Celsion Corporation
Celsion CORP (Form: 10-Q, Received: 11/05/2015 08:55:01)

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 September 30, 2015

 

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 November 4, 2015, the Registrant had 23,237,617 shares of common stock, $0.01 par value per share, outstanding.

   

 
 

 

 

CELSION CORPORATION

QUARTERLY REPORT ON

FORM 10-Q

 

TABLE OF CONTENTS

 

PART I:  FINANCIAL INFORMATION     

 

 

 

Page(s)

Item 1.

Financial Statements (Unaudited)

 

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations

2

 

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

23

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

33

 

 

 

Item 4.

Controls and Procedures

33

 

 

 

PART II:  OTHER INFORMATION     

 

 

 

 

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

49

Item 3.

Defaults Upon Senior Securities

49

Item 4.

Mine Safety Disclosures

49

Item 5.

Other Information

49

Item 6.

Exhibits

50

 

 

SIGNATURES     

51

 

 
 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, and its wholly-owned subsidiary CLSN Laboratories, Inc., also a Delaware corporation.

 

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

  

 

   

September 30 ,

2015

(unaudited)

   

December 31,

2014

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 7,574,875     $ 12,686,881  

Investment securities – available for sale, at fair value

    16,772,708       24,173,406  

Accrued interest receivable on investment securities

    24,619       210,030  

Advances, deposits and other current assets

    404,350       435,954  

Total current assets

    24,776,552       37,506,271  
                 

Property and equipment (at cost, less accumulated depreciation

of $1,957,517 and $1,633,517, respectively)

    954,688       1,170,497  
                 

Other assets:

               

In-process research and development

    25,801,728       25,801,728  

Goodwill

    1,976,101       1,976,101  

Deposits, deferred fees and other assets

    142,535       226,810  

Patent licensing fees, net

    7,500       13,125  

Total other assets

    27,927,864       28,017,764  
                 

Total assets

  $ 53,659,104     $ 66,694,532  

 

 

 

 

See accompanying notes to the financial statements.

 

 
1

 

 

CELSION CORPORATION

 

CONDENSED CONSOLIDATED

BALANCE SHEETS

(Continued)

 

 

   

September 30 ,

2015

(unaudited)

   

December 31,

2014

 
                 

LIABILITIES AND STOCKHOLDERS' EQUITY

               

Current liabilities:

               

Accounts payable – trade

  $ 2,503,700     $ 3,480,225  

Other accrued liabilities

    1,448,281       2,456,365  

Notes payable – current portion

    3,977,412       3,654,231  

Deferred revenue – current portion

    500,000       500,000  

Total current liabilities

    8,429,393       10,090,821  
                 

Earn–out milestone liability

    13,622,288       13,663,710  

Common stock warrant liability

          275,008  

Notes payable – non-current portion

    3,343,740       6,053,065  

Deferred revenue – non-current portion

    3,125,000       3,500,000  

Other liabilities - non-current

    55,503       286,592  
                 

Total liabilities

    28,575,924       33,869,196  
                 
                 

Stockholders' equity:

               

Preferred stock, $0.01 par value: 100,000 shares authorized; no shares issued or outstanding at September 30, 2015 and December 31, 2014, respectively

           

Common stock, $0.01 par value; 75,000,000 shares authorized; 23,111,603 and 20,097,603 shares issued at September 30, 2015 and December 31, 2014, and 23,027,988 and 19,984,203 shares outstanding at September 30, 2015 and December 31, 2014, respectively

    231,116       200,976  

Additional paid-in capital

    238,864,749       229,778,703  

Accumulated other comprehensive loss

    (1,034

)

    (16,032

)

Accumulated deficit

    (212,489,321

)

    (195,073,702

)

Subtotal

    26,605,510       34,889,945  

Treasury stock, at cost (83,615 and 113,400 shares at September 30, 2015 and December 31, 2014, respectively)

    (1,522,330

)

    (2,064,609

)

                 

Total stockholders' equity

    25,083,180       32,825,336  
                 

Total liabilities and stockholders' equity

  $ 53,659,104     $ 66,694,532  

 

 

 

   

 

See accompanying notes to the financial statements .

 

 
2

 

 

CELSION CORPORATION

 

CONDENSED CONSOLIDATED

STATEMENTS OF OPERATIONS

(Unaudited)

 

   

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
   

201 5

   

201 4

   

201 5

   

201 4

 
                                 

Licensing revenue

  $ 125,000     $ 125,000     $ 375,000     $ 375,000  
                                 

Operating expenses:

                               

Research and development

    2,883,453       4,629,628       10,957,560       10,688,269  

General and administrative

    1,483,661       2,044,163       5,317,344       6,783,228  

Acquisition costs

    –        119,996             1,187,263  

Total operating expenses

    4,367,114       6,793,787       16,274,904       18,658,760  
                                 

Loss from operations

    (4,242,114

)

    (6,668,787

)

    (15,899,904

)

    (18,283,760

)

                                 

Other (expense) income:

                               

Gain (loss) from change in valuation of common stock warrant liability

          96,830       (61,246

)

    81,243  

Gain from valuation of earn-out milestone liability

    282,950             41,422        

Investment income, net

    15,500       26,515       48,745       57,268  

Interest expense

    (322,696

)

    (418,711

)

    (1,075,258

)

    (912,539

)

Other (expense) income

    (1,053

)

    21,807       (985

)

    19,319  

Total other (expense) income, net

    (25,299

)

    (273,559

)

    (1,047,322

)

    (754,709

)

                                 

Net loss

  $ (4,267,413

)

  $ (6,942,346

)

  $ (16,947,226

)

  $ (19,038,469

)

                                 
                                 

Net loss per common share

                               

Basic and diluted

  $ (0.19

)

  $ (0.40

)

  $ (0.79

)

  $ (1.12

)

                                 
                                 

Weighted average shares outstanding

                               

Basic and diluted

    23,023,402       17,526,531       21,335,228       16,931,914  

 

 

 

 

 

 

See accompanying notes to the financial statements.

 

 
3

 

 

CELSION CORPORATION

 

 CONDENSED CONSOLIDATED

STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

 

 

 

 

   

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
   

201 5

   

201 4

   

201 5

   

201 4

 

Other comprehensive ( loss ) gain

                               
                                 

Net loss

  $ (4,267,413

)

  $ (6,942,346

)

  $ (16,947,226

)

  $ (19,038,469

)

                                 

Changes in:

                               

Realized (gain) loss on investment securities recognized in investment income, net

    (106

)

    (218

)

    104       23,473  
                                 

Unrealized gain (loss) on investment securities

    3,387       (14,025

)

    14,894       (5,379

)

                                 

Other comprehensive gain (loss)

    3,281       (14,243

)

    14,998       18,094  
                                 

Comprehensive loss

  $ (4,264,132

)

  $ (6,956,589

)

  $ (16,932,228

)

  $ (19,020,375

)

 

 

See accompanying notes to the financial statements.

