UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

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

 

For the quarterly period ended:March 31,September 30, 2017

 

or

 

[  ]       TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

[  ]TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _____________ to _____________.

 

Commission File Number:000-13789

 

MARINA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 11-2658569
(State or other jurisdiction of
incorporation or organization)
 (IRS Employer
incorporation or organization)
Identification No.)

 

17870 Castleton Street, Suite 250

City of Industry, California

 91748
(Address of principal executive offices) (Zip Code)

 

(626) 964-5788

(Registrant’s telephone number, including area code)

 

N/A

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

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

[X]      YES Yes [X] No [  ]      NO

 

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

[X]      YES Yes [X] No [  ]      NO

 

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

 

Large accelerated filer[  ]Accelerated filer[  ]
    
Non-accelerated filer[  ] (Do not check if a smaller reporting company)Smaller reporting company[X]
    
  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 7(a)(2)(B) of the Securities Act: [  ]

 

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

. Yes [  ] YES      [X]      NONo [X].

 

As

As of May 15,November 13, 2017, there were 97,169,15310,521,278 shares of the registrant’s common stock outstanding.

 

 

 

 
 

 

MARINA BIOTECH, INC.

FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED MARCH 31,SEPTEMBER 30, 2017

 

TABLE OF CONTENTS

 

  Page
   
PART I -FINANCIAL INFORMATION3
   
ITEM 1Financial Statements (unaudited)3
   
 Condensed Consolidated Balance Sheets as of March 31,September 30, 2017 and December 31, 20163
   
 Condensed Consolidated Statements of Operations for the Three and Nine Months Ended March 31,September 30, 2017 and 20164
   
 Condensed Consolidated Statement of Changes in Stockholders’ DeficitEquity as of September 30, 2017 and December 31, 2016 and March 31, 20175
   
 Condensed Consolidated Statements of Cash Flows for the ThreeNine Months Ended March 31,September 30, 2017 and 20166
   
 Notes to Condensed Consolidated Financial Statements7
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1924
   
ITEM 3.Quantitative and Qualitative Disclosures about Market Risk2834
   
ITEM 4.Controls and Procedures2834
   
PART II -OTHER INFORMATION 
   
ITEM 1.Legal Proceedings35
ITEM 1A.Risk Factors2935
   
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds2935
   
ITEM 6.Exhibits2936
   
SIGNATURES3137

 

Items 1, 3, 4 and 5 have not been included as they are not applicable.

 

2
 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

MARINA BIOTECH, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

 

 March 31, 2017 December 31, 2016  September 30, 2017 December 31, 2016 
 (Unaudited)    (Unaudited) (Audited) 
ASSETS                
                
Current assets                
Cash $216,441  $105,347  $8,676  $105,347 
Prepaid expenses and other assets  184,676   211,133   54,631   211,133 
Total current assets  401,117   316,480   63,307   316,480 
                
Intangible asset, net  2,213,499   2,311,877 
Intangible assets, net of amortization  2,679,235   2,311,877 
Goodwill  3,502,829   3,558,076   3,502,829   3,558,076 
  5,716,328   5,869,953   6,182,064   5,869,953 
                
Total assets $6,117,445  $6,186,433  $6,245,371  $6,186,433 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities                
Accounts payable $618,756  $663,261  $1,027,508  $663,261 
Due to related party  382,332   83,166 
Accrued expenses  717,547   1,393,521   1,022,369   1,393,521 
Due to related party  200,333   83,166 
Accrued fee payable  320,000   - 
Notes payable  436,748   435,998   441,023   435,998 
Convertible note payable to related party  480,514   250,000 
Notes payable to related parties  92,590   - 
Convertible notes payable  406,324   - 
Convertible notes payable to related parties  559,029   250,000 
Fair value of liabilities for price adjustable warrants  244,795   141,723   248,068   141,723 
Derivative liability  115,271   - 
Total current liabilities  2,698,693   2,967,669   4,614,514   2,967,669 
                
Commitments and contingencies (Note 8)                
                
Stockholders’ equity                
Preferred stock, $0.01 par value; 100,000 shares authorized                
                

Series C convertible preferred stock, $0.01 par value; $5,100 liquidation preference; 1,200 shares authorized; 1,020 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively

  -   - 
Series C convertible preferred stock, $0.01 par value; $5,100 liquidation preference; 1,200 shares authorized; 750 and 1,020 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively  -   - 
                
Series D convertible preferred stock, $0.01 par value; $300 liquidation preference; 220 shares authorized; 60 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively  -   - 
Series D convertible preferred stock, $0.01 par value; $300 liquidation preference; 220 shares authorized; 60 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively  -   - 
                
Common stock, $0.006 par value; 180,000,000 shares authorized, 97,099,877 and 89,771,379 shares issued and outstanding as of March 31, 2017 and December 31, 2016, respectively  582,599   538,628 
Common stock, $0.006 par value; 180,000,000 shares authorized, 10,021,220 and 8,977,138 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively  60,127   53,863 
        
Additional paid-in capital  5,870,013   4,631,218   6,850,567   5,115,983 
Deferred compensation  (102,600)  - 
Accumulated deficit  (3,033,860)  (1,951,082)  (5,177,237)  (1,951,082)
                
Total stockholders’ equity  3,418,752   3,218,764   1,630,857   3,218,764 
                
Total liabilities and stockholders’ equity $6,117,445  $6,186,433  $6,245,371  $6,186,433 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3
 

 

MARINA BIOTECH, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

 

 For the Three Months Ended For the Nine Months Ended 
 For the Three Months Ended March 31,  September 30, September 30, 
 2017  2016  2017 2016 2017 2016 
              
Revenue                        
                        
License and other revenues $-  $-  $-  $-  $-  $- 
                        
Operating expenses                        
                        
Personnel expenses  306,922   83,982 
Research and development  73,431   4,978   232,896   50,683   746,221   107,910 
General and administrative  680,063   47,065   1,878,301   232,469 
Amortization  98,378   -   123,038   -   327,642   - 
General and administrative  488,522   25,231 
Total operating expenses  967,253   114,191   1,035,997   97,748   2,952,164   340,379 
                        
Loss from operations  (967,253)  (114,191)  (1,035,997)  (97,748)  (2,952,164)  (340,379)
                        
Other income (expense)                        
                        
Interest expense  (11,653)  -   (24,301)  (378)  (51,575)  (378)
Change in fair value liability of warrants  (103,072)  -   7,442   -   (106,345)  - 
Change in fair value of derivative liability  80,672   -   (115,271)  - 
  (114,725)  -   63,813   (378)  (273,191)  (378)
                        
Loss before provision for income taxes  (1,081,978)  (114,191)  (972,184)  (98,126)  (3,225,355)  (340,757)
                        
Provision for income taxes  800   -   -   800   800   800 
                        
Net loss $(1,082,778) $(114,191) $(972,184) $(98,926) $(3,226,155) $(341,557)
                        
Net loss per share – basic and diluted $(0.01) $(0.00) $(0.10) $(0.02) $(0.33) $(0.08)
                        
Weighted average shares outstanding  94,073,396   38,999,995   9,869,672   4,227,641   9,645,954   4,118,826 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MARINA BIOTECH, INC.

Condensed Consolidated Statements of Changes in Stockholders’ Equity (Capital Deficiency)

(Unaudited)

 

        Additional       
  Common Stock  Paid-in  Accumulated    
  Number  Par Value  Capital  Deficit  Total 
                
Balance, December 31, 2016  89,771,379  $538,628  $4,631,218  $(1,951,082) $3,218,764 
                     
Sale of common stock to related party  862,068   5,172   244,828      250,000 
                     
Common stock issued for services  300,000   1,800  $52,200      54,000 
                     
Common stock issued for accounts payable  6,153,684   36,923  $911,007      947,930 
                     
Return of common stock for note receivable  (87,254)  (524) $(30,880)     (31,404)
                     
Restricted stock issued to officer  100,000   600   17,400      18,000 
                     
Stock option compensation        44,240      44,240 
                     
Net loss           (1,082,778)  (1,082,778)
Balance, March 31, 2017  97,099,877  $582,599  $5,870,013  $(3,033,860) $3,418,752 

  Common Stock  

Additional
Paid-in

  Deferred  Accumulated    
  Number  Par Value  Capital  Compensation  Deficit  Total 
                   
Balance, December 31, 2016  8,977,138  $53,863  $5,115,983  $  $(1,951,082) $3,218,764 
                         
Sale of common stock to related party  86,207   517   249,483         250,000 
                         
Common stock issued for services  30,000   180   53,820         54,000 
                         
Common stock issued for accounts payable  622,296   3,734   972,980         976,714 
                         
Return of common stock for note receivable  (8,725)  (52)  (31,352)        (31,404)
                         
Restricted stock issued to officers  70,000   420   245,580   (102,600)     143,400 
                         
Share based compensation        74,895         74,895 
                         
Exercise of warrants to common stock  60,944   366   170,277         170,643 
                         
Conversion of Series C Preferred to common stock  180,000   1,080   (1,080)          
                         
Effects of rounding due to reverse split  3,360   19   (19)         
                         
Net loss               (3,226,155)  (3,226,155)
Balance, September 30, 2017  10,021,220   60,127  $6,850,567  $(102,600) $(5,177,237)  1,630,857 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MARINA BIOTECH, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

  For the Nine Months Ended September 30, 
  2017  2016 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(3,226,155) $(341,557)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  218,295   - 
Common shares issued for third party services  54,000   - 
Warrants issued for services  -   36,470 
Amortization of intangibles  327,642   - 
Change in fair value liabilities for price adjustable warrants  106,345   - 
Change in fair value of derivative liability  115,271   - 
Changes in operating assets and liabilities:        
Prepaid expenses and other assets  125,098   (479)
Accounts payable  419,494   64,928 
Accrued expenses  637,642   (1,355)
Accrued fee  -   - 
Due to related party  299,166   (54,150)
         
