III clinical trial for the treatment of primary liver cancer (the OPTIMA Study) and a Phase II clinical trial for the treatment of recurrent chest wall breast cancer (the DIGNITY Study). Second in our pipeline is GEN-1 (formerly known as EGEN-001), a DNA-mediated immunotherapy for the localized treatment of ovarian and brain cancers. We have three platform technologies providing the basis for the future development of a range of therapeutics for difficult-to-treat forms of cancer including: Lysolipid Thermally Sensitive Liposomes, a heat sensitive liposomal based dosage form that targets disease with known therapeutics in the presence of mild heat, TheraPlas, a novel nucleic acid-based treatment for local transfection of therapeutic plasmids, and TheraSilence, a systemic dosage form for lung directed anti-cancer RNA. With these technologies we are working to develop and commercialize more efficient, effective and targeted oncology therapies that maximize efficacy while minimizing side-effects common to cancer treatments.

 

ThermoDox®

 

ThermoDox ® is being evaluated in a Phase III clinical trial for primary liver cancer (the OPTIMA Study) which was initiated in 2014 and a Phase II clinical trial for recurrent chest wall breast cancer (the DIGNITY Study). ThermoDox ® is a liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers.  Localized heat at hyperthermia temperatures (greater than 40° Celsius) releases the encapsulated doxorubicin from the liposome enabling high concentrations of doxorubicin to be deposited preferentially in and around the targeted tumor.

 

The HEAT Study. On January 31, 2013, we announced that ThermoDox ® in combination with radio frequency ablation (RFA) did not meet the primary endpoint of progression free survival for the 701 patient clinical trial in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer (the HEAT Study). We determined, after conferring with the HEAT Study’s independent Data Monitoring Committee (iDMC), that the HEAT Study did not meet the goal of demonstrating persuasive evidence of clinical effectiveness, that being a clinically meaningful improvement in progression free survival (PFS), that could form the basis for regulatory approval. In the trial, ThermoDox ® was well-tolerated with no unexpected serious adverse events. Following the announcement of the HEAT Study results, we followed patients for overall survival (OS), the secondary endpoint of the HEAT Study. We have conducted a comprehensive analysis of the data from the HEAT Study to assess the future strategic value and development strategy for ThermoDox ® .

 

Findings from the HEAT Study post-hoc data analysis suggest that ThermoDox ® may substantially improve OS, when compared to the control group, in patients if their lesions undergo a 45 minute RFA procedure standardized for a lesion greater than 3 cm in diameter. Data from nine OS sweeps have been conducted since the top line PFS data from the HEAT Study were announced in January 2013, with each data set showing progressive improvement in statistical significance. On August 15, 2016, the Company announced updated results from its final retrospective OS analysis of the data from the HEAT Study. These results demonstrated that in a large, well bounded, subgroup of patients (n= 285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an average 54% risk improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02. Median overall survival for the ThermoDox® group has been reached which translates into a two year survival benefit over the optimized RFA group (projected to be greater than 80 months for the ThermoDox® plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group).  

 

 
19

 

 

Additional findings from this most recent analysis specific to the Chinese patient cohort of 223 patients are summarized below:

 

 

In the population of 154 patients with single lesions (70% of the HEAT Study Chinese patient cohort) who received optimized RFA treatment for 45 minutes or more showed a 53% risk improvement in OS (HR = 0.66) when treated with ThermoDox® plus optimized RFA.

     

 

These data continue to support and further strengthen ThermoDox®'s potential to significantly improve OS compared to an RFA control in patients with lesions that undergo optimized RFA treatment for 45 minutes or more. The clinical benefit seen in the ITT Chinese patient cohort further confirms the importance of RFA heating time as 72% of patients in this large patient cohort in China received an optimized RFA treatment.

 

Findings from the HEAT Study post-hoc data analysis have shown to be well balanced and not diminished in anyway by other factors. Supplementary computational modeling and prospective preclinical animal studies have shown additional support the relationship between heating duration and clinical outcomes. These data have been presented, without objection, at multiple scientific and medical conferences in 2013 through 2016 by key HEAT Study investigators and leading liver cancer experts. The presentations include:

 

 

World Conference on Interventional Oncology in May 2013;

     

 

European Conference on Interventional Oncology in June 2013 and April 2014;

     

  

International Liver Cancer Association Annual Conference in September 2013, 2014 and 2015;

     

  

American Society of Clinical Oncology 50 th Annual Meeting in June 2014; and

     

 

Asian Conference on Tumor Ablation in October 2015 and July 2016.

The OPTIMA Study. On February 24, 2014, we announced that the U.S. Food and Drug Administration (FDA), after its customary 30 day review period, accepted our IND without comment, subject to compliance with regulatory standards, for our pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox ® , our proprietary heat-activated liposomal encapsulation of doxorubicin in combination with RFA in primary liver cancer, also known as HCC (the OPTIMA Study). The OPTIMA Study trial design is based on the comprehensive analysis of data from the HEAT Study, which, as described previously, demonstrated that treatment with ThermoDox ® resulted in a 58% improvement in OS in a large number of HCC patients that received an optimized RFA treatment for longer than 45 minutes. Designed with extensive input from globally recognized HCC researchers and clinicians and, after formal written consultation with the FDA, the OPTIMA Study was launched in the first half of 2014. The OPTIMA Study is expected to enroll up to 550 patients globally at up to 75 sites in the United States, Canada, Europe, China and elsewhere in the Asia Pacific region, and will evaluate ThermoDox ® in combination with standardized RFA, which will require a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The primary endpoint for the trial is OS, and the secondary endpoints for the trial are PFS and safety. The statistical plan calls for two interim efficacy analyses by an independent DMC.

 

On December 16, 2015, we announced that we had received the clinical trial application approval from the CFDA to conduct the OPTIMA Study in China. This clinical trial application approval will now allow Celsion to enroll patients at up to 2 0 additional clinical sites in China. With the addition of these Chinese clinical sites, the Company expects to complete enrollment in the OPTIMA Study during the first quarter of 2018. On April 26, 2016, we announced that the first patient in China has been enrolled in the OPTIMA Study. Results from the OPTIMA Study, if successful, will provide the basis for a global registration filing and marketing approval.

 

The DIGNITY Study. On December 14, 2015, we announced final data from the Phase I/II study of ThermoDox® in recurrent chest wall (RCW) breast cancer (the DIGNITY Study) at the San Antonio Breast Cancer Symposium. The DIGNITY Study is designed to establish a safe therapeutic dose in Phase I, and in Phase II to demonstrate local control, including complete and partial responses, and stable disease as its primary endpoint.  The DIGNITY Study is also planned to evaluate kinetics in ThermoDox® produced from more than one manufacturing site. Of the 28 patients enrolled and treated, 21 patients were eligible for evaluation of efficacy. Approximately 62% of evaluable patients experienced a local response, including six complete responses and seven partial responses.