 

 

 
4

 

 

 

CELSION CORPORATION

  

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

   

Nine Months Ended

September 30 ,

 
   

2015

   

2014

 

Cash flows from operating activities:

               

Net loss

  $ (16,947,226

)

  $ (19,038,469

)

Non-cash items included in net loss:

               

Depreciation and amortization

    329,625       262,125  

Change in fair value of common stock warrant liability

    61,246       (81,243

)

Change in fair value of earn-out milestone liability

    (41,422

)

     

Deferred revenue

    (375,000

)

    (375,000

)

Stock-based compensation

    1,616,864       2,253,636  

Shares issued out of treasury

    73,886       41,819  

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

    349,090       311,595  

Change in deferred rent liability

    (21,904

)

    (17,825

)

Loss realized on sale of investment securities

    104       23,473  

Net changes in:

               

Accrued interest on short term investments

    185,411       5,877  

Prepaid expenses, deposits and other assets

    31,604       (11,332

)

Accounts payable - trade

    (1,185,710

)

    2,714,365  

Accrued liabilities

    (1,008,084

)

    (932,504

)

Net cash used in operating activities

    (16,931,516

)

    (14,843,483

)

                 

Cash flows from investing activities:

               

Purchases of investment securities

    (21,078,733

)

    (29,175,818

)

Proceeds from sale and maturity of investment securities

    28,494,325       27,279,000  

Cash used in acquisition of EGEN, Inc. assets, net of cash received

          (2,849,760

)

Refund on security for letter of credit

    50,000       50,000  

Purchases of property and equipment

    (108,191

)

    (398,011

)

Net cash provided by (used in) investing activities

    7,357,401       (5,094,589

)

                 

Cash flows from financing activities:

               

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

    7,163,068       13,788,811  

Proceeds from note payable

          5,000,000  

Principal payments on notes payable

    (2,700,959

)

    (10,891

)

Net cash provided by financing activities

    4,462,109       18,777,920  
                 

Decrease in cash and cash equivalents

    (5,112,006

)

    (1,160,152

)

Cash and cash equivalents at beginning of period

    12,686,881       5,718,504  

Cash and cash equivalents at end of period

  $ 7,574,875     $ 4,558,352  
                 

Supplemental disclosures of cash flow information:

               

Fair value of common stock issued in acquisition of EGEN, Inc. assets

      $ 10,850,977  
                 

Interest paid

  $ 726,167     $ 605,100  

 

 

See accompanying notes to the financial statements.

 

 
5

 

 

CELSION CORPORATION

  

 NOTES TO THE CONDENSED CONSOLIDATED

  FINANCIAL STATEMENTS (UNAUDITED)

 

FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2015 AND 2014

 

 

Note 1.   Business Description

 

Celsion Corporation, a Delaware corporation based in Lawrenceville, New Jersey, and its wholly owned subsidiary, CLSN Laboratories, Inc., also a Delaware corporation, 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 and in Phase II development for the treatment of recurrent chest wall breast 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 and CLSN Laboratories, Inc., 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 nine month periods ended September 30, 2015 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 for the fiscal year ended December 31, 2014 filed on March 12, 2015 with the Securities and Exchange Commission (SEC).

 

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.   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 May 2014, the FASB issued Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Topic 606). This guidance is intended to improve and converge with international standards regarding the financial reporting requirements for revenue from contracts with customers. It will be effective for our first quarter of 2018 and early adoption is permitted. We are currently evaluating the impact of adoption of this new accounting pronouncement on our financial statements. 

 

 
6

 

 

In April 2015, the FASB issued Accounting Standards Update No. 2015-03 Interest – Imputation of Interest (Subtopic 835-30). This guidance is to simplify the presentation of debt issuance costs by recognizing a debt liability in the balance sheet as a direct deduction from that debt liability consistent with the presentation of a debt discount. It will be effective for our first quarter of 2016 and early adoption is permitted. We are currently evaluating the impact of adoption of this new accounting pronouncement on our financial statements. 

 

Note 4.   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 nine month periods ended September 30, 2015 and 2014, diluted loss attributable to common shareholders per common share was the same as basic loss attributable to common shareholders per common share as all options and 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. The total number of shares of common stock issuable upon exercise of warrants and equity awards were 8,110,136 for the three and nine month periods ended September 30, 2015 and were 8,188,708 for the three and nine month periods ended September 30, 2014.

 

Note 5.   Investment Securities - Available For Sale

 

Investment securities available for sale of $16,772,708 and $24,173,406 as of September 30, 2015 and December 31, 2014, respectively, consist of commercial paper and corporate debt securities.  They are valued at fair value, with unrealized gains and losses reported as a separate component of Stockholders’ Equity in Accumulated Other Comprehensive Loss.

 

Investment 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:

 

   

September 30 , 2015

   

December 31, 2014

 
   

Cost

   

Fair Value

   

Cost

   

Fair Value

 

Short-term investments

                               

Certificate of deposit

  $ 5,760,000     $ 5,761,018     $ 5,000,000     $ 4,996,568  

Bonds- corporate issuances

    11,013,742       11,011,690       19,189,438       19,176,838  

Total short-term investments

  $ 16,773,742     $ 16,772,708     $ 24,189,438     $ 24,173,406  

 

   

September 30 , 2015

   

December 31, 2014

 
   

Cost

   

Fair Value

   

Cost

   

Fair Value

 

Short-term investment maturities

                               

Within 3 months

  $ 5,962,090     $ 5,962,325     $ 16,881,490     $ 16,872,158  

Between 3-12 months

    10,811,652       10,810,383       7,307,948       7,301,248  

Total

  $ 16,773,742     $ 16,772,708     $ 24,189,438     $ 24,173,406  

 

 
7

 

 

The following table shows the Company’s investment securities with unrealized holding gains and losses and their fair value by investment category and length of time that individual securities have been in a continuous unrealized loss position at September 30, 2015 and December 31, 2014.  The Company has reviewed individual securities to determine whether a decline in fair value below the amortizable cost basis is other than temporary.

 

   

September 30 , 2015

   

December 31, 2014

 

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

  $ 6,564,384     $ 1,291     $     $  

Short-term investments with unrealized losses

    10,208,324       (2,326

)

    24,173,406       (16,032

)

Total

  $ 16,772,708     $ (1,034

)

  $ 24,173,406     $ (16,032

)

  

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

September 30,

 

Description of Securities

 

2015

   

2014

 
                 

Interest and dividends accrued and paid

  $ 29,610     $ 252,303  

Accretion of investment premium

    (14,216

)

    (226,006

)

Realized gains

    106       218  

Investment income, net

  $ 15,500     $ 26,515  

 

 

   

Nine Months Ended

September 30,

 

Description of Securities

 

2015

   

2014

 
                 

Interest and dividends accrued and paid

  $ 161,584     $ 833,315  

Accretion of investment premium

    (112,735

)

    (752,574

)

Realized losses

    (104

)

    (23,473

)

Investment income, net

  $ 48,745     $ 57,268  

 

The following table presents the change, by component, in accumulated other comprehensive loss for the first nine months of 2015. 

 

   

Accumulated Other

Comprehensive Loss

 

Balance at January 1, 2015

  $ (16,032

)

         

Unrealized gains on investment securities

    14,894  

Realized loss reclassified from other accumulated comprehensive loss

    104  

Net other comprehensive loss, net

    14,998  
         

Balance at September 30, 2015

  $ (1,034

)

 

 
8

 

   

Note 6.   Fair Value of Measurements

 

FASB Accounting Standards Codification (ASC) Section 820 (formerly SFAS No. 157) “ 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).