Net Cash Used in Operating Activities  (923,202)  (296,143)
         
Cash Flows Used in Investing Activities:        
         
Purchase of intangible asset  (375,000)  - 
         
Net Cash Used in Investing Activities  (375,000)  - 
         
Cash Flows from Financing Activities:        
         
Proceeds from sale of common stock to related party  250,000   - 
Proceeds from notes payable, related party  90,888   - 
Proceeds from convertible notes  400,000   50,000 
Proceeds from convertible notes, related parties  290,000   - 
Proceeds from exercise of warrants to common stock  170,643   - 
         
Net Cash Provided by Financing Activities  1,201,531   50,000 
         
(Decrease) in cash  (96,671)  (246,143)
         
Cash – Beginning of Period  105,347   261,848 
Cash - End of Period $8,676  $15,705 
         
Supplementary Cash Flow Information:        
Interest paid $-  $- 
Income taxes paid $800  $- 
         
Non-cash Investing and Financing Activities:   ,     
Issuance of warrants for services $-  $36,470 
Common stock issued for accrued expenses $976,714  $- 
Return of common stock for other assets $31,404  $- 
Adjustment to goodwill for change in value of pre-acquisition accounts payable $55,247  $- 
Accrued interest $32,080     
Assumption of Liabilities for acquisition $320,000     

  For the Three Months Ended March 31, 
  2017  2016 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(1,082,778) $(114,191)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  62,240   - 
Common shares issued for third party services  54,000   - 
Warrants issued for services  -   36,470 
Amortization  98,378   - 
Goodwill adjustment  55,247   - 
Fair value liabilities for price adjustable warrants  103,072   - 
Changes in operating assets and liabilities:        
Prepaid expenses and other assets  (4,947)  - 
Accounts payable  (44,505)  11,130 
Accrued expenses  278,156   (59,166)
Due to related party  117,167   (54,150)
         
Net Cash used in operating activities  (363,970)  (179,907)
         
Cash Flows from Financing Activities:        
         
Proceeds from sales of common stock to related party  250,000   - 
Proceed from convertible note, related party  225,064   - 
         
Net cash provided by financing activities  475,064   - 
         
Increase (decrease) in cash  111,094   (179,907)
         
Cash – Beginning of Period  105,347   261,848 
Cash - End of Period $216,441  $81,941 
         
Supplementary Cash Flow Information:        
Interest paid $-  $- 
Income taxes paid $800  $- 
         
Non-cash Investing and Financing Activities:   ,     
Issuance of warrants for services $-  $36,470 
Common stock issued for accounts payable $947,930  $- 
Return of common stock for note receivable $31,404  $- 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

MARINA BIOTECH, INC.

Notes to Condensed Consolidated Financial Statements

FOR THE THREE and NINE MONTHS ENDED MARCH 31,SEPTEMBER 30, 2017

(Unaudited)

 

Note 1 – Nature of Operations, Basis of Presentation and Significant Accounting Policies

 

Business Overview

Marina Biotech, Inc. and its wholly-owned subsidiaries, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc., Atossa Healthcare, Inc., and IthenaPharma, Inc. (collectively “Marina,” “we,” “our,” or “us”) is a fully integrated, commercial stage biopharmaceutical company delivering proprietary drug therapeutics for significant unmet medical needs in the U.S., Europe and certain additional international markets. Its portfolio of products currently focuses on fixed dose combinations (“FDC”) in hypertension, arthritis, pain and oncology allowing for innovative solutions to such unmet medical needs. Its mission is to provide effective and patient centric treatment for hypertension – including resistant hypertension. In this connection, we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also called Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care.

In doing so, we have created a universal platform for the effective treatment of hypertension as well as for the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, and the other products in our pipeline, devices for therapeutic drug monitoring, blood pressure, and other cardiac monitors, as well as services such as counseling and prescription reminders.

We currently have one commercial and three clinical development programs underway: (i) Prestalia®, a single-pill fixed dose combination of perindopril, an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine, a calcium channel blocker (“CCB”), which has been approved by the U.S. Food and Drug Administration (“FDA”) and is actively marketed in the U.S.; (ii) our next generation celecoxib program drug candidates for the treatment of acute and chronic pain, IT-102 and IT-103, each of which is an FDC of celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (“NSAID”) and either lisinopril (IT-102) or olmesartan (IT-103) – both Lisinopril and olmesartan are antihypertension drugs; (iii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (“FAP”); and (iv) CEQ508 combined with IT-103 to treat Colorectal Cancer.

Our current focus is primarily on the commercialization of Prestalia and secondarily the development of IT-102 and IT-103. We believe that by combining a COX-2 inhibitor with an antihypertensive in a single FDC oral tablet, IT-102 and IT-103 will each offer improved safety profiles as compared to currently available and previously marketed COX-2 inhibitors as well as address patients with chronic pain who are commonly taking antihypertension drugs concurrently. We further believe that the current opioid addiction epidemic in the U.S. has been driven in part by the withdrawal from the market of certain COX-2 inhibitors due to their associated risk of cardiovascular-related adverse events. We plan to license or divest our other assets since they no longer align with our focus on the treatment of hypertension.

We intend to create value through the continued commercialization of our FDA-approved product, Prestalia, while moving our FDC development programs forward to further strengthen our commercial presence. We intend to retain ownership and control of all of our product candidates, but in the interest of accelerated growth and market penetration, we will also consider partnerships with pharmaceutical or biotechnology companies in order to reduce time to market and to balance development risks, both clinically and financially.

As our strategy is to be a fully integrated biopharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, with a secondary focus on advancing our FDC pipeline to further enhance our commercial presence.

Reverse Merger with IThenaPharma

 

On November 15, 2016, Marina Biotech, Inc. and subsidiaries (“Marina” or the “Company”) entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among IThenaPharmaIthenaPharma, Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). Upon completion of the Merger and subject to the applicable provisions of the Merger Agreement, Merger Sub has ceased to exist and IThena continues as the surviving corporation of the Merger and asFor a wholly-owned subsidiary of Marina. As consideration for the Merger, Marina issued to the former shareholders of IThena 58,392,828 shares of the Company’s common stock, representing approximately 65% of the issued and outstanding shares of Marina’s common stock following the completion of the Merger. Outstanding warrants to purchase 300,000 shares of common stock of IThena were converted into warrants to purchase common stock of Marina. In addition, Marina appointed Vuong Trieu, the president of IThena, as the Chairman of the Board of Directors of Marina, effective November 15, 2016. Dr. Trieu, in his capacity as the IThena representative, later appointed Philippe P. Calais, Ph.D., as a member of the Board of Directors of Marina effective December 8, 2016, pursuant to the rights granted to the former shareholders of IThena in the Merger Agreement.

As the former shareholders of IThena control greater than 50% of the Company subsequent to the Merger, for accounting purposes, the Merger was treated as a “reverse acquisition” and IThena is considered the accounting acquirer. Accordingly, IThena’s historical results of operations replace Marina’s historical results of operations for all periods prior to the Merger, and for all periods following the Merger, the results of operations of both companies are included. IThena accounted for the acquisition of Marina under the purchase accounting method following completion.

The purchase price of approximately $3.7 million represents the consideration inmore detailed discussion on the reverse merger, transaction and is calculated basedrefer to Note 2 – Intangible Assets below as well as our 2016 Annual Report on the number of shares of common stock of the combined company that Marina stockholders owned as of the closing of the transaction and the fair value of assets and liabilities assumed by IThena.

The number of shares of common stock Marina issued to IThena stockholders is calculated pursuant to the terms of the Merger Agreement based on Marina common stock outstanding as of November 15, 2016, as follows:

Shares of Marina common stock outstanding as of November 15, 201631,378,551
Divided by the percentage of Marina ownership of combined company35%
Adjusted total shares of common stock of combined company89,771,379
Multiplied by the assumed percentage of IThena ownership of combined company65%
Shares of Marina common stock issued to IThena upon closing of transaction58,392,828

The application of the acquisition method of accounting is dependent upon certain valuations and other studies that have yet to be completed. The purchase price allocation will remain preliminary until IThena management determines the fair values of assets acquired and liabilities assumed. The final determination of the purchase price allocation is anticipated to be completed as soon as practicable after completion of the transaction and will be based on the fair values of the assets acquired and liabilities assumed as of the transaction closing date. The final amounts allocated to assets acquired and liabilities assumed could differ significantly from the amounts presented.

The purchase price as of March 31, 2017 has been allocated based on a preliminary estimate of the fair value of assets acquired and liabilities assumed:

Assets and Liabilities Acquired:    
Cash $5,867 
Net current liabilities assumed (excluding cash)  (1,871,725)
Identifiable intangible assets  2,361,066 
Debt  (326,037)
Net assets acquired  169,170 
Goodwill  3,502,829 
Purchase price $3,672,000 

The above estimated purchase allocation and goodwill valuation reflects changes in fair value determinations of $55,246 for the three months ended March 31, 2017 and approximately $1,238,000 since the merger date.

In connectionForm 10K filed with the Merger, Marina entered into a License Agreement with Autotelic LLC, a stockholder of IThena and an entity in which Dr. Trieu serves as Chief Executive Officer, pursuant to which (A) Marina licensed to Autotelic LLC certain patent rights, data and technology relating to Familial Adenomatous Polyposis and nasal insulin, for human therapeutics other than for oncology-related therapies and indications, and (B) Autotelic LLC licensed to Marina certain patent rights, data and know-how relating to IT-102 and IT-103, in connection with individualized therapy of pain using a non-steroidal anti-inflammatory drug and an anti-hypertensive without inducing intolerable edema, and treatment of certain aspects of proliferative disease, but not including rights to IT-102/IT-103 for Therapeutic Drug Monitoring (“TDM”) guided dosing for all indications using an Autotelic Inc. TDM Device. We also granted a right of first refusal to Autotelic LLC with respect to any license by us of the rights licensed by or to us under the License Agreement in any cancer indication outside of gastrointestinal cancers.