 

These data are consistent with the combined clinical data from two Phase I trials, our Phase I DIGNITY Study and the Duke University sponsored Phase I trial of ThermoDox® plus hyperthermia in RCW breast cancer in December 2013. The two similarly designed Phase I studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapy including chemotherapy, radiation therapy and hormone therapy. There were 29 patients treated in the two trials, including 11 patients in the DIGNITY Study and 18 patients in the Duke study. Of the 29 patients treated, 23 were eligible for evaluation of efficacy. A local response rate of over 60 percent was reported in 14 of the 23 evaluable patients with five complete responses and nine partial responses.

  

 

 
20

 

 

The Euro-DIGNITY Study. The Company anticipates that a Phase II study of Radiation Therapy, Hyperthermia and ThermoDox® to treat patients with local-regional recurrent chest wall breast cancer will be initiated by five clinical sites located in Italy, Israel, Poland and the Czech Republic (the Euro-DIGNITY Study). The Euro-DIGNITY Study will be Phase II study enrolling up to 70 patients affected by recurrent breast adenocarcinoma on the chest wall with/without nodes over a period of two years.  

 

The primary objectives of the Euro-DIGNITY Study will be (i) to evaluate efficacy in patients after treatment with ThermoDox® plus Hyperthermia measuring tumor diameter as a response to therapy and (ii) to evaluate loco-regional breast tumor control in patients who undergo ThermoDox ® /hyperthermia/radiation therapy as measured by target lesion clinical response rate combining a RECIST criteria with digital photography to gauge response.

 

Secondary objectives of the Euro-DIGNITY Study will be (i) to evaluate the safety of the combination of ThermoDox®/ Hyperthermia/Radiation Therapy among patients with local-regional recurrence (LRR) breast cancer, (ii) to evaluate the duration of local control complete response, partial response and stable disease following treatment with ThermoDox/ Hyperthermia/ Radiation Therapy up to 24 months among patients with LRR breast cancer and (iii) to assess Patient Reported Quality of Life using the FACT-B and Brief Pain Inventory following treatment with ThermoDox/Hyperthermia/ Radiation Therapy among patients with LRR breast cancer.

 

Early Access Program for ThermoDox for the Treatment of Patients with RCW Breast Cancer. On January 13, 2015, we entered into an Early Access Agreement with Impatients N.V., a Netherlands company (Impatients), pursuant to which Impatients will develop and execute through its brand myTomorrows an early access program for ThermoDox ® in all countries of the European Union territory, Iceland, Liechtenstein, Norway and Switzerland for the treatment of patients with RCW breast cancer. Under the early access program, Impatients will engage in activities to secure authorization, exemption or waiver from regulatory authorities for patient use of ThermoDox ® that may otherwise be subject to approvals from such regulatory authorities before the sale and distribution of ThermoDox ® in the relevant territories. We will be responsible for the manufacture and supply of quantities of ThermoDox ® to Impatients for use in the Early Access Program and Impatients will distribute and sell ThermoDox ® pursuant to such authorization, exemptions or waivers. On August 10, 2015, we expanded the Early Access Program with myTomorrows to include patients with primary liver cancer, also known as hepatocellular carcinoma, and liver cancer metastases, in all of the European Union territory, Switzerland, Turkey and Israel.

 

In consideration for Impatients’ services to implement the early access program and in the event we receive regulatory authorization to sell, distribute or market ThermoDox® in the Territory, we will be obligated to pay Impatients, subject to a maximum cap, a low single-digit royalty of net sales of ThermoDox® in the countries where such regulatory authorization has been obtained. The Early Access Agreement has a term of five years, with automatic renewals for consecutive two-year periods, unless earlier terminated by either party with notice or in the event of material breach, bankruptcy, or insolvency without notice.

 

Acquisition of EGEN

 

On June 20, 2014, we completed the acquisition of substantially all of the assets of EGEN, Inc., an Alabama corporation (EGEN), pursuant to an Asset Purchase Agreement. We acquired all of EGEN’s right, title and interest in and to substantially all of the assets of EGEN, including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits, equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. In addition, CLSN Laboratories assumed certain specified liabilities of EGEN, including the liabilities arising out of the acquired contracts and other assets relating to periods after the closing date. The consideration of the acquisition includes an initial payment of approximately $3.0 million in cash plus 2.7 million shares of Celsion’s common stock. Additional consideration included contingent value rights totaling $30.4 million, payable in cash, shares of Celsion common stock or a combination thereof, at Celsion’s option, upon achievement of three major milestone events as follows:

 

 

a)

$12.4 million will become payable upon achieving certain specified development milestones relating to an ovarian cancer study of GEN-1 to be conducted by the Company or its subsidiary;

  

b)

$12.0 million will become payable upon achieving certain specified development milestones relating to a glioblastoma multiforme brain cancer study of GEN-1 to be conducted by the Company or its subsidiary; and

  

c)

Up to $6.0 million will become payable upon achieving certain specified milestones relating to the TheraSilence™ technology.

  

 

 
21

 

 

Our obligations to make the Earn-Out Payments will terminate on the seventh anniversary of the closing date.

 

The acquisition of EGEN was accounted for under the acquisition method of accounting which required the Company to perform an allocation of the purchase price to the assets acquired and liabilities assumed. The fair value of the consideration transferred for the acquisition is approximately $27.6 million.  

 

Under the acquisition method of accounting, the total purchase price is allocated to EGEN’s net tangible and intangible assets and liabilities based on their estimated fair values as of the acquisition date. The table below summarizes the preliminary estimated fair values of EGEN’s net tangible and intangible assets and liabilities on the acquisition date.                         

 

Property and equipment, net

  $ 35,000  

In-process research and development

    25,802,000  

Goodwill

    1,976,000  

Total assets:

    27,813,000  

Accounts payable and accrued liabilities

    (235,000

)

Net assets acquired

  $ 27,578,000  

 

With the acquisition, we obtained GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers, and three platform technologies for the development of treatments for those suffering with difficult-to-treat forms of cancer, novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas™ and TheraSilence™. Acquired In-Process Research and Development (IPR&D) consists of EGEN's drug technology platforms: GEN-1, TheraPlas™ and TheraSilence™. The fair value of the IPR&D drug technology platforms was estimated to be $25.8 million as of the acquisition date. As of the closing of the acquisition, the IPR&D is considered indefinite lived intangible assets and will not be amortized. IPR&D will be reviewed for possible impairment on an annual basis or more frequently if there appears to be an indication of impairment. The purchase price exceeds the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as goodwill.

