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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, 2023

 

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

 

Imunon, Inc.

(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)

 

Securities registered pursuant to Section 12(b) of the Act

 

Title of each class   Trading symbol(s)   Name of each exchange on which registered
Common stock, par value $0.01 per share   IMNN   Nasdaq Capital Market

 

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 every Interactive Data File required to be submitted 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 such files). Yes ☒ No ☐

 

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

 

  Large accelerated filer ☐ Accelerated filer ☐
  Non-accelerated filer Smaller reporting company
  Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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 9, 2023, the Registrant had 9,399,289 shares of common stock, $0.01 par value per share, outstanding.

 

 

 

 
 

 

IMUNON, INC.

 

QUARTERLY REPORT ON

FORM 10-Q

 

TABLE OF CONTENTS

 

    Page(s)
PART I: FINANCIAL INFORMATION  
     
Item 1. Financial Statements 1
  Condensed Consolidated Balance Sheets as of September 30, 2023 (Unaudited) and December 31, 2022 1
  Condensed Consolidated Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30, 2023 and 2022 3
  Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30, 2023 and 2022 4
  Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2023 and 2022 5
  Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) for the Three Months Ended September 30, 2023 and 2022 7
  Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2023 and 2022 8
  Notes to the Condensed Consolidated Financial Statements (Unaudited) 9
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 21
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 39
     
Item 4. Controls and Procedures 39
     
PART II: OTHER INFORMATION 40
     
Item 1. Legal Proceedings 40
     
Item 1A. Risk Factors 40
     
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities 40
     
Item 3. Defaults Upon Senior Securities 40
     
Item 4. Mine Safety Disclosures 40
     
Item 5. Other Information 40
     
Item 6. Exhibits 41
     
SIGNATURES 42

 

i
 

 

Cautionary Note Regarding Forward-Looking Statements

 

This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). 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), uncertainties and assumptions regarding the potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the U.S. and worldwide resulting from the COVID-19 pandemic, the Russian invasion of Ukraine and the unrest in the Middle East on our business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, any statements concerning proposed drug candidates, potential therapeutic benefits, 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, and any statements of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified using 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 inherent uncertainty in the drug development process, our ability to raise additional capital to fund our planned future operations, our ability to obtain or maintain FDA and foreign regulatory approvals for our drug candidates, potential impact of the outbreak, our ability to enroll patients in our clinical trials, risks relating to third parties conduct of our clinical trials, risks relating to government, private health insurers and other third-party payers coverage or reimbursement, risks relating to commercial potential of a drug candidate in development, changes in technologies for the treatment of cancer, impact of development of competitive drug candidates by others, risks relating to intellectual property, volatility in the market price of our common stock, potential inability to maintain compliance with The Nasdaq Marketplace Rules and the impact of adverse capital and credit market conditions. These and other risks, assumptions are described in Item 1A. Risk Factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in other documents that we file or furnish with the SEC. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. All forward-looking statements speak only as of the date they are made, and we do not intend to update any forward-looking statements, except as required by law or applicable regulations. 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,” “Imunon,” “we,” “us,” and “our” refer to Imunon, Inc., a Delaware corporation and its wholly owned subsidiaries.

 

Trademarks

 

The Company’s brand and product names contained in this document are trademarks, registered trademarks, or service marks of Imunon, Inc. 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

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

BALANCE SHEETS

 

  

September 30, 2023

  

December 31, 2022

 
   (Unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $12,884,199   $11,492,841 
Investment in debt securities - available for sale, at fair value   6,492,675    21,254,485 
Accrued interest receivable on investment securities   97,103    128,932 
Money market investments, restricted cash   -    1,500,000 
Advances and deposits on clinical programs and other current assets   2,251,475    2,403,433 
Total current assets   21,725,452    36,779,691 
           
Property and equipment (at cost, less accumulated depreciation and amortization)   823,551    548,301 
           
Other assets:          
Money market investments, restricted cash   -    4,500,000 
Deferred income tax asset   -    1,567,026 
Operating lease right-of-use assets, net   1,663,985    155,876 
Deposits and other assets   441,440    425,000 
Total other assets   2,105,425    6,647,902 
           
Total assets  $24,654,428   $43,975,894 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

1
 

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

BALANCE SHEETS

(Continued)

 

  

September 30, 2023

  

December 31, 2022

 
   (Unaudited)     
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable – trade  $1,826,762   $3,586,623 
Other accrued liabilities   3,019,135    4,794,936 
Note payable – current portion, net of deferred financing costs   -    1,424,774 
Operating lease liabilities - current portion   470,613    230,749 
Total current liabilities   5,316,510    10,037,082 
           
Notes payable – non-current portion, net of deferred financing costs   -    4,610,946 
Operating lease liabilities - non-current portion   1,266,176    - 
Total liabilities   6,582,686    14,648,028 
           
Commitments and contingencies   -    - 
           
Stockholders’ equity:          
           
Preferred stock - $0.01 par value (100,000 shares authorized, and no shares issued or outstanding
at September 30, 2023 and December 31, 2022)
   -    - 
           
Common stock - $0.01 par value (112,500,000 shares authorized; 9,367,929 and 7,436,219 shares issued at September 30, 2023 and December 31, 2022, respectively; 9,367,907 and 7,436,197 shares outstanding at September 30, 2023 and December 31, 2022, respectively)   93,679    74,362 
Additional paid-in capital   401,337,485    397,980,023 
Accumulated other comprehensive income   20,435    26,494 
Accumulated deficit   (383,294,669)   (368,667,825)
Total stockholders’ equity before treasury stock   18,156,930    29,413,054 
           
Treasury stock, at cost (22 shares at September 30, 2023 and December 31, 2022)   (85,188)   (85,188)
Total stockholders’ equity   18,071,742    29,327,866 
           
Total liabilities and stockholders’ equity  $24,654,428   $43,975,894 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

2
 

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

STATEMENTS OF OPERATIONS

(Unaudited)

 

   2023   2022   2023   2022 
  

For the Three Months Ended September 30,

  

For the Nine Months Ended September 30,

 
   2023   2022   2023   2022 
                 
Licensing revenue  $-   $125,000   $-   $375,000 
                     
Operating expenses:                    
Research and development   1,980,693    2,408,680    7,734,897    8,730,395 
General and administrative   1,923,375    3,890,886    7,327,906    9,639,419 
Total operating expenses   3,904,068    6,299,566    15,062,803    18,369,814 
                     
Loss from operations   (3,904,068)   (6,174,566)   (15,062,803)   (17,994,814)
                     
Other income (expense):                    
Investment income   427,454    153,301    962,197    205,760 
Interest expense   -    (127,025)   (197,080)   (4,878,306)
Loss on extinguishment of debt   -    -    (329,158)   - 
Other income   -    -    -    1,801 
Total other income (expense), net   427,454    26,276    435,959    (4,670,745)
                     
Net loss  $(3,476,614)  $(6,148,290)  $(14,626,844)  $(22,665,559)
                     
Net loss per common share                    
Basic and diluted  $(0.37)  $(0.87)  $(1.64)  $(3.42)
                     
Weighted average shares outstanding                    
Basic and diluted   9,376,872    7,098,741    8,926,114    6,621,925 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

3
 

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

 

   2023   2022   2023   2022 
  

For the Three Months Ended September 30,

  

For the Nine Months Ended September 30,

 
   2023   2022   2023   2022 
Other comprehensive loss                    
                     
Changes in:                    
Realized gains (losses) on debt securities recognized in investment income, net  $163,170   $10,369   $(26,913)  $34,303 
Unrealized (losses) gains on debt securities, net   (304,780)   34,241    20,854    (51,753)
                     
Change in realized and unrealized (losses) gains on available for sale securities, net   (141,610)   44,610    (6,059)   (17,450)
                     
Net loss   (3,476,614)   (6,148,290)   (14,626,844)   (22,665,559)
                     
Total comprehensive loss  $(3,618,224)  $(6,103,680)  $(14,632,903)  $(22,683,009)

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

4
 

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS

(Unaudited)

 

   2023   2022 
  

For the Nine Months Ended September 30,

 
   2023   2022 
Cash flows from operating activities:          
           
Net loss  $(14,626,844)  $(22,665,559)
           