  

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 nine months ended September 30, 2015 except for the change in the fair market value of the warrant liability and the change in the earn-out milestone liability were included in earnings.

 

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 September 30, 2015

                               

Short-term investments available for sale

  $ 16,772,708     $ 16,772,708          
                                 

Recurring items as of December 31, 2014

                               

Short-term investments available for sale

  $ 24,173,406     $ 24,173,406          
                                 

Non-recurring items as of September 30, 2015 and December 31, 2014

                               

In-process research and development (Note 7)

  $ 25,801,728             $ 25,801,728  
                                 

Goodwill (Note 7)

  $ 1,976,101             $ 1,976,101  

 

 
9

 

 

   

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)

 

Liabilities:

                               

Recurring items as of September 30, 2015

                               

Common stock warrant liability (Note 13)

  $     $     $     $  
                                 

Earn-out milestone liability (Note 12)

  $ 13,622,288     $     $     $ 13,622,288  
                                 

Recurring items as of December 31, 2014

                               

Common stock warrant liability (Note 13)

  $ 275,008     $     $     $ 275,008  
                                 

Earn-out milestone liability (Note 12)

  $ 13,663,710     $     $     $ 13,663,710  

 

Note 7. Acquisition of EGEN, Inc.

 

On June 20, 2014, Celsion 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). CLSN Laboratories, Inc., a Delaware corporation and a wholly-owned subsidiary of Celsion (CLSN Laboratories), 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 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, Celsion paid approximately $3.0 million in cash after expense adjustment and issued 2,712,188 shares of its common stock to EGEN. The shares of common stock were issued in a private transaction exempt from registration under the Securities Act of 1933, as amended (the Securities Act), pursuant to Section 4(2) thereof. 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 (Holdback Shares). A registration statement (File No. 333-198786) was filed on September 16, 2014 and declared effective on September 30, 2014 for the resale of the shares of common stock issued and issuable to EGEN under the EGEN Purchase Agreement.

  

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 development milestones relating to the TheraSilence TM   technology acquired from EGEN in the acquisition.

 

On June 9, 2014, Celsion borrowed an additional $5 million pursuant to a certain Loan and Security Agreement dated as of November 25, 2013, by and between Celsion and Hercules Technology Growth Capital, Inc. (see Note 9).   Celsion used the loan proceeds to pay the upfront cash payment at closing and certain transaction costs incurred by Celsion in connection with the acquisition.

 

 
10

 

 

The EGEN Purchase Agreement contains customary representations and warranties regarding EGEN and Celsion, covenants regarding the conduct of EGEN’s business prior to the consummation of the acquisition, indemnification provisions, termination and other provisions customary for transactions of this nature.

 

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 determined as follows:

 

Consideration Paid at Closing

       

Cash, net of cash acquired

  $ 2,821,000  

Celsion common stock (2,712,188 shares valued at $3.48 which was the last closing price of our common stock at the time of closing the transaction on June 20, 2014)

    9,438,000  
         

Future Consideration

       

Holdback Shares (670,070 shares of Celsion common stock which were discounted by 38% to reflect the cost of the restriction)

    1,441,000  

Earn-out Payments (at fair value*)

    13,878,000  
         

Total fair value of consideration

  $ 27,578,000  

 

* The total aggregate purchase price for the acquisition of substantially all the assets of 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 September 30, 2015, the Company fair valued these milestones at $13.6 million and recognized a non-cash benefit of $41,422 as a result of the change in the fair value of these milestones from December 31, 2014.

 

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. There were no subsequent adjustments to provisional amounts in finalizing the purchase price allocation of acquisition of substantially all of the assets of Egen, Inc. on June 20, 2014. 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  

 

The purchase price exceeded the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as goodwill.

 

Acquired In-Process Research and Development (IPR&D)

 

Acquired 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 using the Multi-Period Excess Earnings Method (MPEEM) which is a form of the income approach. Under the MPEEM, the fair value of an intangible asset is equal to the present value of the asset’s incremental after-tax cash flows (excess earnings) remaining after deducting the market rates of return on the estimated value of contributory assets (contributory charge) over its remaining useful life.

 

 
11

 

 

To calculate fair value of the IPR&D programs under the MPEEM, we used projected cash flows discounted at a rate considered appropriate given the significant inherent risks associated with drug development by development-stage companies. Cash flows were calculated based on estimated projections of revenues and expenses related to the IPR&D programs and then reduced by a contributory charge on requisite assets employed. Contributory assets included debt-free working capital, net fixed assets and assembled workforce. Rates of return on the contributory assets were based on rates used for comparable market participants. Cash flows were assumed to extend through a seven-year market exclusivity period. The resultant cash flows were then discounted to present value using a weighted-average cost of equity capital for companies with profiles substantially similar to that of Celsion, which we believe represents the rate that market participants would use to value the assets. The projected cash flows were based on significant assumptions, including the indication in which we will pursue development of IPR&D programs, the time and resources needed to complete the development and regulatory approval of IPR&D programs, estimates of revenue and operating profit related to the program considering its stage of development, the life of the potential commercialized product, market penetration and competition, and risks associated with achieving commercialization, including delay or failure to obtain regulatory approvals to conduct clinical studies, failure of clinical studies, delay or failure to obtain required market clearances, and intellectual property litigation.

 

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. When performing our impairment assessment, we have the option to first assess qualitative factors to determine whether it is necessary to recalculate the fair value of our acquired IPR&D. If we elect this option and believe, as a result of the qualitative assessment, that it is more-likely-than-not that the fair value of our acquired IPR&D is less than its carrying amount, we calculate the fair value using the same methodology as described above. If the carrying value of our acquired IPR&D exceeds its fair value, then the intangible asset is written-down to its fair value. Alternatively, we may elect to not first assess qualitative factors and immediately recalculate the fair value of our acquired IPR&D. 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.

 

Pro Forma Information

 

The following unaudited pro forma information presents our condensed results of operations as if the acquisition of EGEN had occurred on January 1, 2014:

 

   

Three Months Ended

September 30,

 
   

2015

   

2014

 

Revenues

  $ 125,000     $ 125,000  

Loss from operations

    (4,242,114

)

    (6,548,791

)

Net loss applicable to common shareholders

    (4,267,413

)

    (6,822,350

)

 

   

Nine Months Ended

September 30,

 
   

2015

   

2014

 

Revenues

  $ 375,000     $ 375,000  

Loss from operations

    (15,899,904

)

    (18,665,291

)

Net loss applicable to common shareholders

    (16,947,226

)

    (19,404,768

)

 

The above unaudited pro forma condensed consolidated financial information is presented for illustrative purposes only. It is not necessarily indicative of what the results of operations actually would have been had the acquisition been completed on the date indicated. In addition, it does not purport to project the future operating results of the combined entity.

 

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 if we believe indicators of impairment exist. Such indicators could include, but are not limited to (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator. We first assessed qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount, including goodwill. If we conclude that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, we will conduct a two-step quantitative goodwill impairment test. 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.