 

GEN-1: The OVATION Study. In February 2015, we announced that the FDA accepted, without objection, the Phase I dose-escalation clinical trial of GEN-1 in combination with the standard of care in neo-adjuvant ovarian cancer (the OVATION Study). On September 30, 2015, we announced enrollment of the first patient in the OVATION Study. The OVATION Study will seek to identify a safe, tolerable and potentially therapeutically active dose of GEN-1 by recruiting and maximizing an immune response and is designed to enroll three to six patients per dose level and will evaluate safety and efficacy and attempt to define an optimal dose for a follow-on Phase I/II study combining GEN-1 with Avastin® and Doxil®.   In addition, the OVATION Study establishes a unique opportunity to assess how cytokine-based compounds such as GEN-1, directly affect ovarian cancer cells and the tumor microenvironment in newly diagnosed patients. The study is designed to characterize the nature of the immune response triggered by GEN-1 at various levels of the patients' immune system, including:

 

infiltration of cancer fighting T-cell lymphocytes into primary tumor and tumor microenvironment including peritoneal cavity, which is the primary site of metastasis of ovarian cancer;

changes in local and systemic levels of immuno-stimulatory and immunosuppressive cytokines associated with tumor suppression and growth, respectively; and  

expression profile of a comprehensive panel of immune related genes in pre-treatment and GEN-1-treated tumor tissue.  

 

We have initiated the study at four clinical sites at the University of Alabama at Birmingham, Oklahoma University Medical Center, Washington University in St. Louis and the Medical College of Wisconsin. In February 2016, we announced the completion of enrollment of the first cohort of patients in the OVATION Study. The OVATION Study will continue into 2016 at higher doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response.

 

 

 
22

 

 

On May 2, 2016 and July 25, 2016, we announced data from the first and second cohorts of patients in the OVATION Study, respectively. The OVATION Study is designed to enroll three to six patients per dose cohort and will continue into 2016 at higher doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first two cohorts each enrolled three patients.  Enrollment in the third cohort is ongoing, and Celsion expects to complete the OVATION Study this year. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil®. The results of the OVATION Study to date are as follows:

 

Of the first six patients dosed, one patient demonstrated a complete response (CR), two patients demonstrated a partial response (PR) and three patients demonstrated stable disease (SD), as measured by RECIST criteria.

Five patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed and three patients with a R1 resection, indicating microscopic residual tumor. One patient in the second cohort is currently ineligible for debulking surgery due to a medical complication unrelated to the study or the study drug.

Of the five surgically treated and evaluable patients, one patient (20%) demonstrated a pathological complete response (pCR), two patients (40%) demonstrated a micro pathological response (microPR), and two patients (40%) demonstrated a macroPR. These data compare favorably to historical data, which indicate that pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection. pCRs have been associated with a median overall survival of 72 months, which is more than three years longer than those who do not experience a pCR. In addition, microPRs are seen in approximately 30% of patients, and are associated with a median overall survival of 38 months.

 

GEN-1 Plus Doxil ® and Avastin ® Trial. On April 29, 2015, we announced the expansion of our ovarian cancer development program to include a Phase I dose escalating trial to evaluate GEN-1 in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer patients. We expect to enroll patients beginning in the second half of 2016. This new combination study in platinum-resistant ovarian cancer is supported by three preclinical studies indicating that the combination of GEN-1 with Avastin® may result in significant clinical benefit with a favorable safety profile. Specifically:

 

In two preclinical studies using an animal model of disseminated ovarian cancer, GEN-1 in combination with Avastin® led to a significant reduction in tumor burden and disease progression.  The effectiveness of the combined treatment was seen when GEN-1 was combined with various dose levels of Avastin® (low-medium-high).  Additionally, it was shown that GEN-1 treatment alone resulted in anti-tumor activity that was as good as or better than Avastin® treatment alone.

The preclinical studies indicated that no obvious overt toxicities were associated with the combined treatments.  The preclinical data are also consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties and suggests that combining GEN-1 with lower doses of Avastin® may enhance efficacy and help reduce the known toxicities associated with this anti-VEGF drug.

The distinct biological activities of GEN-1 (immune stimulation) and Avastin® (inhibition of tumor blood vessel formation) makes a sound scientific rationale for this combination approach.  Additionally, the anti-angiogenic activity of GEN-1 mediated through up regulation of the interferon gamma (IFN-g) pathway may help to explain the remarkable synergy between GEN-1 and Avastin® and potentially addresses the VEGF escape mechanisms associated with resistance to Avastin® therapy.

 

Technology Development and Licensing Agreements

 

On August 9, 2016, we signed a long-term Technology Transfer, Manufacturing and Commercial Supply Agreement (the GEN-1 Agreement) with Hisun to pursue an expanded partnership for the technology transfer relating to the clinical and commercial manufacture and supply of GEN-1, Celsion’s proprietary gene mediated, IL-12 immunotherapy, for the greater China territory, with the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. The GEN-1 Agreement will help to support supply for both ongoing and planned clinical studies in the United States, and for potential future studies of GEN-1 in China. GEN-1 is currently being evaluated by Celsion in first line ovarian cancer patients.

 

Key provisions of the GEN-1 Agreement are as follows:

   

the GEN-1 Agreement has targeted unit costs for clinical supplies of GEN-1 that are substantially competitive with the Company’s current suppliers;

once approved, the cost structure for GEN-1 will support rapid market adoption and significant gross margins across global markets;

Celsion will provide Hisun a certain percentage of China’s commercial unit demand, and separately of global commercial unit demand, subject to regulatory approval;

Hisun and Celsion will commence technology transfer activities relating to the manufacture of GEN-1, including all studies required by CFDA for site approval; and

Hisun will collaborate with Celsion around the regulatory approval activities for GEN-1 with the CFDA. A local China partner affords Celsion access to accelerated CFDA review and potential regulatory exclusivity for the approved indication.