On November 15, 2016, simultaneously with the Merger, Autotelic Inc., a related party, acquired a technology asset (IT-101) from IThena, and IThena’s investment of $479 in a foreign entity from the Company. In exchange for the asset, Autotelic Inc. agreed to cancel its stock purchase warrant agreements (see below), received all of IThena’s then cash balance as payment against the liabilities and agreed to assume the remaining debts and liabilities of IThena, including accounts payable of $71,560, accrued expenses of $11,470, due to related party of $5,375, other liabilities of $118,759, convertible note of $50,000, and accrued interest payable of $567. IThena recognized contributed capital of $257,252 in connection with this transaction.

In connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, our Chairman of the Board, for an unsecured line of credit to be used for current operating expenses in an amount not to exceed $540,000, of which $475,064 had been drawn at March 31, 2017 and $250,000 had been drawn at December 31, 2016. Dr. Trieu considered requests for advances under the Line Letter until April 30, 2017. Dr. Trieu has the right at any time for any reason in his sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice; provided, that Dr. Trieu agreed that he shall not demand the repayment of any advances that are made under the Line Letter prior to the earlier of: (i) May 15, 2017; and (ii) the date on which (x) we make a general assignment for the benefit of our creditors, (y) we apply for or consent to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of our assets or (z) we cease operations. Dr. Trieu has advanced an aggregate of $475,064 under the Line Letter. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissory Note issued by us to Dr. Trieu, and are due and payable upon demand by Dr. Trieu.

Dr. Trieu has the right, exercisable by delivery of written notice thereof (the “Election Notice”), to either: (i) receive repayment for the entire unpaid principal amount advanced under the Line Letter and the accrued and unpaid interest thereon on the date of the delivery of the Election Notice (the “Outstanding Balance”) or (ii) convert the Outstanding Balance into such number of shares of our common stock as is equal to the quotient obtained by dividing (x) the Outstanding Balance by (y) $0.10 (such price, the “Conversion Price”); provided, that in no event shall the Conversion Price be lower than the lower of (x) $0.28 per share or (y) the lowest exercise price of any securities that have been issued by us in a capital raising transaction (and that would otherwise reduce the exercise price of any other outstanding warrants issued by us) during the period between November 15, 2016 and the date of the delivery of the Election Notice. No capital raising transactions have occurred through the date of this filing with securities at a price lower than $0.28 per share.

Further, we entered into a Master Services Agreement (“MSA”) with Autotelic Inc., a stockholder of IThena, pursuant to which Autotelic Inc. agreed to provide certain business functions and services from time to time during regular business hours at our request. See Note 3 for specific terms of the MSA.

On November 15, 2016, Marina agreed to issue to Novosom Verwaltungs GmbH (“Novosom”) 1.5 million shares of common stock upon the closing of the Merger in consideration of Novosom’s agreement that the consummation of the Merger would not constitute a “Liquidity Event” under that certain Asset Purchase Agreement dated as of July 27, 2010 between and among Marina, Novosom and Steffen Panzner, Ph.D., and thus that no additional consideration under such agreement would be due to Novosom as a result of the consummation of the Merger.

In July 2016, Marina pledged to issue common stock valued at approximately $15,000 to Novosom for the portion due under our July 2010 Asset Purchase Agreement with Novosom, related to Marina’s license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. In November 2016, we issued 119,048 shares with a value of approximately $15,000 to Novosom as the equity component owed under our July 2016 license agreement.

Business Operations

IThenaPharma, Inc.SEC.

 

IThena is a developer of personalized therapies for combined pain/hypertension through its proprietary Fixed Dose Combination (“FDC”) technology and point of care TDM.Therapeutic Drug Monitoring (“TDM”). Through the combination of these technologies, IThenaPharma is looking to deliver therapies with improved compliance and personalized dosing. IThena’s lead products are the celecoxib FDCs which include IT-102 and IT-103, fixed dose combinations of celecoxib and lisinopril and celecoxib and olmesartan, respectively. IT-102 and IT-103 are being developed as celecoxib without the drug induced edema associated with celecoxib alone. IT-102 and IT-103 are being developed initially for combined arthritis / hypertension and subsequently for treatment of pain, or cancer, or other indications requiring high doses of celecoxib.

 

Marina Biotech, IncReverse Stock Split

 

Marina Biotech, Inc. (“Marina”) isOn August 1, 2017, we filed a biopharmaceutical company engaged inCertificate of Amendment of our Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse split of our issued and outstanding shares of common stock. Our common stock commenced trading on the discovery, acquisition, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs in the U.S., Europe and additional international markets. Marina’s primary therapeutic focus is the disease intersection of hypertension, arthritis, pain, and oncology allowing for innovative combination therapiesOTCQB tier of the plethora of already approved drugsOTC Markets on a split-adjusted basis on Thursday, August 3, 2017. Unless indicated otherwise, all share and per share information included in these financial statements give effect to the proprietary novel oligotherapeutics of Marina.

Marina currently has three clinical development programs underway: (i) next generation celecoxib program drug candidates IT-102 and IT-103, each of which is a fixed dose combination of celecoxib and either lisinopril (IT-102) or olmesartan (IT-103); (ii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication of Familial Adenomatous Polyposis (“FAP”); and (iii) CEQ508 combined with IT-103 to treat Colorectal Cancer (“CRC”).reverse split.

 

Summary of Significant Accounting Policies

Basis of Presentation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and in accordance with the instructions to Form 10-Q and Article 108 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete audited financial statements. The accompanying unaudited financial information should be read in conjunction with the audited consolidated financial statements, including the notes thereto, as of and for the year ended December 31, 2016, included in our 2016 Annual Report on Form 10-K filed with the SEC. The information furnished in this report reflects all adjustments (consisting of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. The results of operations for the threenine months ended March 31,September 30, 2017 are not necessarily indicative of the results for the year ending December 31, 2017 or for any future period.

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of IThenaPharma Inc. and Marina Biotech, Inc. and the wholly-owned subsidiaries, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions.

 

Going Concern and Management’s Liquidity Plans

 

The accompanying condensed consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At March 31,September 30, 2017, we had ana significant accumulated deficit of $3,033,860$5,177,237 and a negative working capital of $2,297,576.$4,551,207. We had obtained a line of credit from Autotelic Inc. of $500,000, of which we have utilized $92,590. As such, we currently have approximately $407,000 of available funds under our line of credit under this line of credit with Autotelic Inc. We believe this amount of available funds is sufficient to fund our operations through December 31, 2017. Our operating activities consume the majority of our cash resources. We anticipate that we will continue to incur operating losses as we execute our plan to raise additional funds and investigatecommercialization plans, as well as strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from operations.operations, at least into the near future. We have previously funded, and plan to continue funding, our losses primarily through the sale of common and preferred stock, andcombined with or without warrants, the sale of notes, revenue provided from our license agreements and, to a lesser extent, equipment financing facilities and secured loans. However, we cannot be certain that we will be able to obtain such funds required for our operations at terms acceptable to us or at all. In 2016, and 2015, we funded operations with a combination ofprimarily through the issuance of notes and preferred stock,convertible debt and license-related revenues. At March 31, 2017, we had a cash balance of $216,441. Our operating activities consume the majority of our cash resources.

There is substantial doubt about our ability to continue as a going concern for one year from the issuance date of this Form 10-Q, which may affect our ability to obtain future financing or engage in strategic transactions, and may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional equity or debt financing, or whether such actions would generate the expected liquidity as currently planned.

 

Summary of Significant Accounting Policies

Use of Estimates

 

The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include valuation allowance for deferred income tax assets.assets and fair value of financial instruments. Actual results could differ materially from such estimates under different assumptions or circumstances.

 

Fair Value of Financial Instruments

 

We consider the fair value of cash, accounts payable, due to related parties, notes payable, notes payable to related parties, convertible notes payable and accrued liabilities not to be materially different from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

 

Level 1:Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
  
Level 2:Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
  
Level 3:Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use.

 

Our cash is subject to fair value measurement and is determined by Level 1 inputs. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. We measure the liability for price adjustable warrants and certain features embedded in notes, using the probability adjusted Black-Scholes option pricing model (“Black-Scholes”), which management has determined approximates values using more complex methods, using Level 3 inputs. The following tables summarize our liabilities measured at fair value on a recurring basis as of September 30, 2017 and December 31, 2016 and March 31, 2017:2016:

  Balance at
September 30, 2017
  Level 1
Quoted
prices in
active markets for
identical assets
  Level 2
Significant
other
observable
inputs
  

Level 3
Significant
unobservable

Inputs

 
Liabilities:                
Fair value liability for price adjustable warrants $248,068  $-  $-  $248,068 
Derivative liability  115,271   -   -   115,271 
Total liabilities at fair value $363,339  $-  $-  $363,339 

 

  

Balance at

December 31, 2016

  Level 1
Quoted
prices in
active
markets for
identical
assets
  Level 2
Significant
other
observable
inputs
  Level 3
Significant
unobservable inputs
 
Liabilities:                
Fair value liability for price adjustable warrants $141,723  $-  $-  $141,723 
Total liabilities at fair value $141,723  $-  $-  $141,723 

 

Balance at
March 31, 2017

  Level 1
Quoted
prices in
active
markets for
identical
assets
 Level 2
Significant
other
observable
inputs
  

Level 3
Significant
unobservable

inputs

  

Balance at

December 31, 2016

  Level 1
Quoted
prices in
active markets for
identical assets
 Level 2
Significant
other
observable
inputs
 Level 3
Significant
unobservable inputs
 
Liabilities:                                
Fair value liability for price adjustable warrants $244,795  $-  $-  $244,795  $141,723  $-  $-  $141,723 
Total liabilities at fair value $244,795  $-  $-  $244,795  $141,723  $-  $-  $141,723 

 

The following presents activity of the fair value liability of price adjustable warrants determined by Level 3 inputs for the period ended March 31,September 30, 2017:

 

  Fair value
liability for
price
adjustable
warrants
 
    
Balance at December 31, 2016 $141,723 
Fair value of warrants issued  - 
Exercise of warrants  - 
Change in fair value included in condensed consolidated statement of operations  103,072 
Balance at March 31, 2017 $244,795 
  Fair value
liability for
price adjustable
warrants
 
    
Balance at December 31, 2016 $141,723 
Change in fair value included in condensed consolidated statement of operations  106,345 
Balance at September 30, 2017 $248,068 

 

The fair value liability of price adjustable warrants for the threenine months ended March 31,September 30, 2017 was determined using the probability adjusted Black-Scholes option pricing model using exercise prices of $0.28$2.80 to $0.75,$7.50, stock price of $0.28,$2.70, volatility of 123%174% to 184%225%, contractual lives of 2.50.1 to 64.1 years, and risk freerisk-free rates of 0.62% to 1.93%.