   

 
12

 

 

Note 8. Accrued Liabilities

 

Other accrued liabilities at September 30, 2015 and December 31, 2014 include the following:

 

   

September 30 ,

2015

   

December 31,

2014

 

Amounts due to Contract Research Organizations and other contractual agreements

  $ 402,961     $ 857,730  

Accrued payroll and related benefits

    699,371       961,440  

Accrued professional fees

    257,500       502,300  

Accrued interest on notes payable

    68,429       96,875  

Other

    20,020       38,020  
                 

Total Accrued Liabilities

  $ 1,448,281     $ 2,456,365  

 

Note 9.  Note Payable

 

Hercules Credit Agreement

  

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. 

 

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). 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.

 

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.  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. A registration statement (File No. 333-193936) was filed on February 13, 2014, amended on September 16, 2014 and declared effective on September 30, 2014 for the resale of the shares of common stock issuable pursuant to the Hercules Warrant.

 

 
13

 

 

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 warrant, 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 warrant and concluded the original amount should be reclassified from deferred financing fees and equity as the warrant contains a provision which required the exercise price to be adjusted downward to a lower price at which time the Company would sell and issue shares in a financing for cash during the one-year anniversary of the date of issuance of the warrant. 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 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 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 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.  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 and nine month periods ended September 30, 2015, the Company incurred $218,836 and $726,168 in interest expense and amortized $103,860 and $349,090 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.

 

 
14

 

 

Following is a schedule of future principal payments before debt discount due on the Hercules Credit Agreement:

 

Principle payments before debt discount and end of term charges on the Hercules Credit Agreement

       
         

For the year period ending September 30, 2016

  $ 3,977,412  

For the year period ending September 30, 2017

    3,321,629  

Total

  $ 7,299,041  

 

Oxford & Horizon Credit Agreement

  

In June 2012, the Company entered into a Loan and Security Agreement (the Oxford & Horizon Credit Agreement) with Oxford Finance LLC (Oxford) and Horizon Technology Finance Corporation (Horizon). The Oxford & Horizon Credit Agreement provided for a secured term loan of up to $10 million, with 50% of any loans to be funded by Oxford and 50% to be funded by Horizon. The aggregate loan amount could have been advanced in two tranches of $5 million each. The first tranche (the Term A Loan) was made available to the Company on June 27, 2012 and the second tranche was to be made available, if at all, during the period beginning on the date that the Company achieved positive data in its Phase III clinical trial of RFA and ThermoDox® (the HEAT Study) and ending on March 31, 2013.  On January 31, 2013, the Company announced it did not meet the primary endpoint of the HEAT Study.   

 

The Term A Loan was originally scheduled to mature on October 15, 2015.  As a result of the Hercules Credit Agreement discussed above, the Company terminated the Oxford & Horizon Credit Agreement and repaid the outstanding principal, accrued interest and termination fees totaling approximately $4.1 million.

 

The proceeds of the Oxford & Horizon Credit Agreement were used to fund the Company’s working capital and general corporate purposes. The obligations under the Oxford & Horizon Credit Agreement were secured by substantially all assets of the Company other than its intellectual property and certain other agreed-upon exclusions.

 

As a fee in connection with the Oxford & Horizon Credit Agreement, the Company issued warrants to Horizon and Oxford (the Oxford & Horizon Warrants) to purchase the number of shares of the Company’s common stock equal to 3% of each loan amount divided by the exercise price of $13.14 per share, which was calculated as the average NASDAQ closing price of the Company’s common stock for the three days prior to the funding of the loan amount.  This resulted in 11,415 warrant shares issued in connection with the Term A Loan.  The Oxford & Horizon Warrants issued in connection with the Term A Loan are exercisable for cash or by net exercise and will expire seven years after their issuance, which is June 27, 2019.

 

Note 10. Stockholders’ Equity

 

May 2015 Common 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.

 

 
15

 

 

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.

 

January 2014 Common Stock Offering

 

On January 15, 2014, the Company 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 (the January 2014 Offering). The shares of common stock and warrants were sold in units, with each unit consisting of one share of common stock, a Series A warrant to purchase 0.25 share of common stock and a Series B warrant to purchase 0.25 share of common stock. Each unit was sold at a purchase price of $4.1625. Each Series A warrant will be exercisable during one year after its issuance date and until the five-year anniversary of the issuance date. Each Series B warrant was exercisable at any time on or after its issuance date had expired as of January 15, 2015. Each warrant has an exercise price of $4.10 per share.

 

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 the Company may offer and sell, from time to time, through Cantor, shares of its common stock having an aggregate offering price of up to $25.0 million (the ATM Shares) pursuant to the Shelf Registration Statement. 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 February 25, 2013, the Company sold and issued an aggregate of 1,195,927 shares of common stock under the ATM Agreement, receiving approximately $6.8 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. We have sold and issued an aggregate of 1,195,927 shares under the ATM Agreement as of September 30, 2015, receiving approximately $6.8 million in net proceeds. On October 2, 2015, we filed a prospectus supplement to the base prospectus that forms a part of the registration statement on Form S-3 (File No. 333-206789), 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 shares of common stock from time to time under the ATM Agreement.

 

February 2013 Preferred Stock Offering

 

On February 22, 2013, the Company entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in a registered offering, an aggregate of 15,000.00422 shares of its Series A 0% convertible preferred stock and the warrants to purchase shares of its common stock, for an aggregate purchase price of approximately $15.0 million (the February 2013 Preferred Stock Offering).  The closing of the February 2013 Preferred Stock Offering occurred on February 26, 2013, in which the Company received approximately $15.0 million in gross proceeds.  Subject to certain ownership limitations, shares of Series A 0% convertible preferred stock are convertible, at the option of the holder thereof, into an aggregate of up to 2,682,764 shares of common stock, and the warrants are exercisable to purchase an aggregate of up to 1,341,382 shares of common stock. Each warrant has an exercise price of $5.31 per share, equal to the closing bid price of common stock on February 21, 2013. The warrants were immediately exercisable and expire five years after the date of issuance.

 

 
16

 

 

During 2013, 2,682,764 shares of common stock in the aggregate were issued upon conversion of all of the 15,000.00422 shares of the Series A 0% convertible preferred stock.

 

Reverse Stock Split

 

On October 28, 2013, the Company effected a 4.5-to-1 reverse stock split of its common stock which was made effective for trading purposes as of the commencement of trading on October 29, 2013. As of October 28, 2013, each nine shares of issued and outstanding common stock and equivalents were combined and converted into two shares of common stock outstanding at the time of the reverse stock split.  

 

Note 11. 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.

 

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.  

 

 
17

 

 

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

 

 

 

Nine Months Ended

September 30,

 

 

 

2015

 

 

2014

 

Risk-free interest rate

 

2.06

2.93

%

 

2.63

2.75

%

Expected volatility

 

  92.9

93.0

%

 

  98.7

100.7

%

Expected life (in years)

 

 

 

10.00

 

 

 

 

10.00

 

Expected forfeiture rate

 

 

 

5.0

 

 

 

5.0

%

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 as published in the Wall Street Journal 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 expected life of the fiscal 2015 and 2014 grants was generated using the simplified method.