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   176,509    117,371 
Amortization of right-of-use assets   402,940    396,181 
Recognition of deferred revenue   -    (375,000)
Realized and unrealized losses, net, on investment securities   (6,059)   (17,450)
Stock-based compensation   625,589    1,962,807 
Realization of deferred income tax asset   1,567,026    1,383,446 
Loss on extinguishment of debt   329,158    - 
Amortization of deferred finance charges and debt discount associated with notes payable   55,122    135,572 
Net changes in:          
Accrued interest receivable on investment securities   31,829    78,349 
Advances, deposits, and other current assets   135,517    (273,646)
Accounts payable and accrued liabilities   (3,940,670)   1,168,592 
Net cash used in operating activities   (15,249,883)   (18,089,337)
           
Cash flows from investing activities:          
Purchases of investment securities   (3,738,190)   (8,386,300)
Proceeds from sale and maturity of investment securities   18,500,000    27,775,000 
Purchases of property and equipment   (451,759)   (222,891)
Net cash provided by investing activities   14,310,051    19,165,809 
           
Cash flows from financing activities:          
Proceeds from redeemable convertible preferred stock offering   -    28,500,000 
Payment upon redemption of redeemable convertible preferred stock   -    (28,500,000)
Proceeds from sale of common stock equity, net of issuance costs   2,751,190    6,275,346 
Payoff of the SVB loan and accrued end-of-term fees   (6,420,000)   - 
Net cash (used in) provided by financing activities   (3,668,810)   6,275,346 
           
Net change in cash, cash equivalents and restricted cash   (4,608,642)   7,351,818 
Cash, cash equivalents and restricted cash at beginning of period   17,492,841    25,586,272 
Cash, cash equivalents and restricted cash at end of period  $12,884,199   $32,938,090 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

5
 

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

STATEMENTS OF CASH FLOWS (continued)

(Unaudited)

 

   For the Nine Months Ended September 30, 
   2023   2022 
         
Supplemental disclosures of cash flow information:          
Interest paid  $179,542   $4,742,734 
Recognition of right of use asset and liability  $1,911,049   $- 
           
Cash paid for amounts included in measurement of lease liabilities:          
Operating cash flows for lease payments  $510,779   $450,721 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

6
 

 

IMUNON, INC.

 

CONDENSED CONSOLIDATED

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

 

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

 

   Shares   Amount   Capital   Shares   Amount   (Loss)   Deficit   Total 
  

Common Stock

Outstanding

   Additional Paid-in   Treasury Stock  

Accum.

Other Compr.

Income

   Accumulated     
   Shares   Amount   Capital   Shares   Amount   (Loss)   Deficit   Total 
                                 
Balance at July 1, 2023-   9,252,003   $92,520   $401,163,818    22   $(85,188)  $162,045   $(379,818,055)  $21,515,140 
                                         
Net loss-   -    -    -    -    -    -    (3,476,614)   (3,476,614)
                                         
Sale of equity through equity financing facilities   62,904    629    77,103    -    -    -    -    77,732 
                                         
Issuance of common stock upon exercise of options   53,000    530    -    -    -    -    -    530 
                                         
Realized and unrealized gains (losses), net, on investment securities   -    -    -    -    -    (141,610)   -    (141,610)
                                         
Stock-based compensation expense   -    -    96,564    -    -    -    -    96,564 
Balance at September 30, 2023-   9,367,907   $93,679   $401,337,485    22      $(85,188)   $20,435   $(383,294,669)  $18,071,742 

 

   Common Stock Outstanding   Additional Paid-in   Treasury Stock   Accum. Other Compr. Income   Accumulated     
   Shares   Amount   Capital   Shares   Amount   (Loss)   Deficit   Total 
                                 
Balance at July 1, 2022-   7,098,741   $70,988   $396,413,587    22   $(85,188)  $(70,034)  $(349,286,860)  $47,042,493 
                                         
Net loss -  -    -    -    -    -    -    (6,148,290)   (6,148,290)
                                         
Fees incurred from registered direct offering   -    -    (64,023)   -    -    -    -    (64,023)
                                         
Realized and unrealized gains (losses), net, on investment securities   -    -    -    -    -    44,610    -    44,610 
                                         
Stock-based compensation expense   -    -    476,285    -    -    -    -    476,285 
Balance at September 30, 2022 -  7,098,741   $70,988   $396,825,849    22   $ (85,188 )  $(25,424)  $(355,435,150)  $41,351,075 

 

7
 

 


IMUNON, INC.

 

CONDENSED CONSOLIDATED

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited)

 

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022

 

  

Common Stock

Outstanding

   Additional Paid-in   Treasury Stock  

Accum.

Other Compr.

   Accumulated     
   Shares   Amount   Capital   Shares   Amount   (Loss)   Deficit   Total 
                                 
Balance at January 1, 2023-  7,436,219   $74,362   $397,980,023    22   $(85,188)  $26,494   $(368,667,825)  $29,327,866 
                                         
Net loss-  -    -    -    -    -    -    (14,626,844)   (14,626,844)
                                         
Sale of equity through equity financing facilities   1,878,488    18,785    2,731,873    -    -    -    -    2,750,658 
                                         
Issuance of common stock upon exercise of options   53,200    532         -    -    -    -    532 
                                         
Realized and unrealized gains (losses), net, on investment securities   -    -    -    -    -    (6,059)   -    (6,059)
                                         
Stock-based compensation expense   -    -    625,589    -    -    -    -    625,589 
Balance at September 30, 2023-  9,367,907   $93,679   $401,337,485    22   $(85,188)  $20,435   $(383,294,669)  $18,071,742 

 

   Shares   Amount   Shares   Amount   Capital   Shares   Amount       (Loss)   Deficit   Total 
   Series A & B
Preferred
  

Common Stock

Outstanding

   Additional Paid-in   Treasury Stock      

Accum.

Other Compr.

Income

   Accumulated     
   Shares   Amount   Shares   Amount   Capital   Shares   Amount       (Loss)   Deficit   Total 
                                             
Balance at January 1, 2022   -   $-    5,770,516   $57,705   $388,600,979    22        $(85,188)       $(7,974)  $(332,769,591)  $55,795,931 
                                                             
Net loss   -    -    -    -    -    -         -         -    (22,665,559)   (22,665,559)
                                                             
Effect of reverse stock split   -    -    (49)   -    -    -         -         -    -    - 
                                                             
Issuance of preferred stock upon financing   100,000    28,500,000    -    -    -    -         -         -    -    - 
                                                             
Redemption of preferred stock   (100,000)   (28,500,000)   -    -    -    -         -         -    -    - 
                                                             
Sale of equity through equity financing facilities, net of costs   -    -    1,328,274    13,283    6,262,063    -         -         -    -    6,275,346 
                                                             
Realized and unrealized gains (losses), net, on investment securities   -    -    -    -    -    -         -         (17,450)   -    (17,450)
                                                             
Stock-based compensation expense   -    -    -    -    1,962,807    -         -         -    -    1,962,807 
Balance at September 30, 2022   -   $-    7,098,741   $70,988   $396,825,849    22    $      (85,188    )   $(25,424)  $(355,435,150)  $41,351,075 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

8
 

 

IMUNON, INC.

 

NOTES TO THE CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS

(UNAUDITED)

 

SEPTEMBER 30, 2023

 

Note 1. Business Description

 

On September 19, 2022, Celsion Corporation announced a corporate name change to Imunon, Inc. (“Imunon” or the “Company”) reflecting the evolution of the Company’s business focus and its commitment to developing cutting-edge immunotherapies and next-generation vaccines to treat cancer and infectious diseases. The Company’s common stock continues to trade on the Nasdaq Stock Market under the ticker symbol “IMNN.”

 

Imunon is a fully integrated, clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. Imunon is developing its non-viral DNA technology across four modalities. The first modality, TheraPlas®, is developed for the coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases. The third modality, FixPlas®, concerns the application of Imunon’s DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas®, is in the discovery phase and will focus on the development of personalized cancer vaccines, or neoepitope cancer vaccines.

 

The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company is conducting IND-enabling preclinical studies for the development of a COVID-19 booster vaccine (IMNN-101) and a treatment for the LASSA virus (IMNN-102). The Company has also initiated preclinical work to develop a Trp2 tumor associated antigen cancer vaccine in melanoma (IMNN-201). Imunon will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions.