The following presents activity of the derivative liability determined by Level 3 inputs for the period ended September 30, 2017:

  

Fair value
of derivative

liability

 
    
Balance at December 31, 2016 $- 
Additions  195,943 
Change in fair value included in condensed consolidated statement of operations  (80,672)
Balance at September 30, 2017 $115,271 

The fair value liability of derivative liability for the nine months ended September 30, 2017 was determined using the binomial pricing model using exercise prices of $2.80, stock price of $2.70, volatility of 168%, contractual life of 1 year, and a risk-free rate of 1.31%.

Impairment of Long-Lived Assets

 

We review all of our long-lived assets for impairment indicators throughout the year and perform detailed testing whenever impairment indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets, at least annually, at December 31. When necessary, we record charges for impairments. Specifically:

 

For finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and
  
For indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair value, if any.

 

Management determined that no impairment indicators were present and that no impairment charges were necessary as of March 31,September 30, 2017 or December 31, 2016.

 

Net Income (Loss) per Common Share

 

Basic net income (loss) per common share (after giving effect of the one for ten reverse stock split) is computed by dividing the net income (loss) by the weighted average number of common shares outstanding during the period.period, excluding any unvested restricted stock awards. Diluted net income (loss) per share includes the effect of common stock equivalents (stock options, unvested restricted stock, and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. Net income (loss) is adjusted for the dilutive effect of the change in fair value liability for price adjustable warrants, if applicable. The following number of shares have been excluded from diluted net income (loss) since such inclusion would be anti-dilutive:

 

  Three Months Ended March 31, 
  2017  2016 
       
Stock options outstanding  2,334,000   - 
Warrants  27,029,995   139,173 
Convertible Notes Payable  1,716,123   - 
Total  31,080,118   139,173 

Subsequent Events

Except for the event(s) discussed in Note 9, there were no subsequent events that required recognition or disclosure. The Company evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission.

  Nine months ended
September 30,
 
  2017  2016 
       
Stock options outstanding  233,400   - 
Warrants  2,492,945   13,917 
Convertible Notes Payable  315,746   - 
Restricted common stock  70,000     
Total  3,112,091   13,917 

 

Note 2 – Intangible Assets

 

Reverse Merger with IThenaPharma

On November 15, 2016, we entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among Marina Biotech, Inc., IThenaPharma Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). Upon completion of the Merger and subject to the applicable provisions of the Merger Agreement, Merger Sub has ceased to exist and IThena continues as the surviving corporation of the Merger and as a wholly-owned subsidiary of Marina. As consideration for the Merger, Marina issued to the former shareholders of IThena 58,392,828 shares of the Company’s common stock (5,839,283 shares after adjustment for the Company’s 1 for 10 reverse stock split in August 2017), representing approximately 65% of the issued and outstanding shares of Marina’s common stock following the completion of the Merger. Outstanding warrants to purchase 30,000 shares of common stock of IThena were converted into warrants to purchase common stock of Marina. In addition, Marina appointed Vuong Trieu, the president of IThena, as the Chairman of the Board of Directors of Marina, effective November 15, 2016. Dr. Trieu, in his capacity as the IThena representative, later appointed Philippe P. Calais, Ph.D., as a member of the Board of Directors of Marina effective December 8, 2016, pursuant to the rights granted to the former shareholders of IThena in the Merger Agreement.

As the former shareholders of IThena control greater than 50% of the Company subsequent to the Merger, for accounting purposes, the Merger was treated as a “reverse acquisition” and IThena is considered the accounting acquirer. IThena accounted for the acquisition of Marina under the purchase accounting method following completion. Accordingly, IThena’s historical results of operations replace Marina’s historical results of operations for all periods prior to the Merger, and for all periods following the Merger, the results of operations of both companies are included. As a result of the Merger, while we have presented the results for the three and nine months ended September 30, 2017 and 2016; the results for the 2016 periods reflect only the results of IThena.

The purchase price of approximately $3.7 million represents the consideration in the reverse merger transaction and is calculated based on the number of shares of common stock of the combined company that Marina stockholders owned as of the closing of the transaction and the fair value of assets and liabilities assumed by IThena.

The number of shares of common stock Marina issued to IThena stockholders is calculated pursuant to the terms of the Merger Agreement based on Marina common stock outstanding as of November 15, 2016, as follows (retroactively adjusted for the 1 for 10 reverse stock split in August 2017):

Shares of Marina common stock outstanding as of November 15, 20163,137,855
Divided by the percentage of Marina ownership of combined company35%
Adjusted total shares of common stock of combined company8,977,138
Multiplied by the assumed percentage of IThena ownership of combined company65%
Shares of Marina common stock issued to IThena upon closing of transaction5,839,283

The application of the acquisition method of accounting is dependent upon certain valuations and other studies that have yet to be completed. The purchase price allocation will remain preliminary until IThena management determines the fair values of assets acquired and liabilities assumed. The final determination of the purchase price allocation is anticipated to be completed as soon as practicable after completion of the transaction and will be based on the fair values of the assets acquired and liabilities assumed as of the transaction closing date. The final amounts allocated to assets acquired and liabilities assumed could differ significantly from the amounts presented.

The purchase price as of September 30, 2017 has been allocated based on a preliminary estimate of the fair value of assets acquired and liabilities assumed:

Assets and Liabilities Acquired:    
Cash $5,867 
Net current liabilities assumed (excluding cash)  (1,871,725)
Identifiable intangible assets  2,361,066 
Debt  (326,037)
Net assets acquired  169,171 
Goodwill  3,502,829 
Purchase price $3,672,000 

The above estimated purchase price allocation and goodwill valuation reflects changes in fair value determinations of $55,246 for the nine months ended September 30, 2017 and approximately $1,238,000 since the Merger date. As part of the Merger, the Company allocated $3,502,829 to goodwill. Additionally, a substantial portion of the assets acquired were allocated to identifiable intangible assets. The fair value of the identifiable intangible asset is determined primarily using the “income approach,” which requires a forecast of all the expected future cash flows.

 

On November 15, 2016, Marina agreed to issue to Novosom Verwaltungs GmbH (“Novosom”) 0.15 million shares of common stock upon the closing of the Merger in consideration of Novosom’s agreement that the consummation of the Merger would not constitute a “Liquidity Event” under that certain Asset Purchase Agreement dated as of July 27, 2010 between and among Marina, Novosom and Steffen Panzner, Ph.D., and thus that no additional consideration under such agreement would be due to Novosom as a result of the consummation of the Merger.

In July 2016, Marina pledged to issue common stock valued at approximately $15,000 to Novosom for the portion due under our July 2010 Asset Purchase Agreement with Novosom, related to Marina’s license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. In November 2016, we issued 11,905 shares with a value of approximately $15,000 to Novosom as the equity component owed under our July 2016 license agreement.

Acquisition of Assets from Symplmed

In June 2017, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Symplmed Pharmaceuticals LLC (“Symplmed”) pursuant to which we purchased from Symplmed, for aggregate consideration of approximately $0.62 million (consisting of $0.4 million in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $0.32 million), Symplmed’s assets relating to a single-pill FDC of perindopril arginine and amlodipine besylate known as Prestalia® (“Prestalia”), that has been approved by the FDA for the treatment of hypertension. In addition, as part of the transactions contemplated by the Purchase Agreement: (i) Symplmed agreed to transfer to us, not later than 150 days following the closing date, the New Drug Applications for the approval of Prestalia as a new drug by the FDA; and (ii) Symplmed assigned to us all of its rights and obligations under that certain Amended and Restated License and Commercialization Agreement by and between Symplmed and Les Laboratoires Servier (“Servier”) dated January 11, 2012, pursuant to which Symplmed has an exclusive license from Servier to manufacture, have manufactured, develop, promote, market, distribute and sell Prestalia in the U.S. (and its territories and possessions) in consideration of regulatory and sales-based milestone payments and royalty payments based on net sales. Management has determined that this acquisition was deemed an asset purchase under FASB ASC 805.

Further, we entered into an offer letter to hire our current Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective on June 22, 2017. We also agreed in such offer letter to issue 60,000 restricted shares of our common stock under our 2014 Long-Term Incentive Plan to our Chief Commercial Officer, with all of such shares to vest on the six (6) month anniversary of the date of grant.

In furtherance of the acquisition and commercialization of Prestalia, on July 21, 2017 we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also known as Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care.