 

A summary of the Company’s stock option and restricted stock awards for the nine months ended September 30, 2015 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, 2014

    1,744,755     $ 7.20       7,018     $ 3.32          

Equity awards granted

    709,250     $ 2.44       43,500     $ 3.29          

Equity awards exercised

                (14,000

)

  $ 2.72          

Equity awards forfeited, cancelled or expired

    (275,062

)

  $ 9.65                      
                                         

Equity awards outstanding at September 30, 2015

    2,178,943     $ 5.34       36,518     $ 3.51       7.6  
                                         

Aggregate intrinsic value of outstanding awards at September 30, 2015

  $             $ 110,853                  
                                         

Equity awards exercisable at September 30, 2015

    1,467,857     $ 7.25                       7.2  
                                         

Aggregate intrinsic value of awards exercisable at September 30, 2015

  $                                  

 

Total compensation cost related to employee stock options and restricted stock awards amounted to $289,683 and $532,160 for the three months ended September 30, 2015 and 2014, respectively.  Total compensation cost related to employee stock options and restricted stock awards amounted to $1,616,864 and $2,253,636 for nine months ended September 30, 2015 and 2014, respectively. No compensation cost related to share-based payments arrangements was capitalized as part of the cost of any asset as of September 30, 2015 and 2014.

 

As of September 30, 2015, there was $0.9 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 1.3 years. The weighted average grant-date fair value was $2.15 and $3.18 per share for the options granted during the nine months ended September 30, 2015 and 2014, respectively.  The weighted average grant-date fair value was $3.29 and $3.49 for the restricted stock awards granted during the nine months ended September 30, 2015 and 2014, respectively.  

 

 
18

 

 

Collectively, for all of the Company’s stock option plans as of September 30, 2015, there were a total of 3,660,270 shares reserved with 2,215,461 equity awards granted and 1,444,809 equity awards available for future issuance. 

 

Note 12. 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 7.0 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. At September 30, 2015, the Company fair valued the earn-out milestone liability at $13.6 million and recognized a non-cash benefit of $282,950 and $41,422 during the three and nine month periods ended September 30, 2015, respectively, as a result of the change in the fair value of earn-out milestone liability from $13.9 million and $13.7 million at June 30, 2015 and December 31, 2014, respectively.

 

The fair value of the earn-out milestone liability at September 30, 2015 was based on the Company's risk-adjusted assessment of each milestone (10% to 75%) utilizing a discount rate based on the estimated time to achieve the milestone (0.8 to 2.8 years). The fair value of the earn-out milestone liability at December 31, 2014 was based on the Company's risk-adjusted assessment of each milestone (10% to 67%) utilizing a discount rate based on the estimated time to achieve the milestone (1.2 to 6.5 years).

 

The following is a summary of the changes in the earn-out milestone liability for 2015:

 

Balance at January 1, 2015

  $ 13,663,710  

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

    (41,422

)

Balance at September 30, 2015

  $ 13,622,288  

 

Note 13. Warrants

 

Common Stock Warrants

 

Following is a summary of all warrant activity for the nine months ended September 30, 2015: 

 

Warrants

 

Number of

Warrants

Issued

   

Weighted

Average

Exercise Price

 
                 

Warrants outstanding at December 31, 2014

    5,069,815     $ 8.18  
                 

Warrants issued during the nine months ended September 30, 2015

    1,950,000     $ 2.60  
                 

Warrants expired during the nine months ended September 30, 2015

    (1,125,140

)

  $ 7.98  

Warrants outstanding at September 30, 2015

    5,894,675     $ 6.37  
                 

Aggregate intrinsic value of outstanding warrants at September 30, 2015

             
                 

Weighted average remaining contractual terms (in years)

    3.0          

 

 

 
19

 

   

In September 2009, the Company closed a registered direct offering with a select group of institutional investors that raised gross proceeds of $7.1 million and net proceeds of $6.3 million.  In connection with this registered direct offering, the Company issued 448,478 shares of its common stock and warrants to purchase 224,239 shares of common stock. On March 31, 2015, all unexercised warrants associated with this registered direct offering expired. As discussed in Note 10, the Series B warrants to purchase 900,901 shares of common stock issued in connection with the January 2014 Offering expired in January 2015.

 

Common Stock Warrant Liability

 

As of December 31, 2014, the Company recorded a common stock warrant liability of $275,008. The fair value of the warrants associated with the September 2009 registered direct offering at December 31, 2014 and the warrants associated with the Hercules loan, as more fully described in Note 9, at December 31, 2014 was calculated using the Black-Scholes option-pricing model with the following assumptions:

  

 

 

December 31,
2014

 

Risk-free interest rate

 

 

 0.04

-

1.66

%

Expected volatility

 

 

 40.9

-

98.35

%

Expected life (in years)

 

 

 0.25

-

3.9

 

Expected forfeiture rate

 

 

 

 

0.0

%

Expected dividend yield

 

 

 

 

0.00

%

 

Under the terms of the warrants associated with the September 2009 registered direct offering, upon certain transactions, including a merger, tender offer or sale of all or substantially all of the assets of the Company, each warrant holder could have elected to receive a cash payment in exchange for the warrant, in an amount determined by application of the Black-Scholes option valuation model. Accordingly, pursuant to ASC 815.40, Derivative Instruments and Hedging - Contracts in Entity’s Own Equity, the warrants were recorded as a liability and marked to market each period through the Statement of Operations in other income or expense. At the end of each subsequent quarter, the Company revalued the fair value of the warrants and the change in fair value was recorded as a change to the warrant liability and the difference was recorded through the Statement of Operations in other income or expense. The warrants expired in March 2015.

 

As discussed in Note 9, the Company concluded in the second quarter of 2015 the warrant provision which required the exercise price of the warrant to be adjusted downward to a lower price at which the Company would sell and issue shares in a financing for cash during the one-year anniversary of the warrant had expired. Therefore, the Company valued the warrant at $336,254 immediately prior to this event using a risk-free interest rate of 1.98%, expected volatility of 99.71%, an expected remaining life of 4 years and no forfeiture nor dividends expected. The Company 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, and reduced the liability to zero and increased equity by $336,254 at this time.

 

The following is a summary of the changes in the common stock warrant liability for the nine month period ended September 30, 2015:

 

Beginning balance as of January 1, 2015

  $ 275,008  

Loss from the adjustment for the change in fair value included in net loss

    61,246  

Fair value of warrants reclassified as equity (Note 9)

    (336,254

)

Ending balance as of September 30, 2015

  $  

 

Note 14. Contingent Liabilities and Commitments

 

In July 2011, the Company, as a tenant, and a landlord executed a lease (the Lease) 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 free rent; with the first monthly rent payment of approximately $23,000 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 term of the Lease has expired. In connection with two $50,000 reductions of the standby letter of credit in April 2013 and 2014, the Company reduced the escrow deposit by $50,000 each time. The Company received the third and final reduction in April 2015.

 

 
20

 

 

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 32 months with monthly rent payments of approximately $23,200.

 

Note 15. 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.

 

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.

 

 
21

 

 

Development, Product Supply and Commercialization Agreement with Yakult Honsha

 

In the fourth quarter of 2008, the Company entered into a Development, Product Supply and Commercialization Agreement with Yakult Honsha Co. LTD (Yakult) under which Yakult was granted the exclusive right to commercialize and market ThermoDox® for the Japanese market.  We were paid a $2.5 million up-front licensing fee and we have the potential to receive additional payments from Yakult upon receipt of marketing approval by the Japanese Ministry of Health, Labor and Welfare as well as upon the achievement of certain levels of sales and approval for new indications. We will receive double digit escalating royalties on the sale ThermoDox® in Japan, when and if any such sales occur.  We also will be the exclusive supplier of ThermoDox® to Yakult.