 

 

 
23

 

 

In June 2012, Celsion and Hisun signed a long-term commercial supply agreement for the production of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin. Hisun is one the largest manufacturers of chemotherapy agents globally, including doxorubicin.  In July 2013, the ThermoDox® collaboration was expanded to focus on next generation liposomal formulation development with the goal of creating safer, more efficacious versions of marketed cancer chemotherapeutics. During 2015, Hisun successfully completed the manufacture of three registration batches for ThermoDox® and has obtained regulatory approvals to supply ThermoDox® to participating clinical trial sites in all of the countries of South East Asia, Europe and North America, as well as to the European Union countries allowing for early access to ThermoDox®. The future manufacturing of clinical and commercial supplies by Hisun will result in a cost structure allowing Celsion to profitably access all global markets, including third world countries, and help accelerate the Company’s product development program in China for ThermoDox® in primary liver cancer and other indications.

 

Financing Overview

 

Equity and Debt Financings

 

During 2014 and 2015 and thus far in 2016, we issued a total of 9.2 million shares of common stock; in the following equity transactions for an aggregate $29.6 million in gross proceeds.

 

On June 16, 2016, we entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in a registered offering, an aggregate of 2,311,764 shares of its common stock and warrants to purchase up to 10,923,528 shares of common stock, for an aggregate purchase price of approximately $6.0 million.

On May 27, 2015, the Company entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in a registered direct offering, an aggregate of 3,000,000 shares of common stock, for an aggregate purchase price of approximately $8.0 million. In a concurrent private placement, the Company issued to the same investors warrants to purchase up to 1,950,000 shares of common stock.

On January 15, 2014, we entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in a registered offering, an aggregate of 3,603,604 shares of its common stock and warrants to purchase up to 1,801,802 shares of common stock, for an aggregate purchase price of approximately $15 million.

We are a party to a Controlled Equity Offering SM Sales Agreement (ATM) dated as of February 1, 2013 with Cantor Fitzgerald & Co., pursuant to which we may sell additional shares of our common stock having an aggregate offering price of up to $25 million through “at-the-market” equity offerings from time to time. From February 1, 2013 through February 25, 2013, the Company sold and issued an aggregate of 1,195,927 shares of common stock under the ATM, receiving approximately $6.8 million in net proceeds. The Company did not have any sales under the ATM from February 25, 2013 through September 30, 2015. On October 2, 2015, the Company filed a prospectus supplement whereby it registered $7.5 million of the remaining availability under the ATM. During the fourth quarter of 2015, the Company sold an aggregate of 283,608 shares for gross proceeds of $0.6 million.

 

On June 20, 2014, we completed the acquisition of substantially all of the assets of EGEN, Inc. At the closing, we paid approximately $3.0 million in cash and issued 2,712,188 shares of its common stock to EGEN. In addition, 670,070 shares of common stock are issuable to EGEN on or after August 2, 2016 pending satisfactory resolution of any post-closing adjustments of expenses and EGEN’s indemnification obligations under the EGEN Purchase Agreement

 

In addition, we entered into a loan agreement on November 25, 2013 with Hercules Technology Growth Capital, Inc. (Hercules), pursuant to which we may borrow a secured term loan of up to $20 million in multiple tranches (the Hercules Credit Agreement). The loan bears interest at a floating per annum rate equal to the greater of (i) 11.25 percent and (ii) the sum of 11.25 percent plus the prime rate minus 3.25 percent. Payments under the loan agreement are interest only for the first twelve months after loan closing, followed by a 30-month amortization period of principal and interest through the scheduled maturity date. We drew the first tranche of $5 million on November 25, 2013 and may request, subject to Hercules’ consent in its sole discretion, an additional $15 million in up to three advances with each advance in a minimum amount of $5 million before June 30, 2014 unless extended upon Hercules’ consent. We used approximately $4 million of the first tranche to repay the outstanding obligations under a loan agreement with Oxford Finance LLC and Horizon Technology Finance Corporation. On June 9, 2014, we borrowed an additional $5 million and used the loan proceeds to pay the upfront cash payment to EGEN at closing and certain transaction costs incurred in connection with the acquisition.

 

 

 
24

 

 

We believe that our cash and cash equivalents and short-term investments of $14.5 million on hand at June 30, 2016, coupled with our access to the ATM, are sufficient to fund operations into the second quarter of 2017.  However, our future capital requirements will depend upon numerous unpredictable factors, including, without limitation, the cost, timing, progress and outcomes of clinical studies and regulatory reviews of our proprietary drug candidates, our efforts to implement new collaborations, licenses and strategic transactions, general and administrative expenses, capital expenditures and other unforeseen uses of cash. To complete the development and commercialization of our products, we will need to raise substantial amounts of additional capital to fund our operations. We do not have any committed sources of financing and cannot give assurance that alternate funding will be available in a timely manner, on acceptable terms or at all. We may need to pursue dilutive equity financings, such as the issuance of shares of common stock, preferred stock, convertible debt or other convertible or exercisable securities, which financings could dilute the percentage ownership of our current common stockholders and could significantly lower the market value of our common stock.

 

Please refer to Item IA, Risk Factors, including, but not limited to, “ We will need to raise substantial additional capital to fund our planned future operations, and we may be unable to secure such capital without dilutive financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testing and commercialization of our product candidates .

 

As a clinical stage biopharmaceutical company, our business and our ability to execute our strategy to achieve our corporate goals are subject to numerous risks and uncertainties. Material risks and uncertainties relating to our business and our industry are described in "Item 1A. Risk Factors" under "Part II: Other Information" included herein.

 

FINANCIAL REVIEW FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2016 AND 2015

 

Results of Operations

 

For the three months ended June 30, 2016, our net loss was $4.5 million compared to a net loss of $5.7 million for the same period of 2015. For the six months ended June 30, 2016, our net loss was $10.2 million compared to a net loss of $12.7 million for the same period of 2015. As of June 30, 2016, we had $14.5 million in cash and short-term investments.