 

Note 2. Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements, which include the accounts of the Company and its wholly owned subsidiaries, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. All significant intercompany balances and transactions have been eliminated in consolidation. During the quarter ended September 30, 2023, there have been no changes to the Company’s accounting policies. Certain information and 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 nine months ended September 30, 2023 and 2022, 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 consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 30, 2023.

 

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 condensed consolidated 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 unaudited condensed consolidated financial statements and accompanying notes.

 

The Company has $19.5 million in cash and cash equivalents, short-term investments, and interest receivable to fund its operations. The Company also has approximately $1.8 million of future planned sales of the Company’s State of New Jersey net operating losses ($1.5 million in 2023 and $0.3 million in 2024). The Company believes it has sufficient capital resources to fund its operations for twelve months from the issuance of these condensed consolidated financial statements.

 

9
 

 

Note 3. New Accounting Pronouncements

 

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

 

Note 4. Restricted Cash

 

As a condition of the SVB Loan Facility entered into on June 18, 2021, as further discussed in Note 10, the Company was required at all times to maintain on deposit with SVB as cash collateral in a segregated money market bank account in the name of the Company, unrestricted and unencumbered cash (other than a lien in favor of SVB) in an amount of at least 100% of the aggregate outstanding amount of the SVB loan facility. SVB may restrict withdrawals or transfers by or on behalf of the Company that would violate this requirement. The loan was repaid in full during the quarter ended June 30, 2023, thus removing this requirement. The required reserve totaled $6.0 million as of December 31, 2022. This amount is presented in part as restricted cash in current and other non-current assets on the accompanying condensed consolidated balance sheets.

 

The following table reconciles cash and cash equivalents and restricted cash per the condensed consolidated balance sheets to the condensed consolidated statements of cash flows:

 

   September 30, 2023   December 31, 2022 
Cash and cash equivalents  $12,884,199   $11,492,841 
Money market investments, restricted cash   -    6,000,000 
Total  $12,884,199   $17,492,841 

 

Note 5. Net Loss per Common Share

 

Basic loss per share is calculated based upon the net loss available to common stockholders divided by the weighted average number of common shares outstanding during the period. Diluted loss 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.

 

The total number of shares of common stock issuable upon exercise of warrants, stock option grants and equity awards was 1,147,960 and 1,346,472 shares for the three-month and nine-month periods ended September 30, 2023 and 2022, respectively. For the three-month and nine-month periods ended September 30, 2023 and 2022, diluted loss per common share was the same as basic loss per common share as the other warrants and equity awards that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted loss per common share as their effect would have been anti-dilutive. The Company did not pay any dividends during the three-month and nine-month periods ended September 30, 2023 and 2022.

 

10
 

 

Note 6. Investment in Debt Securities-Available for Sale

 

Investments in debt securities available for sale with a fair value of $6,492,675 and $21,254,485 as of September 30, 2023 and December 31, 2022, respectively, consisted of U.S. Treasury securities and corporate debt securities. These investments are valued at estimated fair value, with unrealized gains and losses reported as a separate component of stockholders’ equity in accumulated other comprehensive income (loss).

 

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

 

   September 30, 2023   December 31, 2022 
   Cost   Fair Value   Cost   Fair Value 
Short-term investments                    
U.S. Treasury securities  $2,464,960   $2,498,335   $-   $- 
Corporate debt securities   4,007,280    3,994,340    21,227,991    21,254,485 
Total  $6,472,240   $6,492,675   $21,227,991   $21,254,485 

 

   September 30, 2023   December 31, 2022 
   Cost   Fair Value   Cost   Fair Value 
Short-term investment maturities                    
Within 3 months  $6,472,240   $6,492,675   $4,005,559   $3,994,590 
Between 3 and 12 months   -    -    17,222,432    17,259,895 
Total  $6,472,240   $6,492,675   $21,227,991   $21,254,485 

 

The following table shows the Company’s investment in debt securities available for sale gross unrealized gains (losses) and fair value by investment category and length of time that individual securities have been in a continuous unrealized loss position at September 30, 2023 and December 31, 2022. 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, 2023   December 31, 2022 
Available for sale securities (all unrealized holding gains and losses are less than 12 months at date of measurement)  Fair Value  

Unrealized Holding

Gains (Losses)

   Fair Value  

Unrealized Holding

Gains (Losses)

 
                 
Investments in debt securities with unrealized gains  $2,498,335   $33,375   $13,278,505   $43,508 
Investments in debt securities with unrealized gains (losses)   3,994,340    (12,940)   7,975,980    (17,014)
Total  $6,492,675   $20,435   $21,254,485   $26,494 

 

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

 

   2023   2022 
  

For the Three Months Ended September 30,

 
   2023   2022 
Interest and dividends accrued and paid  $264,284   $163,670 
Realized gains (losses)   163,170    (10,369)
Investment income, net  $427,454   $153,301 

 

   2023   2022 
  

For the Nine Months Ended September 30,

 
   2023   2022 
Interest and dividends accrued and paid  $935,284   $240,063 
Realized gains (losses)   26,913    (34,303)
Investment income, net  $962,197   $205,760 

 

11
 

 

Note 7. Fair Value Measurements

 

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

 

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

 

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

 

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

 

Cash and cash equivalents and accounts payable are reflected in the condensed consolidated balance sheets at their approximate estimated fair values primarily due to their short-term nature. The fair values of securities available for sale are determined by relying on the securities’ relationship to other benchmark quoted securities and classified its investments as Level 2 items in both 2023 and 2022. There were no transfers of assets or liabilities between Level 1 and Level 2 and no transfers in or out of Level 3 during the nine-month period ended September 30, 2023 or during the year ended December 31, 2022. The earnout milestone liability is valued using a risk-adjusted assessment of the probability of payment of each milestone, discounted to present value using an estimated time to achieve the milestone (see Note 13).

 

Assets and liabilities measured at fair value are summarized below.

 

   Total Fair Value   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, 2023                    
Corporate debt securities and U.S. Treasury obligations, available for sale  $6,492,675   $                    $                $6,492,675 
                     
Recurring items as of December 31, 2022                    
Corporate debt securities, available for sale  $21,254,485   $   $   $21,254,485 

 

Note 8. Intangible Assets

 

In June 2014, the Company completed the acquisition of substantially all of the assets of EGEN, Inc., an Alabama corporation (“EGEN”), which changed its company name to EGWU, Inc. after the closing of the acquisition (the “EGEN Acquisition”). The Company acquired EGEN’s rights, 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.

 

12
 

 

Acquired In-process Research and Development

 

Acquired in-process research and development (“IPR&D”) consists of EGEN’s drug technology platforms: TheraPlas and TheraSilence. The fair value of the IPR&D drug technology platforms was estimated to be $24.2 million as of the acquisition date. As of the closing of the acquisition, the IPR&D was considered indefinite lived intangible assets and will not be amortized. IPR&D is reviewed for impairment at least annually and whenever events or changes in circumstances indicate that the carrying value of the assets might not be recoverable. The Company’s IPR&D consisted of three core elements, its RNA delivery system, its glioblastoma multiforme cancer drug candidate and its ovarian cancer indication.

 

As of December 31, 2022, the Company assessed whether there were indicators of impairment for the Company’s IPR&D and determined that the IPR&D asset was impaired during that period. Due to the continuing deterioration of public capital markets in the biotech industry in 2022 and its impact on market capitalization rates in this sector, IPR&D was reviewed for impairment. Having conducted a quantitative analysis of its IPR&D assets, the Company concluded the IPR&D asset was impaired during the fourth quarter of 2022. As of December 31, 2022, the Company wrote off the $13.4 million carrying value of this asset, thereby recognizing a non-cash charge of $13.4 million in the fourth quarter of 2022.

 

Note 9. Accrued Liabilities

 

Other accrued liabilities at September 30, 2023 and December 31, 2022 include the following:

 

  

September 30, 2023

  

December 31, 2022

 
Amounts due to contract research organizations and other contractual agreements  $1,556,511   $2,196,711 
Accrued payroll and related benefits   1,416,024    2,139,927 
Accrued interest   -    37,583 
Accrued professional fees   26,600    215,402 
Other   20,000    205,313 
Total  $3,019,135   $4,794,936 

 

Note 10. Notes Payable

 

The SVB Loan Facility

 

On June 18, 2021, the Company entered into a $10 million loan facility (the “SVB Loan Facility”) with Silicon Valley Bank (“SVB”). The Company immediately used $6 million from the SVB Loan Facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation as further discussed below. Concurrently with this transaction, the Company used $6.0 million of other available funds to establish a restricted cash account which served as security for the SVB Loan Facility.