The purchase price of $0.62 million has been allocated based on a preliminary estimate of the fair value of the assets acquired and is included in intangible assets as of September 30, 2017, and is subject to change.

The following table summarizes the estimated fair value of the identifiable intangible asset acquired, their useful life, and method of amortization:

  Estimated
Fair Value
  Estimated
Useful Life
(Years)
  Annual
Amortization
Expense
 
Intangible asset $2,361,066   6  $393,511 
  Estimated
Fair Value
  Estimated
Useful Life
(Years)
  Annual
Amortization
Expense
 
Intangible asset from Merger $2,361,066   6  $393,511 
Intangible asset - Prestalia  620,000   6   103,333 
Intangible asset – DyrctAxess  75,000   6   12,500 
Total $3,056,066      $509,344 

 

The net intangible asset was $2,213,499,$2,679,235, net of accumulated amortization of $147,567,$376,831, as of March 31,September 30, 2017. Amortization expense was $98,378$327,642 and $0 for the threenine months ended March 31,September 30, 2017 and 2016, respectively.

 

Note 3 - Related Party Transactions

 

Due to Related Party

 

The Company and other related entities have a commonality of ownership and/or management control, and as a result, the reported operating results and /or financial position of the Company could significantly differ from what would have been obtained if such entities were autonomous.

 

The Company has a Master Services Agreement (“MSA”) with a related party that is partly-owned by the Company’s Executive Chairman, Autotelic Inc., effective January 1, 2015.November 15, 2016. Autotelic Inc. owns less than 10% of the Company. The MSA states that Autotelic Inc. will provide business functions and services to the Company and allows Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The MSA between Marina and Autotelic Inc. was effective on the reverse merger date of November 15, 2016.

 

During the period commencing January 1, 2015November 15, 2016 (the “Effective Date”) and ending on the date that the Company has completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10,000,000$10 million (the “Equity Financing Date”), the Company shall pay Autotelic the following compensation: cash in an amount equal to the actual labor cost (paid on a monthly basis), plus 100% markup in warrants for shares of the Company’s common stock with a strike price equal to the fair market value of the Company’s common stock at the time said warrants are issued. The Company shall also pay Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share iswill be calculated based on the Black-Scholes model.

 

After the Equity Financing Date, the Company shall pay Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided services and 20% mark up of provided services by third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations (“CMO”), U.S. Food & Drug Administration (“FDA”)FDA regulatory process, Contract Research Organizations (“CRO”) and Chemistry and Manufacturing Controls (“CMC”).

 

In accordance with the MSA, Autotelic Inc. billed the Company for personnel and service expenses Autotelic Inc. incurred on behalf of the Company. Personnel cost charged by Autotelic Inc. were $158,140 and $41,991 forFor the threenine months ended on March 31, 2017 and 2016, respectively. For the three months ended March 31,September 30, 2017 and 2016, Autotelic Inc. billed a total of $213,103$492,406 and $72,231,$238,673, including personnel costs (above),of $386,954 and $99,425, respectively. TheAn unpaid balance of $200,333$382,332 is recorded as due to related party in the accompanying balance sheet as of March 31,September 30, 2017. The Company agreed to issue warrants at a future date for the remaining balance due of $178,572,$388,745, which is included in accrued expenses as of March 31,September 30, 2017.

 

Convertible Notes Payable

 

In July 2016, IThena issued convertible promissory notes with an aggregate principal balance of $50,000 to certain related-party investors. Borrowings under each of these convertible notes bore interest at 3% per annum and these notes mature on June 30, 2018. Upon the completion of certain funding events, the Company hasIThena had the right to convert the outstanding principal amount of these notes into shares of the Company’sIThena’s common stock at $1.80 per share.stock. The notes were assumed by Autotelic Inc. on November 15, 2016 as part of its acquisition of the technology asset (IT-101).

Convertible Notes Payable, Dr. Trieu

 

In connection with the Merger, Marina entered into thea Line Letter dated November 15, 2016 with Dr. Trieu, our Executive Chairman, of the Board, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses, as described in Note 1 above.expenses. Dr. Trieu has advanced an aggregate of $475,064the full $540,000 under the Line Letter as of MarchSeptember 30, 2017 ($250,000 as of December 31, 2017.2016). Accrued interest on the Line Letter was $5,450$19,029 and $0 as of MarchSeptember 30, 2017 and December 31, 20172016, respectively, and is included in convertible notes payable to related parties on the accompanying balance sheets. The line of credit is currently convertible at any time into shares of the Company’s common stock at a price of $2.80 per share.

Line Letter with Autotelic Inc.

 

On April 4, 2017, the Company entered into a Line Letter with Autotelic Inc for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses. Autotelic Inc. is., a stockholder of IThenaPharma that became the holder of 5,255,354525,535 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board, for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses.Board. Autotelic Inc. willwas to consider requests for advances under the Line Letter until September 1, 2017. The Company and Autotelic Inc. are in discussions to extend this line letter through December 31, 2017. Autotelic Inc. shall have the right at any time for any reason in its sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice; provided, that Autotelic Inc. agreed that it shall not demand the repayment of any advances that are made under the Line Letter prior to the earlier of: (i) October 4, 2017; and (ii) the date on which (x) we make a general assignment for the benefit of our creditors, (y) we apply for or consents to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of our assets or (z) we cease operations.notice. Advances made under the Line Letter shall bear interest at the rate of five percent (5%) per annum, shall beare evidenced by the Demand Promissory Note issued to Autotelic Inc., and shall beare due and payable upon demand by Autotelic, Inc.

The balance under the line was $92,590 as of September 30, 2017 and is included in notes to related parties on the accompanying balance sheet. As such, we currently have approximately $407,000 of available funds under this line of credit.

 

Note 4 – Notes Payable

 

Note Purchase Agreement and Amendment

 

OnIn June 20, 2016, Marina entered into a Note Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Purchasers”), pursuant to which Marina issued to the Purchasers unsecured promissory notes in the aggregate principal amount of $300,000 (the “Notes”). Interest shallwas to accrue on the unpaid principal balance of the Notes at the rate of 12% per annum beginning on September 20, 2016. The Notes will becomewere due and payable on June 20, 2017, provided, that, upon the closing of a financing transaction that occurs while the Notes are outstanding, each Purchaser shall have the right to either: (i) accelerate the maturity date of the Note held by such Purchaser or (ii) convert the entire outstanding principal balance under the Note held by such Purchaser and accrued interest thereon into Marina’s securities that are issued and sold at the closing of such financing transaction.

 

Further, if we at any time while the Notes are outstanding receive any cash payments in the aggregate amount of not less than $250,000, as a result of the licensing, partnering or disposition of any of the technology held by us or any related product or asset, we shall pay to the holders of the Notes, on a pro rata basis, an amount equal to 25% of each payment actually received by us, which payments shall be applied against the outstanding principal balance of the Notes and the accrued and unpaid interest thereon, until such time as the Notes are repaid in full.

As of March 31, 2017, the accrued interest expense on the Notes amounted to $21,225, with a total balance of principal and interest of $321,225.

In the Purchase Agreement, Marina agreed: (x)July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to extend the termination date of all ofthose Notes and the warrants to purchase shares of Marinaour common stock (such warrants,that are currently held by the “Prior Warrants”)Purchasers and that were delivered to the purchasersoriginally issued pursuant to thata certain Note and Warrant Purchase Agreement dated as of February 10, 2012 betweenby and among Marina, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto as it has been(as amended from time to time), to, among other things, extend the maturity date of the Notes to December 31, 2017 and to extend the price protection applicable to certain of the warrants held by the Purchasers with respect to dilutive offerings afforded thereunder to February 10, 20202020. Refer to our Form 10-Q for the six months ended June 30, 2017 for a more detailed discussion and (y) to extend the exercise price protection afforded of the Prior Warrants so that such protection would apply to any financing transaction effected on or prior to June 19, 2017 (with any such adjustment only applying to 80% of the Prior Warrants, and with such protection not resulting in the issuance of any additional shares of Marina common stock). As the Prior Warrants were already recorded at fair value as a result of price adjustable terms the impacts of the modification of the terms is included in the change in fair value of price adjustable warrants in the statement of operations.for these Notes.

 

These notes were assumed by IThena in connectionAs of September 30, 2017, the accrued interest expense on the Notes amounted to $37,500, with the Merger.

a total balance of principal and interest of $337,500.

Note Payable – Service Provider

 

OnIn December 28, 2016, we entered into an Agreement and Promissory Note with a law firm for past services performed totaling $121,523. The note calls for monthly payments of $6,000 per month, beginning with an initial payment on March 31, 2017. The note is unsecured and non-interest bearing. The note will be considered paid in full if the Company pays $100,000 by December 31, 2017. The balance due on the note was $115,523$103,523 as of March 31,September 30, 2017.

Bridge Note Financing

In June 2017, we issued convertible promissory notes (the “Notes”) in the aggregate principal amount of $400,000 to 10 investors pursuant to a Note Purchase Agreement (the “Note Purchase Agreement”) that we entered into with such investors. The Notes bear interest at a rate of five percent (5%) per annum and are due and payable at any time on or after the earlier of (i) June 1, 2018 and (ii) the occurrence of an event of default (as defined in the Note Purchase Agreement). Our Executive Chairman and our Chief Science Officer were each investors in the Notes.

Upon written notice delivered to us by the holders of a majority in interest of the aggregate principal amount of Notes that are outstanding at the time of such calculation (the “Majority Holders”) not more than five (5) days following the maturity date of the Notes, the Majority Holders shall have the right, but not the obligation, on behalf of themselves and all other holders of Notes, upon written notice delivered to us, to elect to convert the entire unpaid principal amount of all, but not less than all, of the Notes and the accrued and unpaid interest thereon into such number of shares of our common stock as is equal to, with respect to each Note: (x) the entire unpaid principal amount of such Note and the accrued and unpaid interest thereon on the date of the delivery of such notice by (y) $3.50.