 

   

Three Months Ended June 30,

 
   

(In thousands)

   

Change

Increase (Decrease)

 
   

2016

   

2015

           

%

 
                                 

Licensing Revenue:

  $ 125     $ 125     $      

%

                                 

Operating Expenses:

                               

Clinical research

    3,192       3,078       114       3.7

%

Chemistry, manufacturing and controls

    145       490       (345

)

    (70.0

)%

Research and development

    3,337       3,568       (231

)

    (6.5

)%

General and administrative

    1,529       1,802       (273

)

    (15.1

)%

Total operating expenses

    4,866       5,370       (504

)

    (9.4

)%

                                 

Loss from operations

  $ (4,741

)

  $ (5,245

)

  $ 504       9.6

%

 

 

 
25

 

       

   

Six Months Ended June 30,

 
   

(In thousands)

   

Change

Increase (Decrease)

 
   

2016

   

2015

           

%

 
                                 

Licensing Revenue:

  $ 250     $ 250     $      

%

                                 

Operating Expenses:

                               

Clinical research

    6,000       6,377       (377

)

    (5.9

)%

Chemistry, manufacturing and controls

    777       1,697       (920

)

    (54.2

)%

Research and development

    6,777       8,074       (1,297

)

    (16.1

)%

General and administrative

    3,392       3,834       (442

)

    (11.5

)%

Total operating expenses

    10,169       11,908       (1,739

)

    (14.9

)%

                                 

Loss from operations

  $ (9,919

)

  $ (11,658

)

  $ 1,739       15.2

%

 

Comparison of the Three Months ended June 30, 2016 and 2015

 

Licensing Revenue

 

In January 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable technology transfer fee of $5.0 million to support our development of ThermoDox® in the China territory. The $5.0 million received as a non-refundable payment from Hisun in the first quarter 2013 has been recorded to deferred revenue and will be amortized over the ten year term of the agreement; therefore we recorded deferred revenue of $125,000 in each of the second quarters of 2016 and 2015.

  

Research and Development Expenses

 

Research and development (R&D) expenses decreased by $0.2 million to $3.3 million in the second quarter of 2016 from $3.6 million in the same period of 2015.  Costs associated with the OPTIMA Study were $1.5 million in the second quarter of 2016 compared to $0.7 million in the same period of 2015. Study costs associated with the HEAT Study were relatively insignificant in the second quarter of 2016 compared to $0.1 million in the same period of 2015. The costs associated with the HEAT Study are expected to be minimal as we continue to follow patients for overall survival only. Costs associated with our recurrent chest wall breast cancer clinical trial were relatively insignificant in each of the second quarters of 2016 and 2015. Other clinical costs were $0.8 million in the second quarter of 2016 compared to $0.6 million in the same period of 2015. The increase of other clinical costs is associated with costs to support the Company’s ThermoDox® studies in Europe. Other R&D costs were $0.1 million in the second quarter of 2016 compared to $0.3 million in the same period of 2015. Costs associated with the production of ThermoDox® to support the OPTIMA Study decreased to $0.1 million in the second quarter of 2016 compared to $0.5 million the same period of 2015. Costs associated with the R&D of GEN-1 was $0.8 million in the second quarter of 2016 compared to $1.3 million the same period of 2015. In 2015, the Company produced sufficient quantities of GEN-1 and related components to fulfil its GEN-1 clinical study requirements into 2017.

 

General and Administrative Expenses

 

General and administrative (G&A) expenses decreased by $0.3 million to $1.5 million in the second quarter of 2016 compared to $1.8 million the same period of 2015. This decrease is attributable to lower personnel related costs and profession fees in 2016. We continue to take those steps necessary to reduce our overhead expenses.

 

Change in Earn-out Milestone Liability

 

The total aggregate purchase price for the acquisition of assets from EGEN included potential future earn-out payments contingent upon achievement of certain milestones. The difference between the aggregate $30.4 million in future earn-out payments and the $13.9 million included in the fair value of the acquisition consideration at June 20, 2014 was based on the Company's risk-adjusted assessment of each milestone and utilizing a discount rate based on the estimated time to achieve the milestone. These milestone payments will be fair valued at the end of each quarter and any change in their value will be recognized in the financial statement. As of June 30, 2016, the Company fair valued these milestones at $13.8 million and recognized a non-cash gain of $0.4 million in the second quarter of 2016 as a result of the change in the fair value of these milestones from $14.2 million at March 31, 2016. The Company recognized a non-cash charge of $0.1 million in the second quarter of 2015 as a result of the change in the fair value of these milestones at $13.9 million at June 30, 2015 from $13.8 million at March 31, 2015.

 

 

 
26

 

 

Investment income and interest expense

 

In connection with its debt facilities the Company incurred $0.2 million and $0.4 million in interest expense in the three month periods ended June 30, 2016 and 2015, respectively.

 

Change in Warrant Liability and O ther (expense) income

 

Change in warrant liability and other (expense) income for the second quarters of 2016 and 2015 was not significant. 

 

Comparison of the Six Months ended June 30, 2016 and 2015

 

Licensing Revenue

 

In January 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable technology transfer fee of $5.0 million to support our development of ThermoDox® in the China territory. The $5.0 million received as a non-refundable payment from Hisun in the first quarter 2013 has been recorded to deferred revenue and will be amortized over the ten year term of the agreement; therefore we recorded deferred revenue of $250,000 in each of the first halves of 2016 and 2015.

  

Research and Development Expenses

 

R&D expenses decreased by $1.3 million to $6.8 million in the first half of 2016 from $8.1 million in the same period of 2015.  Costs associated with the OPTIMA Study were $2.4 million in the first half of 2016 compared to $1.8 million in the same period of 2015. Study costs associated with the HEAT Study were relatively insignificant in the first half of 2016 compared to $0.3 million in the same period of 2015. The costs associated with the HEAT Study are expected to be minimal as we continue to follow patients for overall survival only. Costs associated with our recurrent chest wall breast cancer clinical trial were relatively insignificant in each of the first half of 2016 and 2015. Other clinical costs were $1.7 million in the first half of 2016 compared to $1.0 million in the same period of 2015. The increase of other clinical costs is associated with costs to support the Company’s ThermoDox® studies in Europe. ThermoDox® preclinical and regulatory R&D costs were $0.1 million in the first half of 2016 compared to $0.7 million in the same period of 2015. The decrease of these costs is due to lower personnel related expenses and other preclinical activities. Costs associated with the production of ThermoDox® to support the OPTIMA Study decreased to $0.8 million in the first half of 2016 compared to $1.7 million the same period of 2015. Costs associated with the R&D of GEN-1 was $1.6 million in the first half of 2016 compared to $2.4 million the same period of 2015. In 2015, the Company produced sufficient quantities of GEN-1 and related components to fulfill its GEN-1 clinical study requirements into 2017.

 

General and Administrative Expenses

 

General and administrative (G&A) expenses decreased by $0.4 million to $3.4 million in the first half of 2016 compared to $3.8 million the same period of 2015. This decrease is attributable to lower personnel related costs and profession fees in 2016. We continue to take those steps necessary to reduce our overhead expenses.