 

The SVB Loan Facility is in the form of money market secured indebtedness bearing interest at a calculated WSJ Prime-based variable rate. A final payment equal to 3% of the total $10 million commitment amount is due upon maturity or prepayment of the SVB Loan Facility. There was no facility commitment fee and no stock or warrants were issued to SVB. Payments under the loan agreement are interest only for the first 24 months after loan closing, followed by a 24-month amortization period of principal and interest through the scheduled maturity date.

 

In connection with the SVB Loan Facility, the Company incurred financing fees and expenses totaling $243,370 which are recorded and classified as debt discount and are being amortized as interest expense using the effective interest method over the life of the loan. Also, in connection with the SVB Loan Facility, the Company is required to pay an end-of-term fee equal to 3.0% of the original loan amount at time of maturity. Therefore, these amounts totaling $300,000 are being amortized as interest expense using the effective interest method over the life of the loan. During the three-month periods ended September 30, 2023 and 2022, the Company incurred interest expense of $0 and $82,083, respectively, and amortized $0 and $44,942, respectively, as interest expense for debt discounts and end-of-term fee in connection with the SVB Financing Facility. During the nine-month periods ended September 30, 2023 and 2022, the Company incurred interest expense of $141,958 and $191,167, respectively, and amortized $55,122 and $135,572, respectively, as interest expense for debt discounts and end-of-term fee in connection with the SVB Financing Facility.

 

13
 

 

On April 21, 2023, the Company repaid the outstanding principal balance, an early termination fee and the end-of-term charges in full satisfaction of the SVB Loan Facility. The following is a schedule of the amounts paid to SVB on April 21, 2023:

 

      
Principal balance at April 21, 2023  $6,000,000 
Early termination fee   120,000 
End-of-term charges   300,000 
Total  $6,420,000 

 

During the nine months ended September 30, 2023, the Company recorded a loss of $329,158 on the early termination of the SVB Loan Facility which represented the early termination fee and the end of the term fees, net of previously amortized interest expense totaling $334,212 on the date of its payoff.

 

Note 11. Stockholders’ Equity

 

On September 19, 2022, the Company announced a corporate name change to Imunon, Inc. The Company’s common stock will continue to trade on the Nasdaq Stock Market under the ticker symbol “IMNN” and its CUSIP number (15117N602) remained unchanged.

 

Reverse Stock Split

 

On February 28, 2022, the Company effected a 15-for-1 reverse stock split of its common stock which was made effective for trading purposes as of the commencement of trading on March 1, 2022. As of that date, each of the 15 shares of issued and outstanding common stock and equivalents was consolidated into one share of common stock. All shares have been restated to reflect the effects of the 15-for-1 reverse stock split. In addition, at the market open on March 1, 2022, the Company’s common stock started trading under a new CUSIP number 15117N602, although the Company’s ticker symbol, CLSN, remained unchanged.

 

The reverse stock split was previously approved by the Company’s stockholders at the 2022 Special Meeting held on February 24, 2022, and the Company subsequently filed a Certificate of Amendment to its Certificate of Incorporation to effect the stock consolidation.

 

Immediately prior to the reverse stock split, the Company had 86,557,736 shares of common stock outstanding which consolidated into 5,770,467 shares of the Company’s common stock. No fractional shares were issued in connection with the reverse stock split. Holders of fractional shares have been paid out in cash for the fractional portion with the Company’s overall exposure for such payouts consisting of a nominal amount. The amount of the Company’s outstanding convertible preferred stock was not affected by the reverse stock split. The number of outstanding options, stock awards and warrants were adjusted accordingly, with outstanding options and stock awards being reduced from approximately 6.6 million to approximately 0.4 million and outstanding warrants being reduced from approximately 2.5 million to approximately 0.2 million.

 

At the Market Offering Agreement

 

On May 25, 2022, the Company entered into an At the Market Offering Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which the Company may offer and sell, from time to time, through Wainwright, shares of the Company’s common stock having an aggregate offering price of up to $7,500,000. The Company intends to use the net proceeds from the offering, if any, for general corporate purposes, including research and development activities, capital expenditures and working capital. In 2022, the Company sold 336,075 shares of common stock for net proceeds of $503,798. During the first nine months of 2023, the Company sold 1,878,488 shares of common stock for net proceeds of $2,750,658.

 

14
 

 

Series A and Series B Convertible Redeemable Preferred Stock Offering

 

On January 10, 2022, the Company entered into a Securities Purchase Agreement (the “Preferred Stock Purchase Agreement”) with several institutional investors, pursuant to which the Company agreed to issue and sell, in concurrent registered direct offerings (the “Preferred Offerings”), (i) 50,000 shares of the Company’s Series A Convertible Redeemable Preferred Stock, par value $0.01 per share (the “Series A Preferred Stock”), and (ii) 50,000 shares of the Company’s Series B Convertible Redeemable Preferred Stock, par value $0.01 per share (the “Series B Preferred Stock” and together with the Series A Preferred Stock, the “Preferred Stock”), in each case at an offering price of $285 per share, representing a 5% original issue discount to the stated value of $300 per share, for gross proceeds of each Preferred Offering of $14.25 million, or approximately $28.50 million in the aggregate for the Preferred Offerings, before the deduction of the Placement Agent’s (as defined below) fee and offering expenses. The shares of Series A Preferred Stock had a stated value of $300 per share and were convertible, at a conversion price of $13.65 per share, into 1,098,901 shares of common stock (subject in certain circumstances to adjustments). The shares of Series B Preferred Stock had a stated value of $300 per share and were convertible, at a conversion price of $15.00 per share, into 1,000,000 shares of common stock (subject in certain circumstances to adjustments). The closing of the Preferred Offerings occurred on January 13, 2022.

 

The Company held a special meeting of stockholders to consider an amendment (the “Amendment”) to the Company’s Certificate of Incorporation, as amended, to effect a reverse stock split of the outstanding shares of common stock (“Common Stock”) by a ratio to be determined by the Board of Directors of the Company (the “Reverse Stock Split”). The investors of the Preferred Stock Purchase Agreement had agreed to not transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of the shares of the Preferred Stock until the Reverse Stock Split, to vote the shares of the Series A Preferred Stock purchased in the Preferred Offerings in favor of such Amendment and to vote the shares of the Series B Preferred Stock purchased in the Preferred Offerings in a manner that “mirrors” the proportions on which the shares of Common Stock (excluding any shares of Common Stock that are not voted) and Series A Preferred Stock are voted on the Reverse Stock Split and the Amendment.

 

Pursuant to the Preferred Stock Purchase Agreement, the Company filed two certificates of designation (the “Certificates of Designation”) with the Secretary of the State of Delaware designating the rights, preferences, and limitations of the shares of Preferred Stock. The Certificates of Designation provided, in particular, that the Preferred Stock had no voting rights, other than the right to vote as a class on certain specified matters, except that (i) each share of Series A Preferred Stock had the right to vote, on an as converted basis, on the Reverse Stock Split (together with the Company’s Common Stock and the Series B Preferred Stock as a single class), and (ii) each share of Series B Preferred Stock had the right to cast 3,000 votes per share of Series B Preferred Stock on the Reverse Stock Split.

 

The holders of Preferred Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of Common Stock. The Preferred Stock was convertible into shares of Common Stock at a rate of $13.65 per share for the Series A Preferred Stock and $15.00 per share for the Series B Preferred Stock, subject to adjustment. The Preferred Stock was convertible at the option of the holder at any time after the Company had received stockholder approval for the Reverse Stock Split and filed the requisite Amendment with the Delaware Secretary of State’s office to effectuate the Reverse Stock Split (the “Reverse Stock Split Date”), subject to beneficial ownership limitations set forth in the applicable Certificate of Designation. In addition, on or after the Reverse Stock Split Date, and subject to the satisfaction of certain conditions, the Company had the right to cause the holders of the Preferred Stock to convert their shares of Preferred Stock, subject to such beneficial ownership limitations.