As of September 30, 2017, the accrued interest expense on the Notes amounted to $6,324, with a total balance of principal and interest of $406,324.

 

Note 5 – Stockholders’ Equity

 

Preferred Stock

 

Marina designated 1,000 shares as Series B Preferred Stock (“Series B Preferred”) and 90,000 shares as Series A Junior Participating Preferred Stock (“Series A Preferred”). No shares of Series B Preferred or Series A Preferred are outstanding. In March 2014, Marina designated 1,200 shares as Series C Convertible Preferred Stock (“Series C Preferred”). In August 2015, Marina designated 220 shares as Series D Convertible Preferred Stock (“Series D Preferred”).

 

Series C Preferred

Each share of Series C Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $7.50 per share. In June 2015, an investor converted 90 shares of Series C Preferred into 60,000 shares of common stock with a value of $5.40 per share. In November 2015, an investor converted an additional 90 shares of Series C Preferred into 60,000 shares of common stock with a value of $3.10 per share. On September 15, 2017, an investor converted 270 shares of Series C Preferred stock into 180,000 shares of our common stock in a cashless exercise.

Series D Preferred

In August 2015, Marina entered into a Securities Purchase Agreement with certain investors pursuant to which Marina sold 220 shares of Series D Preferred, and warrants to purchase up to 3.44 million344,000 shares of Marina’s common stock at an initial exercise price of $0.40$4.00 per share before August 2021, for an aggregate purchase price of $1.1 million. Marina incurred $0.01 million of stock issuance costs in conjunction with the Series D Preferred, which were netted against the proceeds. The warrants issued in connection with Series D Preferred contain an exercise price protection provision whereby the exercise price per share to purchase common stock covered by these warrants is subject to reduction in the event of certain dilutive stock issuances at any time within two years of the issuance date, but not to be reduced below $0.28 per share. Any such adjustment will not result in the issuance of any additional shares of Marina’s common stock. Each share of Series D Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.40$4.00 per share. The Series D Preferred is initially convertible into an aggregate of 2,750,000275,000 shares of Marina’s common stock, subject to certain limitations and adjustments, has a 5% stated dividend rate, is not redeemable and has voting rights on an as-converted basis.

To account for the issuance of the Series D Preferred and warrants, Marina first assessed the terms of the warrants and determined that, due to the exercise price protection provision, they should be recorded as derivative liabilities. Marina determined the fair value of the warrants on the issuance date and recorded a liability and a discount of $0.6 million on the Series D Preferred resulting from the allocation of proceeds to the warrants. Marina then determined the effective conversion price of the Series D Preferred which resulted in a beneficial conversion feature of $0.7 million. The beneficial conversion feature was recorded as both a debit and a credit to additional paid-in capital and as a deemed dividend on the Series D Preferred in determining net income applicable to common stock holders in the consolidated statements of operations.

Each share of Series C Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.75 per share. In June 2015, an investor converted 90 shares of Series C Preferred into 600,000 shares of common stock with a value of $0.54 per share. In November 2015, an investor converted an additional 90 shares of Series C Preferred into 600,000 shares of common stock with a value of $0.31 per share. Also in November 2015, an investor converted 50 shares of Series D Preferred into 625,00062,500 shares of common stock with a value of $0.28 per share.  

stock. In February 2016, an investor converted 110 shares of Series D Preferred into 1,375,000137,500 shares of common stock with a value of $0.15 per share.stock.

 

Common Stock

 

Holders of our common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the holders of our common stock. Subject to the rights of the holders of any class of our capital stock having any preference or priority over our common stock, the holders of our common stock are entitled to receive dividends that are declared by our board of directors out of legally available funds. In the event of our liquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in our net assets remaining after payment of liabilities, subject to prior rights of preferred stock, if any, then outstanding. Our common stock has no preemptive rights, conversion rights, redemption rights or sinking fund provisions, and there are no dividends in arrears or default. All shares of our common stock have equal distribution, liquidation and voting rights, and have no preferences or exchange rights. Our common stock currently trades on the OTCQB tier of the OTC Markets.

Stock Issuances

 

In February 2017, we entered into two privately negotiated transactions pursuant to which we issued an aggregate of 6,153,684615,368 shares of our common stock for an effective price per share of $0.29$2.90 to settle aggregate liabilityliabilities of approximately $948,000, which ishad been reflected in accrued expenses as of December 31, 2016.

 

In February 2017, we issued 300,00030,000 shares of our common stock with a fair value of $0.18$1.80 per share to a consultant providing investment advisory services.

 

In February 2017, we issued 100,00010,000 restricted shares of our common stock with a fair value of $0.14$1.40 per share to our CEO for services.

 

OnIn February 6, 2017, we entered into a Stock Purchase Agreement with LipoMedics, a related party, pursuant to which we issued to LipoMedics an aggregate of 862,06886,207 shares of our common stock for a total purchase price of $250,000.

 

OnIn March 31, 2017, we entered into a Settlement Agreement, whereby a note receivable for $45,000 was settled with a cash payment by the note holder to the Company of $14,049, the surrender of 60,0006,000 warrants, and the surrender of 87,2548,725 shares of common stock held by the noteholder, which were cancelled effective March 31, 2017.

 

In April 2017, the Company entered into a Compromise and Release Agreement to settle $36,047 due to a service provider for $15,957 in cash and $20,090 of the Company’s common stock at $2.90 per share (for a total issuance of 6,928 shares). The Company issued 6,928 shares to the service provider in May 2017.

In May 2017, the holders of warrants to purchase 60,944 shares of our common stock at an exercise price of $2.80 per share exercised such warrants, yielding aggregate gross proceeds to us of $170,643.

In June 2017, we entered into an offer letter to hire our current Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective on June 22, 2017. We also agreed in such offer letter to issue 60,000 restricted shares of our common stock under our 2014 Long-Term Incentive Plan to our Chief Commercial Officer, with all of such shares to vest on the six (6) month anniversary of the date of grant. These shares were issued in June 2017.

In August 2017, in connection with the reverse split, we issued 3,360 shares of common stock due to rounding at exchange and participant levels.

In September 2017, an investor converted 270 shares of Series C Preferred stock into 180,000 shares of our common stock on a cashless basis.

Warrants

 

As of March 31,September 30, 2017, there were 27,029,9952,492,945 warrants outstanding, with a weighted average exercise price of $0.43$4.40 per share, and annual expirations as follows:

 

Expiring in 2017  2,100,545- 
Expiring in 2018  113,83111,383 
Expiring in 2019  6,000,000600,000 
Expiring in 2020  11,890,7921,189,079 
Expiring in 2021  3,437,500343,750 
Expiring thereafter  3,487,327348,733 
   27,029,9952,492,945 

On May 21, 2017, the holders of warrants to purchase 60,944 shares of our common stock at an exercise price of $2.80 per share exercised such warrants, yielding aggregate gross proceeds to us of $170,643.

A total of 149,111 warrants expired in May 2017.

 

Note 6 — Stock Incentive Plans

 

Stock Options

 

Stock option activity was as follows:

 

 Options Outstanding  Options Outstanding 
 Shares  Weighted
Average
Exercise Price
  Shares Weighted
Average
Exercise Price
 
Outstanding, December 31, 2016  1,688,106  $3.68   168,811  $36.80 
Options granted  646,000   0.17   64,600   1.70 
Options expired  (106)  526.40   (11)  5,264.00 
Outstanding, March 31, 2017  2,334,000   2.69 
Exercisable, March 31, 2017  1,931,000  $3.21 
Outstanding, September 30, 2017  233,400   26.85 
Exercisable, September 30, 2017  193,100  $32.10 

 

The following table summarizes additional information on Marina’s stock options outstanding at March 31,September 30, 2017:

 

  Options Outstanding  Options Exercisable  Options Outstanding Options Exercisable 

Range of

Exercise
Prices

Range of

Exercise
Prices

  Number
Outstanding
  Weighted-
Average
Remaining
Contractual
Life (Years)
  Weighted
Average
Exercise
Price
  Number
Exercisable
  Weighted
Average
Exercise Price
 

Range of

Exercise
Prices

Number
Outstanding
 Weighted-
Average
Remaining
Contractual
Life (Years)
 Weighted
Average
Exercise
Price
 Number
Exercisable
 Weighted
Average
Exercise Price
 
$0.10   140,000   4.63  $0.10   140,000  $0.10 0.10 14,000   4.30  $1.00   14,000  $1.00 
$0.17 - .018   646,000   4.80   0.17   243,000   0.17 0.17 - .018 64,600   4.13   1.72   24,300   1.70 
$0.26 - 0.82   484,000   3.24   0.46   484,000   0.46 0.26 - 0.82 48,400   2.73   4.62   48,400   4.62 
$1.07 - $2.20   1,021,500   6.24   1.07   1,021,500   1.07 1.07 - $2.20 102,150   5.74   10.73   102,150   10.73 
$47.60 - $87.60   21,000   1.19   67.60   21,000   67.60 47.60 - $87.60 2,100   .69   676.00   2,100   676.00 
$127.60 - $207.60   21,500   1.19   158.30   21,500   158.30 127.60 - $207.60 2,150   .69   1,582.98   2,150   1,582.98 
Totals   2,334,000   5.03  $3.68   1,931,000  $3.21 Totals 233,400   4.53  $26.85   193,100  $32.10 

 

Weighted-Average Exercisable Remaining Contractual Life (Years) 5.084.53

 

In January 2017, the Company granted a total of 486,00048,600 stock options to directors and officers for services. One-half of the options vest immediately and one-half of the options vest on the one yearone-year anniversary of the grant date. The options have an exercise price of $0.17$1.70 and a five-year term.