 

Change in Earn-out Milestone Liability

 

The total aggregate purchase price for the acquisition of assets from EGEN included potential future earn-out payments contingent upon achievement of certain milestones. The difference between the aggregate $30.4 million in future earn-out payments and the $13.9 million included in the fair value of the acquisition consideration at June 20, 2014 was based on the Company's risk-adjusted assessment of each milestone and utilizing a discount rate based on the estimated time to achieve the milestone. These milestone payments will be fair valued at the end of each quarter and any change in their value will be recognized in the financial statements. As of June 30, 2016, the Company fair valued these milestones at $13.8 million and recognized a non-cash gain of $0.1 million in the first half of 2016 as a result of the change in the fair value of these milestones from $13.9 million at December 31, 2015. The Company recognized a non-cash charge of $0.2 million in the first half of 2015 as a result of the change in the fair value of these milestones at $13.9 million at June 30, 2015 from $13.7 million at December 31, 2014.

 

 

 
27

 

     

Investment income and interest expense

 

In connection with its debt facilities the Company incurred $0.4 million and $0.8 million in interest expense in the six month periods ended June 30, 2016 and 2015, respectively.

 

Change in Warrant Liability and O ther (expense) income

 

Change in warrant liability and other (expense) income for the first six months of 2016 and 2015 was not significant. 

 

Financial Condition, Liquidity and Capital Resources

 

Since inception we have incurred significant losses and negative cash flows from operations.  We have financed our operations primarily through the net proceeds from the sales of equity, credit facilities and amounts received under our product licensing agreement with Yakult and our technology development agreement with Hisun. The process of developing and commercializing ThermoDox®, GEN-1 and other product candidates and technologies requires significant research and development work and clinical trial studies, as well as significant manufacturing and process development efforts.  We expect these activities, together with our general and administrative expenses to result in significant operating losses for the foreseeable future.  Our expenses have significantly and regularly exceeded our revenue, and we had an accumulated deficit of $229 million at June 30, 2016.                          

 

At June 30, 2016, we had total current assets of $15.0 million (including cash and cash equivalents and short-term investments of $14.5 million) and current liabilities of $10.4 million, resulting in net working capital of $4.6 million.  At December 31, 2015 we had total current assets of $20.3 million (including cash, cash equivalents and short term investments and related interest receivable on short-term investments of $20.1 million) and current liabilities of $9.3 million, resulting in net working capital of $11.0 million.  

 

Net cash used in operating activities for the first six months of 2016 was $9.0 million.  Our 2016 net loss for the six month period ended June 30, 2016 included $0.9 million in non-cash stock-based compensation expense and $0.1 million in a non-cash gain based on the change in the earn-out milestone liability.  

 

The $9.0 million net cash used in operating activities was mostly funded from cash and short term investments.  At June 30, 2016, we had cash and short term investments of $14.5 million.   

 

Net cash provided by financing activities was $3.4 million during the six month period ended June 30, 2016 which resulted from net proceeds of $5.4 million from the sale of our common stock in the second quarter of 2016 partially offset by principal payments of $2.0 million on the Hercules Credit Agreement.

 

On June 16, 2016, we entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in a registered offering, an aggregate of 2,311,764 shares of its common stock and warrants to purchase up to 10,923,528 shares of common stock, for an aggregate purchase price of approximately $6.0 million.

 

In February 2013, we entered into a Controlled Equity Offering SM Sales Agreement (ATM) with Cantor Fitzgerald & Co., as sales agent (Cantor), pursuant to which we may offer and sell, from time to time, through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (the ATM Shares) pursuant to our previously filed and effective Registration Statement on Form S-3. Under the ATM Agreement, Cantor may sell ATM Shares by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The NASDAQ Capital Market, on any other existing trading market for the our common stock or to or through a market maker.  We will pay Cantor a commission of three percent of the aggregate gross proceeds from each sale of ATM Shares. We have sold and issued an aggregate of 1,479,535 shares under the ATM Agreement so far, receiving approximately $7.4 million in net proceeds.

 

We believe that our cash and short-term investment resources of $14.5 million on hand at June 30, 2016, coupled with the remaining availability of $17.4 million under the ATM, are sufficient to fund operations into the second quarter of 2017.  However, our future capital requirements will depend upon numerous unpredictable factors, including, without limitation, the cost, timing, progress and outcomes of clinical studies and regulatory reviews of our proprietary drug candidates, our efforts to implement new collaborations, licenses and strategic transactions, general and administrative expenses, capital expenditures and other unforeseen uses of cash.

  

We may seek additional capital through further public or private equity offerings, debt financing, additional strategic alliance and licensing arrangements, collaborative arrangements, or some combination of these financing alternatives. If we raise additional funds through the issuance of equity securities, the percentage ownership of our stockholders could be significantly diluted and the newly issued equity securities may have rights, preferences, or privileges senior to those of the holders of our common stock. If we raise funds through the issuance of debt securities, those securities may have rights, preferences, and privileges senior to those of our common stock.  If we seek strategic alliances, licenses, or other alternative arrangements, such as arrangements with collaborative partners or others, we may need to relinquish rights to certain of our existing or future technologies, product candidates, or products we would otherwise seek to develop or commercialize on our own, or to license the rights to our technologies, product candidates, or products on terms that are not favorable to us.   The overall status of the economic climate could also result in the terms of any equity offering, debt financing, or alliance, license, or other arrangement being even less favorable to us and our stockholders than if the overall economic climate were stronger.   We also will continue to look for government sponsored research collaborations and grants to help offset future anticipated losses from operations and, to a lesser extent, interest income.

 

 

 
28

 

 

If adequate funds are not available through either the capital markets, strategic alliances, or collaborators, we may be required to delay or, reduce the scope of, or terminate our research, development, clinical programs, manufacturing, or commercialization efforts, or effect additional changes to our facilities or personnel, or obtain funds through other arrangements that may require us to relinquish some of our assets or rights to certain of our existing or future technologies, product candidates, or products on terms not favorable to us.

 

Off-Balance Sheet Arrangements and Contractual Obligations

 

We have no off-balance sheet financing arrangements.  There were no material changes during the six months ended June 30, 2016 to our operating leases, which are disclosed in the contractual commitments table in our Annual Report on Form 10-K and on Form 10K/A for the fiscal year ended December 31, 2015 filed on March 30, 2016 and April 29, 2016, respectively, with the Securities and Exchange Commission.

 

Item 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

The primary objective of our investment activities is to preserve our capital until it is required to fund operations while at the same time maximizing the income we receive from our investments without significantly increasing risk. Our cash flow and earnings are subject to fluctuations due to changes in interest rates in our investment portfolio.  We maintain a portfolio of various issuers, types, and maturities.  These securities are classified as available-for-sale and, consequently, are recorded on the balance sheet at fair value with unrealized gains or losses reported as a component of accumulated other comprehensive loss included in stockholders’ equity.