 

Each holder of the Preferred Stock had the right to cause the Company to redeem all or part of their shares of the Preferred Stock from the earlier of receipt of stockholder approval of the Reverse Stock Split or of 90 days following the original issue date until 120 days following the original issue date, the “Redemption Date,” in cash at a redemption price equal to 105% of the stated value plus an amount equal to accumulated but unpaid dividends, if any, on such shares (whether or not earned or declared, but excluding interest on such dividends) up to, but excluding, the Redemption Date. In connection with the Preferred Offerings, the Company entered into a placement agent agreement (the “Placement Agent Agreement”) with AGP in which the Company paid $1,000,000 as a placement agent fee and $110,000 to reimburse AGP for certain expenses related to the Preferred Stock offering.

 

On March 3, 2022, the Company redeemed for cash at a price equal to 105% of the $300 stated value per share all of its 50,000 outstanding shares of Series A Preferred Stock and all of its 50,000 shares of Series B Preferred Stock. As a result, all shares of the Preferred Stock have been retired and are no longer outstanding and the Company’s only class of outstanding stock is its common stock.

 

15
 

 

The Series A Preferred Stock and Series B Preferred Stock were recorded as a liability on the condensed consolidated balance sheet during the first quarter of 2022 until the preferred shares were redeemed during the same quarter. The Company recognized $4,551,567 as interest expense for the preferred shares during the first quarter of 2022, which was composed of (a) $3,000,000 as the difference between the redemption price for the preferred shares and the net proceeds received from the issuance of the preferred shares, (b) $1,110,000 paid to AGP as a placement agent fee and reimbursement for certain expenses, and (c) $441,567 in legal fees recognized in the first quarter that were attributed to the preferred shares.

 

April 2022 Registered Direct Offering

 

On April 6, 2022, the Company entered into a Securities Purchase Agreement (the “April 2022 Purchase Agreement”) with several institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “April 2022 Offering”), an aggregate of 1,328,274 shares of the Company’s common stock at an offering price of $5.27 per share for gross proceeds of $7.0 million before the deduction of the April 2022 Placement Agent (as defined below) fees and offering expenses. The closing of the April 2022 Offering occurred on April 8, 2022.

 

In connection with the April 2022 Offering, the Company entered into a placement agent agreement with A.G.P./Alliance Global Partners (the “April 2022 Placement Agent”) pursuant to which the Company agreed to pay the April 2022 Placement Agent a cash fee equal to 6.5% of the aggregate gross proceeds raised from the sale of the securities sold in the April 2022 Offering and reimburse the April 2022 Placement Agent for certain of their expenses in an amount not to exceed $50,000.

 

Note 12. Stock-Based Compensation

 

The Company has long-term compensation plans that permit the granting of equity-based awards in the form of stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, and performance awards.

 

At the 2018 Annual Stockholders Meeting of the Company held on May 15, 2018, stockholders approved the 2018 Stock Incentive Plan (the “2018 Plan”). The 2018 Plan, as adopted, permits the granting of 180,000 shares of common stock as equity awards in the form of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, other stock awards, performance awards, or in any combination of the foregoing. At the 2019 Annual Stockholders Meeting of the Company held on May 14, 2019, stockholders approved an amendment to the 2018 Plan whereby the Company increased the number of common stock shares available by 80,000 to a total of 260,000 under the 2018 Plan, as amended. At the 2020 Annual Stockholders Meeting of the Company held on June 15, 2020, stockholders approved an amendment to the 2018 Plan, as previously amended, whereby the Company increased the number of shares of common stock available by 166,667 to a total of 426,667 under the 2018 Plan, as amended. At the 2021 Annual Stockholders Meeting of the Company held on June 10, 2021, stockholders approved an amendment to the 2018 Plan, as previously amended, whereby the Company increased the number of shares of common stock available by 513,333 to a total of 940,000 under the 2018 Plan, as amended. At the 2023 Annual Stockholders Meeting of the Company held on June 14, 2023, stockholders approved an amendment to the 2018 Plan, as previously amended, whereby the Company increased the number of shares of common stock available by 1,030,000 to a total of 1,970,000 under the 2018 Plan, as amended. Prior to the adoption of the 2018 Plan, the Company had maintained the 2007 Stock Incentive Plan (the “2007 Plan”).

 

The Company has issued stock awards to employees and directors in the form of stock options and restricted stock. Options are generally granted with strike prices equal to the fair market value of a share of common stock on the date of grant. Incentive stock options may be granted to purchase shares of common stock at a price not less than 100% of the fair market value of the underlying shares on the date of grant, provided that the exercise price of any incentive stock option granted to an eligible employee owning more than 10% of the outstanding stock of the Company must be at least 110% of such fair market value on the date of grant. Only officers and key employees may receive incentive stock options.

 

Option and restricted stock awards vest upon terms determined by the Compensation Committee of the Board of Directors and are subject to accelerated vesting in the event of a change of control or certain terminations of employment. The Company issues new shares to satisfy its obligations from the exercise of options or the grant of restricted stock awards.

 

16
 

 

On July 19, 2022, September 27, 2022, December 13, 2022, March 17, 2023 and June 26, 2023, the Compensation Committee of the Board of Directors approved the grant of (i) inducement stock options (the “Inducement Option Grants”) to purchase a total of 177,000 shares, 8,501 shares, 19,000 shares, 5,230 shares and 5,000 shares of common stock, respectively, and (ii) inducement restricted stock awards (the “Inducement Stock Grants”) totaling 63,000 shares, 2,250 shares, 4,000 shares, 1,100 shares and 1,000 shares of common stock, respectively, to eleven employees. Each Inducement Option Grant has an exercise price per share equal to $1.95, $1.65, $1.40, $1.32, and $1.28 which represents the closing price of the Company’s common stock as reported by Nasdaq on July 19, 2022, September 27, 2022, December 13, 2022, March 17, 2023, and June 26, 2023, respectively. Each Inducement Option Grant vests over three to four years, with one-third or one-fourth vesting on the one-year anniversary of the employee’s first day of employment with the Company and one-third or one-fourth vesting on the second thru fourth anniversaries thereafter, subject to the new employee’s continued service relationship with the Company on each such date. Each Inducement Option Grant has a ten-year term and is subject to the terms and conditions of the applicable stock option agreement. Each of Inducement Stock Grant vested on the one-year anniversary of the employee’s first day of employment with the Company is subject to the new employee’s continued service relationship with the Company through such date and is subject to the terms and conditions of the applicable restricted stock agreement. As of September 30, 2023, there were a total of 214,751 shares of the Company’s common stock subject to outstanding inducement awards.

 

As of September 30, 2023, there were a total of 1,975,073 shares of the Company’s common stock reserved for issuance under the 2018 Plan, which were comprised of 802,363 shares of the Company’s common stock subject to equity awards previously granted under the 2018 Plan and 2007 Plan and 1,172,710 shares of the Company’s common stock available for future issuance under the 2018 Plan.

 

A summary of stock option awards and restricted stock grants, inclusive of awards granted under the 2018 Stock Plan and Inducement Option Grants for the nine months ended September 30, 2023 is presented below.

 

   Stock Options   Restricted Stock Awards  

Weighted

Average

 
  

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 January 1, 2023   760,220   $4.55    69,650   $1.92      
                          
Equity awards granted   335,000   $1.32    2,100   $1.30      
                          
Equity awards vested and issued   -    -    (53,200)   1.96      
                          
Equity awards terminated   (125,672)  $8.99    (200)  $4.60      
                          
Equity awards outstanding at September 30, 2023   969,548   $2.86    18,350   $1.70    8.9 
                          
Aggregate intrinsic value of outstanding equity awards at September 30, 2023  $-        $-           
                          
Equity awards exercisable at September 30, 2023   400,879   $4.03              8.7 
                          
Aggregate intrinsic value of equity awards exercisable at September 30, 2023  $-                     

 

17
 

 

Total compensation cost related to stock options and restricted stock awards amounted to approximately $0.6 million and $2.0 million for the nine-month periods ended September 30, 2023 and 2022, respectively. Of these amounts, $0.2 million and $0.7 million were charged to research and development during the nine-month periods ended September 30, 2023 and 2022, respectively, and $0.4 million and $1.3 million were charged to general and administrative expenses during the nine-month periods ended September 30, 2023 and 2022, respectively.

 

As of September 30, 2023, there was $0.4 million of total unrecognized compensation cost related to non-vested stock-based compensation arrangements. That cost is expected to be recognized over a period of 3 to 4 years. The weighted average grant date fair values of the stock options granted were $2.03 and $4.16 during the nine-month periods ended September 30, 2023 and 2022, respectively.