 

In January 2011, the Company amended its Development, Product Supply and Commercialization Agreement with Yakult to provide for up to $4.0 million in an accelerated partial payment to the Company of a future drug approval milestone, which included $2.0 million paid to the Company upon the closing of the preferred equity financing the Company conducted in January 2011 and an additional $2.0 million conditioned upon the resumption of enrollment of Japanese patients in the Japan cohort of the HEAT Study.  In consideration of these accelerated milestone payments from Yakult, the Company agreed to reduce future drug approval milestone payments by approximately 40%.

 

License and Distribution Agreement

 

On January 20, 2015 the Company announced it had signed a license and distribution agreement with myTomorrows to implement an Early Access Program for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin, in all countries of the European Union (EU) territory, Iceland, Liechtenstein, Norway and Switzerland for the treatment of patients with recurrent chest wall (RCW) breast cancer. On August 10, 2015 the Company announced it had expanded its Early Access Program with myTomorrows to include patients with primary liver cancer, also known as hepatocellular carcinoma (HCC) and liver cancer metastases, in all countries of the European Union (EU) territory, Switzerland, Turkey and Israel. 

 

Early Access Programs allow biopharmaceutical companies to provide eligible patients with ethical access to investigational medicines for unmet medical needs within the scope of the existing early access legislation.  Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available to these patients.  Celsion will provide ThermoDox® to centers of excellence in the EU and Switzerland through its Early Access Program with myTomorrows, at prices that are comparable to chemotherapeutics used to treat this and other aggressive form of cancer.  

 

 
22

 

 

 

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, 2014 filed on March 12, 2015 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 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 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). Our pipeline also includes GEN-1 (formerly known as EGEN-001), 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. 

 

ThermoDox®

 

Our lead product ThermoDox® is being evaluated in a Phase III clinical trial for primary liver cancer (the OPTIMA study) which was initiated in the first half of 2014 and a Phase II clinical trial for recurrent chest wall breast cancer (the DIGNITY Studies). 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 mild hyperthermia temperatures (greater than 39.5° Celsius) releases the encapsulated doxorubicin from the liposome enabling high concentrations of doxorubicin to be deposited preferentially in and around the targeted tumor.

 

 
23

 

 

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 (PFS) for the 701 patient clinical trial in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer (the HEAT Study). Specifically, we determined, after conferring with the HEAT Study independent Data Monitoring Committee (iDMC), that the HEAT study did not meet the goal of demonstrating persuasive evidence of clinical effectiveness 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 continue to follow patients for overall survival (OS), the secondary endpoint of the HEAT Study, on a quarterly basis. We have conducted a comprehensive analysis of the data from the HEAT Study to assess the future strategic value of ThermoDox®. As part of this analysis, we also evaluated our product pipeline and research and development priorities. In April 2013, we announced the deferral of expenses associated with the Company’s Phase II study of ThermoDox® in combination with RFA for the treatment of colorectal liver metastases.

 

The data from the HEAT Study post-hoc analysis suggest that ThermoDox® may substantially improve overall survival, 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 seven 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 clinical benefit with progressive improvement in statistical significance. The most recent post-hoc OS analysis data from the HEAT Study as of July 15, 2015 (announced on August 6, 2015) demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 58% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this latest quarterly OS analysis is 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. Median overall survival for the ThermoDox® group has been reached which translates into a 25.4 month (2.1 year) survival benefit over the optimized RFA only group (79 months for the ThermoDox® plus optimized RFA group versus 53.6 months for the optimized RFA only group). These data continue to support the protocol for the Phase III OPTIMA Study, which is evaluating ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The study is expected to enroll up to 550 patients globally in up to 75 clinical sites in the United States, Europe, China and elsewhere in the Asia Pacific region.

 

Data from the HEAT Study post-hoc analysis have been presented at multiple scientific and medical conferences in 2013, 2014 and thus far in 2015 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 50th Annual Meeting in June 2014

 

Asian Conference on Tumor Ablation in October 2015

 

We also completed computational modeling with supplementary preclinical animal studies supporting the relationship between heating duration and clinical outcomes.

 

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 without comment, subject to compliance with regulatory standards, 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 an approximate 58% improvement in overall survival 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, 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 overall survival, and the secondary endpoints for the trial are PFS and Safety. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

 

In addition, the Company has met with the China State Food and Drug Administration (CHINA FDA) to discuss the OPTIMA Phase III Study including minimum patient enrollment requirements supporting the registration of ThermoDox® in China. Based on those discussions, we have submitted an application for accelerated approval of the OPTIMA Study in China. We also filed a request for a Voluntary Harmonization Procedure (VHP) in Europe, which provides for the assessment of multinational clinical trial applications across several European countries, including Germany, Italy and Spain.  Our request for a VHP in Europe was approved on October 23, 2014.

 

 
24

 

 

The DIGNITY Study. On July 6, 2015, we announced positive interim data from the DIGNITY Trial of ThermoDox® in recurrent chest wall (RCW) breast cancer.  The trial is designed to enroll up to 20 patients at five clinical sites in the United States and is evaluating ThermoDox® in connection with mild hyperthermia. Of the 17 patients enrolled and treated in the DIGNITY Study, 13 were eligible for evaluation of efficacy. Based on data available to date, every patient experienced a clinical benefit of their highly refractory disease with a local response rate of 69% observed in the 13 evaluable patients, notably five complete responses, four partial responses and four patients with stable disease.  The Company remains on track to complete enrollment in the study in the third quarter of 2015 and will present the final results at the San Antonio Breast Cancer Conference on December 12, 2015. These data are consistent with the previously reported Phase 1 data for ThermoDox® plus hyperthermia in RCW breast cancer, including combined clinical data from the Company's Phase 1 DIGNITY Study and a Duke University sponsored Phase 1 trial of ThermoDox®. The two similarly designed studies enrolled patients with highly resistant tumors found on the chest wall and who had progressed on previous therapies.  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% was reported in 14 of the 23 evaluable patients, with five complete responses and nine partial responses.

 

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. CLSN Laboratories, Inc., a Delaware corporation and a wholly-owned subsidiary of ours (CLSN Laboratories), 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 included 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:

  

 

$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 development milestones relating to the TheraSilence TM   technology acquired from EGEN in the acquisition.

 

On June 9, 2014, Celsion borrowed an additional $5 million pursuant to a certain Loan and Security Agreement dated as of November 25, 2013, by and between Celsion and Hercules Technology Growth Capital, Inc.  Celsion used the loan proceeds to pay the upfront cash payment to EGEN at closing and certain transaction costs incurred in connection with the acquisition.

  

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.  The preliminary purchase price exceeds the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as goodwill.

 

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. There were no subsequent adjustments to provisional amounts in finalizing the purchase price allocation of acquisition of substantially all of the assets of EGEN on June 20, 2014. 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  

   

 
25

 

 

GEN-1 OVATION Study. In February 2015, we announced that the FDA accepted, without comment, 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 we enrolled the first patient in the Ovation Study. The Ovation Study will seek to identify a safe, tolerable and 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 affects 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. 