 

 

 
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Item 4.    CONTROLS AND PROCEDURES

 

We have carried out an evaluation, under the supervision and with the participation of management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as that term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended.  Based on that evaluation, our principal executive officer and principal financial officer have concluded that, as of June 30, 2016, which is the end of the period covered by this report, our disclosure controls and procedures are effective at the reasonable assurance level in alerting them in a timely manner to material information required to be included in our periodic reports with the Securities and Exchange Commission.

 

There were no changes in our internal controls over financial reporting identified in connection with the evaluation required by paragraph (d) of Rule 13a-15 of the Securities Exchange Act of 1934, as amended, that occurred during the six months ended June 30, 2016 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

 

Our management, including our chief executive officer and chief financial officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.  

 

 

 
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PART II: OTHER INFORMATION

Item 1.    Legal Proceedings

 

None.

 

Item 1A.  Risk Factors

 

The following is a summary of the risk factors, uncertainties and assumptions that we believe are most relevant to our business. These are factors that, individually or in the aggregate, we think could cause our actual results to differ significantly from anticipated or historical results and our forward-looking statements. Additional risks that we currently believe are immaterial may also impair our business operations. Investors should carefully consider the risks described below before making an investment decision, and understand that it is not possible to predict or identify all such factors. Consequently, investors should not consider the following to be a complete discussion of all potential risks or uncertainties. Moreover, we operate in a competitive and rapidly changing environment.  New factors emerge from time to time and it is not possible to predict the impact of all of these factors on our business, financial condition or results of operations. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events, or otherwise.  The description provided in this Item 1A includes any material changes to and supersedes the description of the risk factors associated with our business previously disclosed in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed on March 30, 2016 with the Securities and Exchange Commission (SEC) and on Form 10-K/A for the fiscal year ended December 31, 2015 filed on April 29, 2016 with the SEC.  In assessing these risks, investors should also refer to the other information contained or incorporated by reference in this Quarterly Report and our other filings made from time to time with the SEC.

 

RISKS RELATED TO OUR BUSINESS

 

We have a history of significant losses from operations and expect to continue to incur significant losses for the foreseeable future.

 

Since our inception, our expenses have substantially exceeded our revenue, resulting in continuing losses and an accumulated deficit of $229 million at June 30, 2016. For the years ended December 31, 2013, 2014 and 2015 and the six months ended June 30, 2016, we incurred a net loss of $8.3 million, $25.5 million, $22.5 million and $10.2 million, respectively. We currently have no product revenue and do not expect to generate any product revenue for the foreseeable future other than through the sale of our proprietary reagent products for life science research, which products are based on our newly acquired proprietary delivery platform technologies, TheraPlas™ and TheraSilence™. Because we are committed to continuing our product research, development, clinical trial and commercialization programs, we will continue to incur significant operating losses unless and until we complete the development of ThermoDox®, GEN-1 and other new product candidates and these product candidates have been clinically tested, approved by the U.S. Food and Drug Administration (FDA) and successfully marketed. The amount of future losses is uncertain. Our ability to achieve profitability, if ever, will depend on, among other things, us or our collaborators successfully developing product candidates, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, establishing a sales and marketing organization or suitable third party alternatives for any approved product and raising sufficient funds to finance business activities. If we or our collaborators are unable to develop and commercialize one or more of our product candidates or if sales revenue from any product candidate that receives approval is insufficient, we will not achieve profitability, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

 

Drug development is an inherently uncertain process with a high risk of failure at every stage of development. Our lead drug candidate failed to meets its primary endpoint in the Phase III HEAT Study.

 

On January 31, 2013, we announced that our lead product ThermoDox® in combination with radiofrequency ablation (RFA) failed to meet the primary endpoint of the Phase III clinical trial for primary liver cancer, known as the HEAT Study. We have not completed our final analysis of the data and do not know the extent to which, if any, the failure of ThermoDox® to meet its primary endpoint in the Phase III trial could impact our other ongoing studies of ThermoDox® including a pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox® in combination with RFA in primary liver cancer, known as the OPTIMA Study, which we launched in the first half of 2014. The trial design of the OPTIMA Study is based on the overall survival data from the post-hoc analysis of results from the HEAT Study. ThermoDox® is also being evaluated in a Phase II clinical trial for recurrent chest wall breast cancer and other preclinical studies. In addition, we have initiated a Phase I dose-escalation clinical trial of GEN-1 in combination with the standard of care in neo-adjuvant ovarian cancer, known as the OVATION Study, and plan to expand our ovarian cancer development program to include a Phase I dose escalating trial evaluating GEN-1 in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer patients.

 

Preclinical testing and clinical trials are long, expensive and highly uncertain processes and failure can unexpectedly occur at any stage of clinical development, as evidenced by the failure of ThermoDox® to meet its primary endpoint in the HEAT Study. Drug development is inherently risky and clinical trials take us several years to complete. The start or end of a clinical trial is often delayed or halted due to changing regulatory requirements, manufacturing challenges, required clinical trial administrative actions, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparator drug or required prior therapy, clinical outcomes including insufficient efficacy, safety concerns, or our own financial constraints. The results from preclinical testing or early clinical trials of a product candidate may not predict the results that will be obtained in later phase clinical trials of the product candidate. We, the FDA or other applicable regulatory authorities may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects participating in such trials are being exposed to unacceptable health risks or adverse side effects. We may not have the financial resources to continue development of, or to enter into collaborations for, a product candidate if we experience any problems or other unforeseen events that delay or prevent regulatory approval of, or our ability to commercialize, product candidates. The failure of one or more of our drug candidates or development programs could have a material adverse effect on our business, financial condition and results of operations.

 

 

 
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If we do not obtain or maintain FDA and foreign regulatory approvals for our drug candidates on a timely basis, or at all, or if the terms of any approval impose significant restrictions or limitations on use, we will be unable to sell those products and our business, results of operations and financial condition will be negatively affected.

 

To obtain regulatory approvals from the FDA and foreign regulatory agencies, we must conduct clinical trials demonstrating that our products are safe and effective. We may need to amend ongoing trials or the FDA and/or foreign regulatory agencies may require us to perform additional trials beyond those we planned.  The testing and approval process requires substantial time, effort and resources, and generally takes a number of years to complete. The time to complete testing and obtaining approvals is uncertain, and the FDA and foreign regulatory agencies have substantial discretion, at any phase of development, to terminate clinical studies, require additional clinical studies or other testing, delay or withhold approval, and mandate product withdrawals, including recalls. In addition, our drug candidates may have undesirable side effects or other unexpected characteristics that could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restricted label or the delay or denial of regulatory approval by regulatory authorities. Even if we receive regulatory approval of a product, the approval may limit the indicated uses for which the drug may be marketed. The failure to obtain timely regulatory approval of product candidates, the imposition of marketing limitations, or a product withdrawal would negatively impact our business, results of operations and financial condition.