In February 2017, the Company granted a total of 160,00016,000 stock options to key employees for services. The options vest on the one yearone-year anniversary of the grant date, have an exercise price of $0.18,$1.80, and have a five-year term.

Subsequent to the date of the financial statements, in October 2017, we appointed our Chief Financial Officer and our Chief Legal Officer. In connection with these appointments, we granted to each such officer options to purchase up to 60,000 shares of our common stock under our 2014 Long-Term Incentive Plan, with all of such options vesting and becoming exercisable on the one-year anniversary of the grant date.

At March 31,September 30, 2017, we had $51,901$36,573 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $44,240$59,568 for the threenine months ended March 31,September 30, 2017.

 

At March 31,September 30, 2017, the intrinsic value of options outstanding or exercisable was $99,300$201,100 as there were 1,018,000101,800 options outstanding with an exercise price less than $0.28,$2.80, the per share closing market price of our common stock at that date.

 

Note 7 — Intellectual Property and Collaborative Agreements

 

Novosom Agreements

 

In July 2010, Marina entered into an agreement pursuant to which Marina acquired intellectual property for Novosom’s SMARTICLES-based liposomal delivery system. In February 2016, Marina issued Novosom 0.21 million20,548 shares of common stock valued at $0.06 million.approximately $58,000 as additional consideration under such agreement.

 

In March 2016, Marina entered into a license agreement covering certain of Marina’s platforms for the delivery of an undisclosed genome editing technology. Under the terms of the agreement, Marina received an upfront license fee of $0.25 million$250,000 and could receive up to $40 million in success-based milestones. In April 2016, Marina issued Novosom 0.47 million47,468 shares of common stock valued at $0.075 millionapproximately $75,000 for amounts due under this agreement.

 

In July 2016, Marina entered into a license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. Under the terms of this agreement, the licensee agreed to pay to us an upfront license fee in the amount of $0.35 million$350,000 (to be paid in installments through the end of 2017), along with milestone payments on a per-licensed-product basis and royalty payments in the low single digit percentages. As of September 30, 2016, Marina had received $0.05 million$50,000 per the terms of this license agreement. In November 2016, we issued 0.12 million11,905 shares with a value of $0.015 million$15,000 to Novosom as the equity component owed under Marina’s July 2016 license agreement.

 

Arrangements with LipoMedics

 

OnIn February 6, 2017, we entered into a License Agreement (the “License Agreement”) with LipoMedics, Inc., a related party (“LipoMedics”), pursuant to which, among other things, we provided to LipoMedics a license to our SMARTICLES platform for further development of Lipomedics’s proprietary phospholipid nanoparticles that can deliver protein, small molecule drugs, and peptides. These are not currently being developed at Marina Biotech and Marina Biotech has no IP around these products. On the same date, we also entered into a Stock Purchase Agreement with LipoMedics pursuant to which we issued to LipoMedics an aggregate of 862,06886,207 shares of our common stock for a total purchase price of $250,000.

 

Under the terms of the License Agreement, we could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if LipoMedics determines to pursue further development and commercialization of products under the License Agreement, LipoMedics agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $0.29$2.90 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which LipoMedics notifies us that it intends to pursue further development or commercialization of a licensed product.

 

If LipoMedics breaches the License Agreement, we shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to LipoMedics specifying the breach, if LipoMedics fails to cure such material breach within such sixty (60) day period. LipoMedics may terminate the License Agreement by giving thirty (30) days’ prior written notice to us.

 

Vuong Trieu, Ph.D., theour Executive Chairman, of the Board of Directors of the Company (the “Board”), is the Chairman of the Board and Chief Operating Officer of LipoMedics.

In consideration Lipomedics agreed to the following fee schedule: 1) Evaluations License Fee. Simultaneous with the execution and delivery of thisthe License Agreement, Lipomedics shall enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Lipomedics, pursuant to which Marina will sell to Lipomedics shares of the common stock of Marina for an aggregate purchase price of $250,000,$0.25 million, with the purchase price for each share of Marina common stock being $0.29.$2.90. 2) Commercial License Fee. Unless thisthe License Agreement is earlier terminated, within thirty (30) days following Lipomedics’s delivery of an Evaluation Notice advising that it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products. 3) For up to and including three Licensed Products, Lipomedics shall pay to Marina a milestone (collectively the “Sales Milestones”) of Ten Million Dollars ($10,000,000)$10 million upon reaching Commercial Sales in the Territory in any given twelve month period equal to or greater than Five Hundred Million Dollars ($500,000,000)$500 million for a given Licensed Product and of Twenty Million Dollars ($20,000,000)$20 million upon reaching Commercial Sales in any given twelve month period equal to or greater than One Billion Dollars ($1,000,000,000)$1 million for such Licensed Product, such payments to be made within thirty (30) days following the month in which such Commercial Sale targets are met.

Arrangements with Oncotelic Inc.

In July 2017, we entered into a License Agreement (the “License Agreement”) with Oncotelic, Inc. (“Oncotelic”) pursuant to which, among other things, we provided to Oncotelic a license to our SMARTICLES platform for the delivery of antisense DNA therapeutics, as well as a license to our conformationally restricted nucleotide (“CRN”) technology with respect to TGF-Beta. Under the terms of the License Agreement, Oncotelic also agreed to purchase 49,019 shares of our common stock for an aggregate purchase price of $0.25 million ($5.10 per share), with such purchase and sale to be made pursuant to a Stock Purchase Agreement to be entered into between us and Oncotelic within thirty (30) days following the date of the License Agreement.

Under the terms of the License Agreement, we could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if Oncotelic determines to pursue further development and commercialization of products under the License Agreement, Oncotelic agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $0.5 million, with the purchase price for each share of common stock being the greater of $5.10 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which Oncotelic notifies us that it intends to pursue further development or commercialization of a licensed product.

If Oncotelic breaches the License Agreement, we shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to Oncotelic specifying the breach, if Oncotelic fails to cure such material breach within such sixty (60) day period. Oncotelic may terminate the License Agreement by giving thirty (30) days’ prior written notice to us.

Dr. Trieu, our Executive Chairman, is the principal stockholder and Chief Executive Officer of Oncotelic.

Sale of DiLA2 Assets

In July 2017, we entered into a binding term sheet with a third-party purchaser (“Purchaser”) pursuant to which Purchaser will purchase from us the patents, know-how, agreements, records and certain other assets relating to our DiLA2 delivery system. The consideration to be paid by Purchaser to us as a result of this transaction shall consist of: (i) an initial payment of $0.3 million to be paid upon the closing of the asset sale; and (ii) an additional $1.2 million to be paid upon the first to occur of (x) a financing in which third party investors purchase equity and/or debt securities of Purchaser resulting in aggregate proceeds to Purchaser of not less than $15 million and (y) the twelve-month anniversary of the closing.

The closing of the transaction is subject to the negotiation, execution and delivery of a definitive asset purchase agreement and Purchaser’s determination that its due diligence has been completed and has been found satisfactory, in Purchaser’s sole discretion.

In the term sheet, we agreed that we will negotiate exclusively with Purchaser with respect to the sale of the DiLA2 assets for a period of ninety (90) days from the date of the term sheet. Although this ninety (90) day period has expired according to the term sheet, negotiations are ongoing between us and the Purchaser.

Pursuant to the term sheet, at any time following the closing of the transaction and prior to the payment to us of the additional $1.2 million payment, Purchaser may elect to unwind the transaction by providing written notice to such effect to us. Within thirty (30) days of Purchaser’s issuance of such notice, Purchaser shall assign the DiLA2 assets back to us.

We will retain an exclusive, fully paid and royalty free license to DiLA2 outside of the field of gene editing as well as the rights to license DiLA2 outside of gene editing.

Asset Purchase Agreement

In July 2017, Marina entered into an Asset Purchase Agreement with Symplmed Pharmaceuticals LLC and its wholly-owned subsidiary Symplmed Technologies, LLC pursuant to which the Company purchased from the Sellers, for an aggregate purchase price of $75,000 in cash, certain specified assets of the Sellers relating to the Sellers’ patented technology platform known as DyrctAxess that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care (see Note 2).

 

Note 8 – Commitments and Contingencies

 

LitigationAmendment to Agreement with Windlas Healthcare Private Limited

 

On August 17, 2017, we entered into an amendment (the “Amendment”) of that certain Pharmaceutical Development Agreement dated as of March 30, 2017 by and between Windlas Healthcare Private Limited (“Windlas”) and our company (the “Development Agreement”), relating to the development by Windlas of certain pharmaceutical products to be used for conducting clinical trials or for regulatory submissions, as more fully described therein. Pursuant to the Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas’ agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the total amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). The maximum value of common stock that may be issued to Windlas pursuant to the Development Agreement (as modified by the Amendment) is $2 million. The parties also agreed that the foregoing payment arrangement would apply to any Contract Manufacturing and Supply Agreement (or similar agreement) relating to the manufacturing of commercial batches of the products covered by the Development Agreement that may be entered into between the parties.

Litigation

Because of the nature of the Company’s activities, the Company is subject to claims and/or threatened legal actions, which arise out of the normal course of business. ManagementOther than the disclosure below, as of the date of this filing, the Company is currently not aware of any pending lawsuits.lawsuits against the Company, its officers or directors.