 

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 first half of 2016.

 

Early Access Program. 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 (the Territory) 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 countries of the European Union territory, Switzerland, Turkey and Israel. 

 

Under the Early Access Agreement, we granted to Impatients, specifically for the treatment of RCW breast cancer in the Territory, an exclusive, royalty-free right to perform the early access program activities, reference regulatory documentation and approvals that we own, and use our trademarks relating to ThermoDox®. In addition, we granted to Impatients an option to negotiate an exclusive license to distribute ThermoDox® in the Territory after ThermoDox®   receives regulatory approval in a country within the Territory.

 

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.

 

To the extent that we are dependent on the success of one or a few product candidates, results such as those announced in relation to the HEAT Study on January 31, 2013 will have a more significant impact on our financial prospects, financial condition and market value. As demonstrated by the HEAT Study results in January 2013, drug research and development is an inherently uncertain process and there is a high risk of failure at every stage prior to approval. The timing and the outcome of clinical results is extremely difficult to predict. Clinical development successes and failures can have a disproportionate positive or negative impact on our scientific and medical prospects, financial prospects, results of operations, financial condition and market value. 

 

 
26

 

 

Funding Overview

 

To support our research and development, we have raised gross proceeds of approximately $118 million in equity financings and warrant and option exercises in the years 2009 through 2014 and thus far in 2015.

 

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 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. 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. 

 

In November 2013, we entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. (Hercules) which permits us to borrow up to $20 million in multiple tranches (the Hercules Credit Agreement). We currently have up to $10 million remaining under this facility. We drew the first tranche of $5 million upon closing of the Hercules Credit Agreement in November 2013 and used approximately $4.0 million of the proceeds to repay the then outstanding obligations under our former loan agreement with Oxford Finance LLC and Horizon Technology Finance Corporation. On June 9, 2014, we closed the second $5 million tranche under the Hercules Credit Agreement and used the proceeds to fund the $3.1 million upfront cash payment associated with the acquisition of EGEN, as well as our transaction costs associated with that acquisition. Upon the closing of the second tranche, we had drawn down a total of $10 million under the Hercules Credit Agreement.

 

On May 6, 2012, we entered into a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun) for the production of ThermoDox® in mainland China, Hong Kong and Macau (the China territory). Hisun will be responsible for providing all of the technical and regulatory support services for the manufacture of ThermoDox® in the China territory and we will repay Hisun the related development costs and fees, which we expect to be approximately $2.0 million in total, commencing on the successful completion of three registrational batches of ThermoDox®. On January 18, 2013, we broadened our relationship with Hisun by entering into a technology development contract, pursuant to which Hisun paid us a non-refundable research and development fee of $5.0 million to support our development of ThermoDox® and we will provide research data and other technical support in relation to a regulatory filing by Hisun in China for approval of ThermoDox®. Following our announcement of the HEAT Study results on January 31, 2013, we 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 the next steps in relation to ThermoDox®, which include the continued subgroup analysis of the Chinese cohort of patients in the HEAT Study for primary liver cancer and other activities to further the development of ThermoDox® for the China territory.

 

On July 19, 2013, we entered into a Memorandum of Understanding with Hisun 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. 

 

As a result of the risks and uncertainties discussed in this Quarterly Report on Form 10-Q, among others, we are unable to estimate the duration and completion costs of our research and development projects or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product. Our inability to complete any of our research and development activities, preclinical studies or clinical trials in a timely manner or our failure to enter into collaborative agreements when appropriate could significantly increase our capital requirements and could adversely impact our liquidity. While our estimated future capital requirements are uncertain and could increase or decrease as a result of many factors, including the extent to which we choose to advance our research, development activities, preclinical studies and clinical trials, or if we are in a position to pursue manufacturing or commercialization activities, we will need significant additional capital to develop our product candidates through development and clinical trials, obtain regulatory approvals and manufacture and commercialize approved products, if any. We do not know whether we will be able to access additional capital when needed or on terms favorable to us or our stockholders. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.

 

 
27

 

 

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 NINE MONTHS ENDED SEPTEMBER 30, 2015 AND 2014

 

Results of Operations

 

For the three months ended September 30, 2015, our net loss was $4.3 million compared to a net loss of $6.9 million for the same period of 2014. For the nine months ended September 30, 2015, our net loss was $16.9 million compared to a net loss of $19.0 million for the same period of 2014. As of September 30, 2015, we had $24.4 million in cash and short-term investments including accrued interest from short term investments.

 

   

Three Months Ended September 30,

 
   

(In thousands)

   

Change

Increase (Decrease)

 
   

201 5

   

201 4

           

%

 
                                 

Licensing Revenue:

  $ 125     $ 125     $ –        – 

%

                                 

Operating Expenses:

                               

Clinical Research

    1,888       4,012       (2,124

)

    (52.9

)%

Chemistry, Manufacturing and Controls

    995       618       377       61.0

%

Research and development

    2,883       4,630       (1,747

)

    (37.7

)%

General and administrative

    1,484       2,044       (560

)

    (27.4

)%

Acquisition costs

    –        120       (120

)

    (100.0

)%

Total operating expenses

    4,367       6,794       (2,427

)

    (35.7

)%

                                 

Loss from operations

  $ (4,242

)

  $ (6,669

)

  $ 2,427       36.4

%

 

 
28

 

 

   

Nine Months Ended September 30,

 
   

(In thousands)

   

Change

Increase (Decrease)

 
   

201 5

   

201 4

           

%

 
                                 

Licensing Revenue:

  $ 375     $ 375     $ –        – 

%

                                 

Operating Expenses:

                               

Clinical Research

    8,265       7,824       441       5.6

%

Chemistry, Manufacturing and Controls

    2,693       2,864       (171

)

    (6.0

)%

Research and development

    10,958       10,688       270       2.5

%

General and administrative

    5,317       6,783       (1,466

)

    (21.6

)%

Acquisition costs

    –        1,188       (1,188

)

    (100.0

)%

Total operating expenses

    16,275       18,659       (2,384

)

    (12.8

)%

                                 

Loss from operations

  $ (15,900

)

  $ (18,284

)

  $ 2,384       13.0

%

 

Comparison of the Three Months ended September 30, 2015 and 2014

 

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 first, second and third quarters of 2015 and 2014.

  

Research and Development Expenses

 

Research and development (R&D) expenses decreased by $1.7 million to $2.9 million in the third quarter of 2015 from $4.6 million in the same period of 2014.  Costs associated with the OPTIMA Study were $1.0 million in the third quarter of 2015 compared to $2.2 million in the same period of 2014 when we began initiating sites and enrolling patients in the OPTIMA Study. Study costs associated with the HEAT Study remained relatively insignificant in each of the third quarters of 2015 and 2014. 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 remained relatively unchanged at $0.1 million in each of the third quarters of 2015 and 2014. Other clinical costs were $0.4 million and $0.5 million in the third quarters of 2015 and 2014, respectively. Other R&D costs were $0.9 million lower in the third quarter of 2015 compared the same period of 2014 as the Company adjusted down $0.8 million of liability as the result of an amendment to a cooperative research and development agreement.  Costs associated with the production of clinical supplies of ThermoDox® to support the OPTIMA Study were $1.0 million in the third quarter of 2015 compared to $0.6 million in the same period of 2014.