 

We do not expect to generate revenue for the foreseeable future.

 

We have devoted our resources to developing a new generation of products and will not be able to market these products until we have completed clinical trials and obtain all necessary governmental approvals. Our lead product candidate, ThermoDox® and the product candidates we purchased in our acquisition of EGEN, Inc., including GEN-1, are still in various stages of development and trials and cannot be marketed until we have completed clinical testing and obtained necessary governmental approval. Following our announcement on January 31, 2013 that the HEAT Study failed to meet its primary endpoint of progression free survival, we continued to follow the patients enrolled in the HEAT Study to the secondary endpoint, overall survival. Based on the overall survival data from the post-hoc analysis of results from the HEAT Study, we launched a pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox® in combination with RFA in primary liver cancer, known as the OPTIMA Study, in the first half of 2014. ThermoDox® is currently also being evaluated in a Phase II clinical trial for the treatment of recurrent chest wall breast cancer, known as the DIGNITY Study, and other preclinical studies. GEN-1 is currently in an early stage of clinical development for the treatment of ovarian cancer. We initiated a Phase I dose-escalation clinical trial of GEN-1 in combination with the standard of care in neo-adjuvant ovarian cancer in the second half of 2015 and plan to expand our ovarian cancer development program to include a Phase I dose escalating trial evaluating GEN-1 in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer patients . The delivery technology platforms, TheraPlas™ and TheraSilence™, are in preclinical stages of development. Accordingly, our revenue sources are, and will remain, extremely limited until our product candidates are clinically tested, approved by the FDA or foreign regulatory agencies and successfully marketed. We cannot guarantee that any of our product candidates will be approved by the FDA or any foreign regulatory agency or marketed, successfully or otherwise, at any time in the foreseeable future or at all.

   

We will need to raise substantial additional capital to fund our planned future operations, and we may be unable to secure such capital without dilutive financing transactions. If we are not able to raise additional capital, we may not be able to complete the development, testing and commercialization of our product candidates.

 

As of June 30, 2016, we had approximately $14.5 million in cash and cash equivalents. We have substantial future capital requirements to continue our research and development activities and advance our drug candidates through various development stages, including the product candidates and technology platforms that we purchased from EGEN, Inc. in June 2014. For example, ThermoDox® is being evaluated in a Phase III clinical trial in combination with RFA for the treatment of primary liver cancer, a Phase II clinical trial for the treatment of recurrent chest wall breast cancer and other preclinical studies. We initiated a Phase I dose-escalation clinical trial of GEN-1 in combination with the standard of care in neo-adjuvant ovarian cancer in the second half of 2015 and plan to expand our ovarian cancer development program to include a Phase I dose escalating trial evaluating GEN-1 in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer patients . We will continue to conduct additional analyses of the data from the HEAT Study to assess the future strategic value of ThermoDox® and are performing sub-group analysis of the Chinese cohort of patients in the HEAT Study and other activities for further development of ThermoDox® for mainland China, Hong Kong and Macau. To complete the development and commercialization of our product candidates, we will need to raise substantial amounts of additional capital to fund our operations. Our future capital requirements will depend upon numerous unpredictable factors, including, without limitation, the cost, timing, progress and outcomes of clinical studies and regulatory reviews of our proprietary drug candidates, our efforts to implement new collaborations, licenses and strategic transactions, general and administrative expenses, capital expenditures and other unforeseen uses of cash. We do not have any committed sources of financing and cannot assure you that alternate funding will be available in a timely manner, on acceptable terms or at all. We may need to pursue dilutive equity financings, such as the issuance of shares of common stock, convertible debt or other convertible or exercisable securities. Such dilutive equity financings could dilute the percentage ownership of our current common stockholders and could significantly lower the market value of our common stock. In addition, a financing could result in the issuance of new securities that may have rights, preferences or privileges senior to those of our existing stockholders.

 

 

 
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If we are unable to obtain additional capital on a timely basis or on acceptable terms, we may be required to delay, reduce or terminate our research and development programs and preclinical studies or clinical trials, if any, limit strategic opportunities or undergo corporate restructuring activities. We also could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights to some of our technologies, product candidates or potential markets or that could impose onerous financial or other terms. Furthermore, if we cannot fund our ongoing development and other operating requirements, particularly those associated with our obligations to conduct clinical trials under our licensing agreements, we will be in breach of these licensing agreements and could therefore lose our license rights, which could have material adverse effects on our business.

 

We may not successfully engage in future strategic transactions, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expense and present significant distractions to our management.

 

In the future, we may consider strategic alternatives intended to further the development of our business, which may include acquiring businesses, technologies or products, out- or in-licensing product candidates or technologies or entering into a business combination with another company. Any strategic transaction may require us to incur non-recurring or other charges, increase our near- and long-term expenditures and pose significant integration or implementation challenges or disrupt our management or business. These transactions would entail numerous operational and financial risks, including exposure to unknown liabilities, disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies, incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs, higher than expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses, difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business, impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership and the inability to retain key employees of any acquired business. Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and have a material adverse effect on our business, results of operations, financial condition and prospects. Conversely, any failure to enter any strategic transaction that would be beneficial to us could delay the development and potential commercialization of our product candidates and have a negative impact on the competitiveness of any product candidate that reaches market.

 

Strategic transactions, such as acquisitions, partnerships and collaborations, including the EGEN acquisition, involve numerous risks, including:

 

 •

the failure of markets for the products of acquired businesses, technologies or product lines to develop as expected;

 •

uncertainties in identifying and pursuing acquisition targets;

 •

the challenges in achieving strategic objectives, cost savings and other benefits expected from acquisitions;

 •

the risk that the financial returns on acquisitions will not support the expenditures incurred to acquire such businesses or the capital expenditures needed to develop such businesses;

 •

difficulties in assimilating the acquired businesses, technologies or product lines;

 •

the failure to successfully manage additional business locations, including the additional infrastructure and resources necessary to support and integrate such locations;

 •

the existence of unknown product defects related to acquired businesses, technologies or product lines that may not be identified due to the inherent limitations involved in the due diligence process of an acquisition;

 •

the diversion of management’s attention from other business concerns;

 •

risks associated with entering markets or conducting operations with which we have no or limited direct prior experience;

 •

risks associated with assuming the