 

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 the Company’s stock options. The model is also sensitive to changes in assumptions, which can materially affect the fair value estimate. The Company used the following assumptions for determining the fair value of options granted under the Black-Scholes option pricing model:

 

  

For the Nine Months Ended September 30,

 
   2023   2022 
Risk-free interest rate   3.72%   1.74 to 4.14%
Expected volatility   107.03 to 113.64%   107.6 to 113.95%
Expected life (in years)   9.0 to 10.0   7.5 to 9.0
Expected dividend yield   -%   -%

 

Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price. The risk-free interest rate is derived from values assigned to U.S. Treasury bonds with terms that approximate the expected option lives in effect at the time of grant.

 

Note 13. Earn-Out Milestone Liability

 

The total aggregate purchase price for the EGEN Acquisition (see Note 8) included potential future earn-out payments contingent upon achievement of certain milestones. The difference between the aggregate $30.4 million in future earn-out payments and the $13.9 million included in the fair value of the acquisition consideration at June 20, 2014 was based on the Company’s risk-adjusted assessment of each milestone (10% to 67%) and utilizing a discount rate based on the estimated time to achieve the milestone (1.5 to 2.5 years). The earn-out milestone liability is fair valued at the end of each quarter and any change in their value will be recognized in the condensed consolidated financial statements.

 

On March 28, 2019, the Company and EGWU, Inc. entered into an amendment to its purchase agreement (“Amended Asset Purchase Agreement”), whereby payment of the earnout milestone liability related to the Ovarian Cancer Indication of $12.4 million had been modified. The Company has the option to make the payment as follows:

 

a) $7.0 million in cash within 10 business days of achieving the milestone; or
b) $12.4 million in cash, common stock of the Company, or a combination of either, within one year of achieving the milestone.

 

At December 31, 2022, the Company wrote off the carrying value of the earn-out milestone liability as a result of the requirements not being achieved and recognized a non-cash gain of $5.4 million during 2022 as a result of the change in the fair value of the earn-out milestone liability.

 

18
 

 

Note 14. Warrants

 

The following is a summary of all warrant activity for the nine-month period ended September 30, 2023:

 

Warrants 

Number of
Warrants

Issued

  

Weighted

Average

Exercise Price

 
         
Warrants outstanding at December 31, 2022   168,519   $19.78 
           
Warrants expired during the nine months ended September 30, 2023   (8,459)  $37.29 
           
Warrants outstanding at September 30, 2023   160,060   $18.86 
           
Aggregate intrinsic value of outstanding warrants at September 30, 2023  $-      
           
Weighted average remaining contractual terms at September 30, 2023   2.4 years      

 

Note 15. Leases

 

In August 2023, the Company renewed its Lawrenceville office lease for a 24-month agreement for 9,850 square feet with monthly rent payments of approximately $22,983 to $23,394.

 

In January 2023, the Company renewed its Huntsville facility lease for a 60-month lease agreement for 11,420 square feet with monthly rent payments of approximately $28,550 to $30,903.

 

The following is a table of the lease payments and maturity of the Company’s operating lease liabilities as of September 30, 2023:

 

      
2023  $154,600 
2024   626,323 
2025   543,009 
2026   362,976 
2027   370,236 
Thereafter   30,903 
Subtotal future lease payments   2,088,047 
Less imputed interest   (351,258)
Total lease liabilities  $1,736,789 
      
Weighted average remaining life   3.72 
      
Weighted average discount rate   9.98%

 

For the three-month and nine-month periods ended September 30, 2023, operating lease expense was $163,201 and $487,923, respectively, and cash paid for operating leases included in operating cash flows was $162,808 and $489,993, respectively.

 

For the three-month and nine-month periods ended September 30, 2022, operating lease expense was $146,936 and $440,808, respectively, and cash paid for operating leases included in operating cash flows was $150,774 and $450,721, respectively.

 

19
 

 

Note 16. Technology Development and Licensing Agreements

 

On May 7, 2012, the Company entered into a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (“Hisun”) for the production of ThermoDox® in the China territory. In accordance with the terms of the agreement, Hisun will be responsible for providing all of the technical and regulatory support services, including the costs of all technical transfer, registration and bioequivalence studies, technical transfer costs, Imunon consultative support costs and the purchase of any necessary equipment and additional facility costs necessary to support capacity requirements for the manufacture of ThermoDox®. Imunon 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 meet 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 Imunon around the regulatory approval activities for ThermoDox® with the China State Food and Drug Administration.

 

On January 18, 2013, the Company entered into a technology development contract with Hisun, pursuant to which Hisun paid it a non-refundable research and development fee of $5 million to support development of ThermoDox® in mainland China, Hong Kong and Macau (the China territory). Following the Company’s announcement on January 31, 2013 that the HEAT study failed to meet its primary endpoint, Imunon 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 HCC 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 was 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. As of December 31, 2022, this contract has been fully amortized and recognized as revenue.

 

Note 17. Commitments and Contingencies

 

On October 29, 2020, a putative securities class action was filed against the Company and certain of its officers and directors (the “Spar Individual Defendants”) in the U.S. District Court for the District of New Jersey, captioned Spar v. Celsion Corporation, et al., Case No. 1:20-cv-15228 (“the Spar Action”). The plaintiff alleged that the Company and Individual Defendants made false and misleading statements regarding one of the Company’s drug candidates, ThermoDox®, and brings claims for damages under Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder against all Defendants, and under Section 20(a) of the Exchange Act of 1934 against the Individual Defendants. At this stage of the case neither the likelihood that a loss, if any, will be realized, nor an estimate of possible loss or range of loss, if any, can be determined. On February 6, 2023, the U.S. District Court granted a Motion to Dismiss filed by the Company and Spar Individual Defendants and granted Plaintiff leave to file an amended complaint within 30 days. Plaintiff did not file an amended complaint within the 30-day deadline. In September 2023, the U.S. District Court Issued an Order for Dismissal without prejudice.

 

In February 2021, a derivative shareholder lawsuit was filed against the Company, as the nominal defendant, and certain of its directors and officers as defendants in the U.S. District Court for the District of New Jersey, captioned Fidler v. Michael H. Tardugno, et al., Case No. 3:21-cv-02662. The plaintiff alleges breach of fiduciary duty and other claims arising out of alleged statements made by certain of the Company’s directors and/or officers regarding ThermoDox®. The Company believes it has meritorious defenses to these claims and intends to vigorously contest this suit. At this stage of the case neither the likelihood that a loss, if any, will be realized, nor an estimate of possible loss or range of loss, if any, can be determined. The U.S. District Court has stayed the action pending an appeal in the Spar Action or until the time to appear has run in the Spar Action without any decision being made.

 

Note 18. Related Party Transaction

 

On November 16, 2022, the Company entered into a Convertible Note Purchase Agreement with Transomic Technologies, Inc. (“Transomic”) whereby the Company purchased $375,000 of convertible notes secured by certain assets held by Transomic and warrants. The Notes, which are included in deposits and other assets, bear interest at 5% per annum, with interest and principal due on December 31, 2026. The Notes are classified as available for sale. The warrants are exercisable upon closing and expire 36 months from the date of issuance or November 22, 2025. As a result of Mr. Tardugno’s appointment to the Board of Transomic, the Company is disclosing the notes receivable as a related party transaction.

 

Note 19. Subsequent Events

 

The Company has evaluated its subsequent events from September 30, 2023, through the date these condensed consolidated financial statements were issued.

 

20
 

 

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The following discussion and analysis of our financial condition and results of operations This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those discussed in forward-looking statements. Factors that might cause a difference include, but are not limited to, those discussed above under “Cautionary Note Regarding Forward-Looking Statements,” and in Item 1A. Risk factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.

 

Strategic and Clinical Overview

 

On September 19, 2022, Celsion Corporation announced a corporate name change to Imunon, Inc., reflecting the evolution of the Company’s business focus and its commitment to developing cutting-edge immunotherapies and next-generation vaccines to treat cancer and infectious diseases. The Company’s common stock continues to trade on the Nasdaq Stock Market under the ticker symbol “IMNN.”

 

Imunon, Inc. (“Imunon” and the “Company”) is a fully integrated, clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. Imunon is developing its non-viral DNA technology across four modalities. The first modality, TheraPlas®, is developed for the coding of proteins and cytokines in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the coding of viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases. The third modality, FixPlas®, concerns the application of our DNA technology to produce universal cancer vaccines, also called tumor associated antigen cancer vaccines. The fourth modality, IndiPlas®, is in the discovery phase and will focus on the development of personalized cancer vaccines, or neoepitope cancer vaccines.