 

During the second half of 2014, the Company completed the integration of the operations of the business acquired on June 20, 2014 from EGEN, Inc. into our wholly owned subsidiary, CLSN Laboratories. Costs associated with CLSN Laboratories were $0.9 million for the third quarter of 2015 compared to $0.7 million in the same period of 2014.

 

General and Administrative Expenses

 

General and administrative (G&A) expenses decreased by $0.5 million to $1.5 million in the third quarter of 2015 compared to $2.0 million in the same period of 2014. This decrease is primarily the result of decreases in personnel related costs of $0.3 million and insurance costs of $0.2 million.

 

 

 
29

 

   

Acquisition Transaction Related Expenses

 

We recognized transaction-related expenses for the three months ended September 30, 2014 which consisted of legal and professional fees related to the June 20, 2014 acquisition of substantially all of the assets of EGEN.

 

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 September 30, 2015, the Company fair valued these milestones at $13.6 million and recognized non-cash benefit of $0.3 million as a result of the change in the fair value of these milestones from $13.9 million at June 30, 2015.

 

Change in Warrant Liabilities

 

A warrant liability was incurred as a result of warrants we issued in a public offering in September 2009. On March 30, 2015, all remaining warrants associated with this equity offering expired. The liability associated with these warrants was calculated at its fair market value using the Black-Scholes option-pricing model and was adjusted at the end of each quarter with changes in fair value recorded in earnings during the term of the warrants. The warrants expired in March 2015. These warrants’ fair value was zero at December 31, 2014 and when they expired at March 31, 2015. Therefore, no change in warrant liability was required to be recorded or reclassified during 2015. For the three months ended September 30, 2014, there was no change in the liability associated with these warrants.

 

In addition, we issued warrants for 194,986 shares of the Company’s common stock in connection with the Hercules Credit Agreement in November 2013 and June 2014. The liability associated with these warrants was calculated at its fair market value using the Black-Scholes option-pricing model and was adjusted at the end of each quarter with changes in fair value recorded in earnings during the term of the warrants.  As discussed in Note 9 of the financial statement, the Company concluded in the second quarter of 2015 the warrant provision which required the exercise price of the warrant to be adjusted downward to a lower price at which the Company would sell and issue shares in a financing for cash during the one-year anniversary of the warrant had expired. Therefore, the Company valued the warrant at $336,254 immediately prior to this event and reduced the liability to zero and increased equity by $336,254 in the second quarter of 2015. The Company also recorded a non-cash charge to net income of $61,246 in the nine month period ended September 30, 2015.

 

At September 30, 2014, the fair value of these liabilities was $0.4 million and the resulting benefit was approximately $0.1 million in each of the three and nine month periods ended September 30, 2014.

 

Investment income and interest expense

 

In connection with its debt facilities the Company incurred $0.3 million and $0.4 million in interest expense in the three month periods ended September 30, 2015 and 2014, respectively.

 

Other (expense) income

 

Other (expense) income for the third quarters of 2015 and 2014 was not significant. 

 

Comparison of the Nine Months ended September 30, 2015 and 2014

 

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 $375,000 in each of the first nine months of 2015 and 2014.

    

 
30

 

 

Research and Development Expenses

 

Research and development (R&D) expenses increased by $0.3 million to $11.0 million in the first nine months of 2015 from $10.7 million in the same period of 2014.  Costs associated with the OPTIMA Study were $2.8 million in the first nine months of 2015 compared to $3.8 million in the same period of 2014 when we initiated the OPTIMA Study. Study costs associated with the HEAT Study were $0.3 million in the first nine months of 2015 compared to $0.4 million in the same period of 2014. 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 $0.2 million in the first nine months of 2015 compared to $0.3 million in the same period of 2014. Other clinical costs were $1.5 million in the first nine months of 2015 compared to $1.4 million in the same period of 2014. Other R&D costs were $0.2 million in the first nine months of 2015 compared to $1.1 million in the same period of 2014 as the Company adjusted down $0.8 million of liability as the result of an amendment to a cooperative research and development agreement.  Costs associated with the production of clinical supplies of ThermoDox® to support the OPTIMA Study were $2.7 million in the first nine months of 2015 compared to $2.9 million in the same period of 2014.

 

During the 2 nd half of 2014, the Company completed the integration of the operations of the business acquired on June 20, 2014 from EGEN, Inc. into our wholly owned subsidiary, CLSN Laboratories. Costs associated with CLSN Laboratories were $3.3 million in the first nine months of 2015 compared to $0.9 million in the same period of 2014.

 

General and Administrative Expenses

 

General and administrative (G&A) expenses decreased by $1.5 million to $5.3 million in the first nine months of 2015 compared to $6.8 million in the same period of 2014. This decrease is primarily the result of decreases in personnel costs of $0.8 million, insurance costs of $0.7 million and other administrative costs of $0.2 million partially offset by an increase of $0.2 million in legal fees associated with trademarks and patents associated with the product pipeline acquired in the EGEN acquisition.

 

Acquisition Transaction Related Expenses

 

We recognized transaction-related expenses of $1.2 million for the nine months ended September 30, 2014 which consisted of legal and professional fees related to the June 20, 2014 acquisition of substantially all of the assets of EGEN.

 

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 September 30, 2015, the Company fair valued these milestones at $13.6 million and recognized non-cash benefit of $41,422 as a result of the change in the fair value of these milestones from $13.7 million at December 31, 2014.

 

Change in Warrant Liabilities

 

A warrant liability was incurred as a result of warrants we issued in a public offering in September 2009. On March 30, 2015, all remaining warrants associated with this equity offering expired. The liability associated with these warrants was calculated at its fair market value using the Black-Scholes option-pricing model and was adjusted at the end of each quarter with changes in fair value recorded in earnings during the term of the warrants. The warrants expired in March 2015. These warrants’ fair value was zero at December 31, 2014 and when they expired at March 31, 2015. Therefore, no change in warrant liability was required to be recorded or reclassified during 2015. For the first nine months of 2014, the Company recorded a non-cash benefit of $3,026 for these warrants.

 

In addition, we issued warrants for 194,986 shares of the Company’s common stock in connection with the Hercules Credit Agreement in November 2013 and June 2014. The liability associated with these warrants was calculated at its fair market value using the Black-Scholes option-pricing model and was adjusted at the end of each quarter with changes in fair value recorded in earnings during the term of the warrants.  As discussed in Note 9 of the financial statement, the Company concluded in the second quarter of 2015 the warrant provision which required the exercise price of the warrant to be adjusted downward to a lower price at which the Company would sell and issue shares in a financing for cash during the one-year anniversary of the warrant had expired. Therefore, the Company valued the warrant at $336,254 immediately prior to this event and reduced the liability to zero and increased equity by $336,254 in the second quarter of 2015. The Company also recorded a non-cash charge to net income of $61,246 in the nine month period ended September 30, 2015.

 

 
31

 

 

At September 30, 2014, the fair value of these liabilities was $0.4 million and the Company recorded a non-cash benefit to net income of $81,243 in the nine month period ended September 30, 2014.

 

Investment income and interest expense

 

In connection with its debt facilities the Company incurred $1.1 million and $0.9 million in interest expense in the first nine months of 2015 and 2014, respectively.