 

The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company is conducting IND-enabling preclinical studies for the development of a COVID-19 booster vaccine (IMNN-101) and a treatment for the LASSA virus (IMNN-102). The Company has also initiated preclinical work to develop a Trp2 tumor associated antigen cancer vaccine in melanoma (IMNN-201). We will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions.

 

Technology Platform

 

Imunon’s technology platform is optimized for the delivery of DNA and mRNA therapeutics via synthetic non-viral carriers and is capable of providing cell transfection for double-stranded DNA plasmids and large therapeutic RNA segments such as mRNA. There are two components to the system, a backbone with plasmid DNA or mRNA payload encoding therapeutic proteins, or pathogen antigens or tumor associated antigens or cancer neoantigens and a delivery system. The delivery system is designed to protect the DNA/mRNA from degradation and promote trafficking into cells and through intracellular compartments. We designed the delivery system by chemically modifying the low molecular weight polymer to improve its gene transfer activity without increasing toxicity. We believe that our non-viral DNA technology may be a viable alternative to current approaches to gene delivery due to several distinguishing characteristics, including enhanced molecular versatility that allows for complex modifications to potentially improve activity and safety.

 

The biocompatibility of these polymers reduces the risk of adverse immune response, thus allowing for repeated administration. Compared to naked DNA or cationic lipids, our delivery systems are generally safer, more efficient, and cost effective. We believe that these advantages place Imunon in a position to capitalize on this technology platform.

 

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THERAPLAS MODALITY: IMNN-001 DEVELOPMENT PROGRAM

 

Ovarian Cancer Overview

 

Ovarian cancer is the most lethal of gynecological malignancies among women with an overall five-year survival rate of 45%. This poor outcome is due in part to the lack of effective prevention and early detection strategies. There were approximately 20,000 new cases of ovarian cancer in the U.S. in 2021 with an estimated 13,000 deaths. Mortality rates for ovarian cancer declined very little in the last forty years due to the unavailability of detection tests and improved treatments. Most women with ovarian cancer are not diagnosed until Stages III or IV, when the disease has spread outside the pelvis to the abdomen and areas beyond, causing swelling and pain. The five-year survival rates for Stages III and IV are 39 percent and 17 percent, respectively. Firstline chemotherapy regimens are typically platinum-based combination therapies. Although this first line of treatment has an approximate 80 percent response rate, 55 to 75 percent of women will develop recurrent ovarian cancer within two years and ultimately will not respond to platinum therapy. Patients whose cancer recurs or progresses after initially responding to surgery and first-line chemotherapy have been divided into one of the two groups based on the time from completion of platinum therapy to disease recurrence or progression. This time period is referred to as platinum-free interval. The platinum-sensitive group has a platinum-free interval of longer than six months. This group generally responds to additional treatment with platinum-based therapies. The platinum-resistant group has a platinum-free interval of shorter than six months and is resistant to additional platinum-based treatments. Pegylated liposomal doxorubicin, topotecan, and Avastin are the only approved second-line therapies for platinum-resistant ovarian cancer. The overall response rate for these therapies is 10 to 20 percent with median overall survival (“OS”) of eleven to twelve months. Additionally, 10% to 15% of ovarian cancer cases nationwide are a result of germline or somatic BRCA mutations. With cognizance of tumor genetics, practice has shifted to include targeted agents in ovarian cancer treatment.

 

PARP enzymes are responsible for detecting and repairing single-stranded and double-stranded DNA breaks during cell replication. BRCA1/2 mutations hinder the homologous recombination repair pathway, and tumor cells utilize PARP enzymes to repair DNA. For this reason, these tumors are particularly sensitive to the mechanism of PARP inhibitors. PARP inhibitors have expanded treatment options in ovarian cancer, but few treatment options are left for women who are not eligible to receive PARP inhibitors.

 

Immunotherapy is an attractive novel approach for the treatment of ovarian cancer particularly since ovarian cancers are considered immunogenic tumors. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The precedence for a therapeutic role of IL-12 in ovarian cancer is based on epidemiologic and preclinical data.

 

IMNN-001 Immunotherapy

 

IMNN-001 is a DNA-based immunotherapeutic drug candidate for the localized treatment of ovarian cancer by intraperitoneally administering an Interleukin-12 (“IL-12”) plasmid formulated with our proprietary TheraPlas delivery system. In this DNA-based approach, the immunotherapy is combined with a standard chemotherapy drug, which can potentially achieve better clinical outcomes than with chemotherapy alone. We believe that increases in IL12 concentrations at tumor sites for several days after a single administration could create a potent immune environment against tumor activity and that a direct killing of the tumor with concomitant use of cytotoxic chemotherapy could result in a more robust and durable antitumor response than chemotherapy alone. We believe the rationale for local therapy with IMNN-001 is based on the following:

 

  Loco-regional production of the potent cytokine IL-12 avoids toxicities and poor pharmacokinetics associated with systemic delivery of recombinant IL-12;
     
  Persistent local delivery of IL-12 lasts up to one week and dosing can be repeated; and
     
  Local therapy is ideal for long-term maintenance therapy.

 

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OVATION I Study. In February 2015, we announced that the U.S. Food and Drug Administration (“FDA”) accepted, without objection, the Phase I dose-escalation clinical trial of IMNN-001 in combination with the standard of care in neoadjuvant ovarian cancer (the “OVATION I Study”). On September 30, 2015, we announced enrollment of the first patient in the OVATION I Study. The OVATION I Study was designed to:

 

  (i) identify a safe, tolerable, and therapeutically active dose of IMNN-001 by recruiting and maximizing an immune response;
     
  (ii) enroll three to six patients per dose level and evaluate safety and efficacy; and
     
  (iii) attempt to define an optimal dose for a follow-on Phase I/II study.

 

In addition, the OVATION I Study established a unique opportunity to assess how cytokine-based compounds such as IMNN-001, directly affect ovarian cancer cells and the tumor microenvironment in newly diagnosed ovarian cancer patients. The study was designed to characterize the nature of the immune response triggered by IMNN-001 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 immune-suppressive cytokines associated with tumor suppression and growth, respectively; and
     
  Expression profile of a comprehensive panel of immune related genes in pre-treatment and IMNN-001-treated tumor tissue.

 

We initiated the OVATION I Study at four clinical sites at the University of Alabama at Birmingham, Oklahoma University Medical Center, Washington University in St. Louis, and the Medical College of Wisconsin. During 2016 and 2017, we announced data from the first fourteen patients in the OVATION I Study. On October 3, 2017, we announced final translational research and clinical data from the OVATION I Study.

 

Key translational research findings from all evaluable patients are consistent with the earlier reports from partial analysis of the data and are summarized below:

 

  The intraperitoneal treatment of IMNN-001 in conjunction with NACT resulted in dose dependent increases in IL-12 and Interferon-gamma (IFNγ) levels that were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic circulation. These and other post-treatment changes including decreases in VEGF levels in peritoneal fluid are consistent with an IL-12 based immune mechanism;
     
  Consistent with the previous partial reports, the effects observed in the IHC analysis were pronounced decreases in the density of immunosuppressive T-cell signals (Foxp3, PD-1, PDL-1, IDO-1) and increases in CD8+ cells in the tumor microenvironment;
     
  The ratio of CD8+ cells to immunosuppressive cells was increased in approximately 75% of patients suggesting an overall shift in the tumor microenvironment from immunosuppressive to pro-immune stimulatory following treatment with IMNN-001. An increase in CD8+ to immunosuppressive T-cell populations is a leading indicator and believed to be a good predictor of improved OS; and
     
  Analysis of peritoneal fluid by cell sorting, not reported before, shows a treatment-related decrease in the percentage of immunosuppressive T-cell (Foxp3+), which is consistent with the reduction of Foxp3+ T-cells in the primary tumor tissue, and a shift in tumor naïve CD8+ cell population to more efficient tumor killing memory effector CD8+ cells.

 

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The Company also reported encouraging clinical data from the first fourteen patients who completed treatment in the OVATION I Study. IMNN-001 plus standard chemotherapy produced no dose limiting toxicities and positive dose dependent efficacy signals which correlate well with positive surgical outcomes as summarized below:

 

  Of the fourteen patients treated in the entire study, two patients demonstrated a complete response, ten patients demonstrated a partial response and two patients demonstrated stable disease, as measured by RECIST criteria. This translates to a 100% disease control rate and an 86% objective response rate (“ORR”). Of the five patients treated in the highest dose cohort, there was a 100% ORR with one complete response and four partial responses;
     
  Fourteen patients had successful resections of their tumors, with nine patients (64%) having a complete tumor resection (“R0”), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Seven out of eight (88%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five patients treated at the highest dose cohort experienced a R0 surgical resection; and
     
  All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells.

 

On March 26, 2020, the Company announced with Medidata, a Dassault Systèmes company, that examining matched patient data provided by Medidata in a synthetic control arm (“SCA”) with results from the Company’s completed Phase Ib dose-escalating OVATION I Study showed positive results in progression-free survival (“PFS”). The hazard ratio (“HR”) was 0.53 in the ITT group, showing strong signals of efficacy. The Company believes these data may warrant consideration of strategies to accelerate the clinical development program for IMNN-001 in newly diagnosed, advanced ovarian cancer patients by the FDA. In its March 2019 discussion with the Company, the FDA noted that preliminary findings from the Phase Ib OVATION I Study were exciting but lacked a control group to evaluate IMNN-001’s independent impact on impressive tumor response, surgical results and PFS. The FDA encouraged the Company to continue its IMNN-001 development program and consult with FDA with new findings that may have a bearing on designations such as Fast Track and Breakthrough Therapy.

 

SCAs have the potential to revolutionize clinical trials in certain oncology indications and some other diseases where randomized control is not ethical or practical. SCAs are formed by carefully selecting control patients from historical clinical trials to match the demographic and disease characteristics of the patients treated with the new investigational product. SCAs have been shown to mimic the results of traditional randomized controls so that the treatment effects of an investigational product can be visible by comparison to the SCA. SCAs can help advance the scientific validity of single arm trials, and in certain indications, reduce time and cost, and expose fewer patients to placebos or existing standard-of-care treatments that might not be effective for them.

 

On July 29, 2021, the Company announced final progression free survival (“PFS”) results from the OVATION I Study published in the Journal of Clinical Cancer Research. Median PFS in patients treated per protocol (n=14) was 21 months and was 18.4 months for the intent-to-treat (“ITT”) population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, and two patients who did not receive full NAC and IMNN001 cycles. Under the current standard of care, in women with Stage III/IV ovarian cancer undergoing NAC, their disease progresses within about 12 months on average. The results from the OVATION I Study support continued evaluation of IMNN-001 based on promising tumor response, as reported in the PFS data, and the ability for surgeons to completely remove visible tumors at interval debulking surgery. IMNN-001 was well tolerated, and no dose-limiting toxicities were detected. Intraperitoneal administration of IMNN-001 was feasible with broad patient acceptance.

 

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OVATION 2 Study. The Company held an Advisory Board Meeting on September 27, 2017 with the clinical investigators and scientific experts including those from Roswell Park Cancer Institute, Vanderbilt University Medical School, and M.D. Anderson Cancer Center to review and finalize clinical, translational research and safety data from the OVATION I Study to determine the next steps forward for our IMNN-001 immunotherapy program. On November 13, 2017, the Company filed its Phase I/II clinical trial protocol with the FDA for IMNN-001 for the localized treatment of ovarian cancer. The protocol is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of IMNN-001 while maximizing an immune response. The Phase I portion of the study will be followed by a continuation at the selected dose in approximately 110 patients randomized Phase II study.

 

In the OVATION 2 Study, patients in the IMNN-001 treatment arm will receive IMNN-001 plus chemotherapy pre- and post-interval debulking surgery (“IDS”). The OVATION 2 Study will include up to 110 patients with Stage III/IV ovarian cancer, with 12 to 15 patients in the Phase I portion and up to 95 patients in Phase II. The study is powered to show a 33% improvement in the primary endpoint, PFS, when comparing IMNN-001 with neoadjuvant + adjuvant chemotherapy versus neoadjuvant + adjuvant chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.

 

In March 2020, the Company announced encouraging initial clinical data from the first 15 patients enrolled in the Phase I portion of the OVATION 2 Study for patients newly diagnosed with Stage III and IV ovarian cancer. The OVATION 2 Study combines IMNN-001, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (“NACT”). Following NACT, patients undergo interval debulking surgery (IDS), followed by three additional cycles of chemotherapy.

 

IMNN-001 plus standard NACT produced positive dose-dependent efficacy results, with no dose-limiting toxicities, which correlates well with successful surgical outcomes as summarized below:

 

  Of the fifteen patients treated in the Phase I portion of the OVATION 2 Study, nine patients were treated with IMNN-001 at a dose of 100 mg/m² plus NACT and six patients were treated with NACT only. All fifteen patients had successful resections of their tumors, with eight out of nine patients (88%) in the IMNN-001 treatment arm having an R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed. Only three out of six patients (50%) in the NACT only treatment arm had a R0 resection.
     
  When combining these results with the surgical resection rates observed in the Company’s OVATION 1 Study, a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding IMNN-001 to the current standard of care NACT:

 

      % of Patients R0
Resections
 
0, 36, 47 mg/m² of IMNN-001 plus NACT  N =12   42%
61, 79, 100 mg/m² of IMNN-001 plus NACT  N = 17   82%

 

  The ORR as measured by Response Evaluation Criteria in Solid Tumors (“RECIST”) criteria for the 0, 36, 47 mg/m² dose IMNN-001 patients were comparable, as expected, to the higher (61, 79, 100 mg/m²) dose IMNN-001 patients, with both groups demonstrating an approximate 80% ORR.

 

On March 23, 2020, the Company announced that the European Medicines Agency (the “EMA”) Committee for Orphan Medicinal Products (“COMP”) has recommended that IMNN-001 be designated as an orphan medicinal product for the treatment of ovarian cancer. IMNN-001 is an IL-12 DNA plasmid vector encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IMNN-001 previously received orphan designation from the FDA.

 

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In February 2021, the Company announced that it has received Fast Track designation from the FDA for IMNN-001, its DNA-mediated IL-12 immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer and also provided an update on the OVATION 2 Study. The Company reported that approximately one-third, or 34 patients, of the anticipated 110 patients had been enrolled into the OVATION 2 Study, of which 20 are in the treatment arm and 14 are in the control. Of the 34 patients enrolled in the trial, 27 patients have had their interval debulking surgery with the following results:

 

  80% of patients treated with IMNN-001 had a R0 resection, which indicates a microscopically margin-negative complete resection in which no gross or microscopic tumor remains in the tumor bed.
     
  58% of patients in the control arm had an R0 resection.
     
  This interim data represents a 38% improvement in R0 resection rates for IMNN-001 patients compared with control arm patients and is consistent with the reported improvement in resection scores noted in the encouraging Phase I OVATION I Study, the manuscript of which has been submitted for peer review publication.

 

In June 2022, the Company announced that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in the control arm) randomized in the OVATION 2 Study, the Data Safety Monitoring Board (“DSMB”) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate IMNN-001 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported. Interim clinical data from patients who have undergone interval debulking surgery showed that the IMNN-001 treatment arm is continuing to show improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores over the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.

 

In September 2022, the Company announced that its Phase I/II OVATION 2 Study with IMNN-001 in advanced ovarian cancer has completed enrollment with 110 patients.

 

In April 2023, the Company presented a poster at the American Association for Cancer Research Annual Meeting Demonstrating Preclinical Immune Response of IMNN-001. The findings from a mouse model of peritoneally disseminated ovarian cancer suggest biweekly dosing regimen for further evaluation in human clinical studies. This research in mice will underpin the dosing frequency being investigated in our upcoming Phase 1/2 combination study with IMNN-001 and bevacizumab following neoadjuvant chemotherapy in advanced ovarian cancer.

 

In September 2023, the Company announced interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in its Phase 1/2 OVATION 2 Study. Interim clinical data from the intent-to-treat (ITT) population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the required value. Preliminary OS data follows a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm.

 

Subgroup analyses show patients treated with a PARP inhibitor (PARPi) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001 compared with patients treated with NACT only. This was not a pre-specified subgroup as PARP inhibitors were approved after the OVATION 2 Study was initiated