The Company has been named on a complaint filed in New York State as a defendant in the matter entitledVaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. While this complaint has been filed in the Supreme Court of the State of New York, the Company has not been legally served. The complaint alleges, in relevant part, that: (i) the sale by Symplmed Pharmaceuticals, Inc. of its assets related to its Prestalia product, and the sale by Symplmed Technologies, Inc. of its assets related to its DyrctAxess platform, should be set aside pursuant to New York law as they were consummated without fair consideration to the sellers (the “Symplmed Defendants”), and thereby had the effect of fraudulently depriving the creditors of the Symplmed Defendants, including Vaya Pharma, Inc., of funds that could have been used to pay their debts; and (ii) the Company is liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement the Company is only contractually responsible for liabilities that accrue after the parties entered into the agreement for Prestalia and any liabilities that existed prior to the agreement are contractually held by Symplmed. If and when the Company is legally served, it is the intention of the Company to dispute jurisdiction, the sufficiency of the pleading and the claims set forth in this complaint, and to defend this matter, vigorously. However, due to the inherent uncertainties of litigation, the ultimate outcome of this matter is uncertain. An unfavorable outcome could materially and adversely affect the business, financial condition and results of operations of the Company.

 

Note 9 - Subsequent Events

 

On April 13,Except for the event(s) discussed in this Note 9, there were no subsequent events that required recognition or disclosure. The Company evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission.

In September 2017, the Companywe entered into an engagement letter with a Compromise and Release Agreementfinancial advisor pursuant to settle $36,047 duewhich, among other things, we agreed to a service provider for $15,957issue to such financial advisor, in cash and $20,090partial consideration of the Company’sservices to be rendered under the engagement letter, an aggregate of 500,058 shares of our common stock. The shares were issued in November 2017.

In October 2017, we appointed our Chief Financial Officer and our Chief Legal Officer. In connection with these appointments, we granted to each such officer options to purchase up to 60,000 shares of our common stock at $0.29 per share (for a total issuanceunder our 2014 Long-Term Incentive Plan, with all of 69,276 shares). The Company issued 69,276 shares tosuch options vesting and becoming exercisable on the service provider in May 2017.one-year anniversary of the grant date.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward-Looking Statements

 

This report contains forward-looking statements. The following discussion should be read in conjunction with the financial statements and related notes contained in our Annual Report on Form 10-K, as filed with the Securities &and Exchange Commission (“SEC”) on March 31, 2017. Certain statements made in this discussion are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are projections in respect of future events or financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements made in a quarterly report on Form 10-Q may include statements about:

 

our ability to obtain additional and substantial funding for our company on an immediate basis, whether pursuant to a capital raising transaction arising from the sale of our securities, a strategic transaction, debt or otherwise;
otherwise and at terms acceptable to us;
our ability to attract and/or maintain research, development, commercialization and manufacturing partners;
the ability of our company and/or a partner to successfully complete product research and development, including pre-clinical and clinical studies and commercialization;
the ability of our company and/or a partner to obtain required governmental approvals, including product and patent approvals;
the ability of our company and/or a partner to develop and commercialize products that can compete favorably with those of our competitors;
the timing of costs and expenses related to the research and development programs of our company and/or our partners;
the timing and recognition of revenue from milestone payments and other sources not related to product sales;
our ability to obtain suitable facilities in which to conduct our planned business operations on acceptable terms and on a timely basis;
our ability to satisfy our disclosure obligations under the Securities Exchange Act of 1934, as amended, and to maintain the registration of our common stock thereunder;
our ability to attract and retain qualified officers, employees and consultants as necessary; and
the costs associated with any product liability claims, patent prosecution, patent infringement lawsuits and other lawsuits.

 

These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities & Exchange CommissionSEC on March 31, 2017, any of which may cause our company’s or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks may cause the Company’s or its industry’s actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The Company isWe are under no duty to update any forward-looking statements after the date of this report to conform these statements to actual results.

 

As used in this quarterly report and unless otherwise indicated, the terms “we,” “us,” “our” or the “Company” refer to Marina Biotech, Inc., a Delaware corporation.corporation, and its wholly-owned subsidiaries, , MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and Atossa HealthCare, Inc.; and IThenaPharma Inc. Unless otherwise specified, all dollar amounts are expressed in United States dollars. Our common stock is currently listed on the OTC Market, OTCQB tier, under the symbol “MRNA”.“MRNA.”

Corporate Overview

 

We are a fully integrated, commercial stage biopharmaceutical company engaged in the discovery, acquisition, development and commercialization ofdelivering proprietary drug therapeutics for addressing significant unmet medical needs in the U.S., Europe and certain additional international markets. Our primary therapeutic focus is the disease intersectionportfolio of products currently focuses on fixed dose combinations (“FDC”) in hypertension, arthritis, pain and oncology allowing for innovative solutions to such unmet medical needs. Our mission is to provide effective and patient centric treatment for hypertension – including resistant hypertension. In this connection, we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the innovative combination therapies from already approvedintellectual property assets related to the patented technology platform known as DyrctAxess, also called Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care.

In doing so, we have created a universal platform for the effective treatment of hypertension as well as for the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, and the proprietary novel oligotherapeutics of Marina Biotech, Inc. (“Marina”). Our approach is meant to reduce the risk associated with developing a new drug and to also accelerate the time to commercialization by shortening the clinical development program through leveraging what is already known or can be learnedother products in our proprietary Patient Level Database (“PLD”).pipeline, devices for therapeutic drug monitoring, blood pressure, and other cardiac monitors, as well as services such as counseling and prescription reminders.

 

We currently have one commercial and three clinical development programs underway includingunderway: (i) Prestalia®, a single-pill fixed dose combination of perindopril, an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine, a calcium channel blocker (“CCB”), which has been approved by the U.S. Food and Drug Administration (“FDA”) and is actively marketed in the U.S.; (ii) our next generation celecoxib program drug candidates for the treatment of acute and chronic pain, IT-102 and IT-103, each of which is a fixed dose combinationan FDC of celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (“NSAID”) and either lisinopril (IT-102) or olmesartan (IT-103), (ii) – both Lisinopril and olmesartan are antihypertension drugs; (iii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication of Familial Adenomatous Polyposis (“FAP”); and (iii)(iv) CEQ508 combined with IT-103 to treat Colorectal Cancer (“CRC”).Cancer.

 

Our preclinical pipeline also includes oligotherapeutics for bladder cancer, Inflammatory Bowel Disease (“IBD”),current focus is primarily on the commercialization of Prestalia and Duchenne Muscular Dystrophy. Preclinical proofsecondarily the development of concept studies haveIT-102 and IT-103. We believe that by combining a COX-2 inhibitor with an antihypertensive in a single FDC oral tablet, IT-102 and IT-103 will each offer improved safety profiles as compared to currently available and previously marketed COX-2 inhibitors as well as address patients with chronic pain who are commonly taking antihypertension drugs concurrently. We further believe that the current opioid addiction epidemic in the U.S. has been completeddriven in part by the withdrawal from the market of certain COX-2 inhibitors due to their associated risk of cardiovascular-related adverse events. We plan to license or divest our other assets since they no longer align with respect to bladder cancer and IBD.our focus on the treatment of hypertension.

 

Although weWe intend to create value through the continued commercialization of our FDA-approved product, Prestalia, while moving our FDC development programs forward to further strengthen our commercial presence. We intend to retain ownership and control of all of our product candidates, by advancing their development,but in the interest of accelerated growth and market penetration, we will also consider partnerships with pharmaceutical or biopharmaceuticalbiotechnology companies in order to reduce time to market and to balance thedevelopment risks, associated with drug discoveryboth clinically and development, thereby maximizing our stockholders’ value. Our partnering objectives include generating revenue through license fees, milestone-related development fees and royalties by licensing rights to our product candidates, which would be a source of non-dilutive capital.financially.

 

We may engage in licensing activities associated with our delivery platforms (SMARTICLES andtkRNAi). However, sinceAs our strategy is to be a late-stagefully integrated biopharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, with the goal of a secondary focus on advancing our FDC pipeline to further enhance our commercial product launch and profitability within the next several years, the development and licensing of these platforms for the therapeutic assets of third parties will not be the primary focus of our company.presence.

 

Background and Corporate Developments

Reverse Merger with IThenaPharma

 

On November 15, 2016, Marina entered into an Agreement and Plan of Merger with IThenaPharma, Inc., a Delaware corporation (“IThena” or “IThenaPharma”), IThena Acquisition Corporation, a Delaware corporation and a wholly-owned subsidiary of IThena (“Merger Sub”), and Vuong Trieu, Ph.D. as the IThena Representative (the “Merger Agreement”), pursuant to which, among other things, Merger Sub merged with and into IThena, with IThena surviving as a wholly owned subsidiary of Marina (such transaction, the “Merger”). Pursuant to the Merger Agreement, at the effective time of the Merger, without any action on the part of any shareholder, each issued and outstanding share of IThenaPharma’s common stock, other than shares to be cancelled pursuant to the Merger Agreement, was converted into the right to receive 10.510708 shares of Marina common stock (the “Exchange Ratio”). IThenaPharma shareholders were not entitled to receive fractional shares in the Merger. Instead, a holder of IThenaPharma’s common stock that would otherwise have been entitled to receive a fractional share of Marina common stock in the Merger received one full additional share of Marina common stock. In addition, in connection with the Merger, each outstanding IThenaPharma warrant was assumed by Marina and converted into a warrant representing the right to purchase shares of Marina common stock, with the number of shares underlying such warrant and the exercise price thereof being adjusted by the Exchange Ratio, with any fractional shares rounded down to the next lowest number of whole shares. As a result of the Merger, the former holders of IThenaPharma common stock immediately prior to the completion of the Merger owned approximately 65% of the issued and outstanding shares of Marina common stock immediately following the completion of the Merger.

Marina was incorporated under the laws of the State of Delaware under the name Nastech Pharmaceutical Company on September 23, 1983, and IThena was incorporated under the laws of the State of Delaware on September 3, 2014. On November 15, 2016, Marina entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among Marina, IThenaPharma Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). IThena is deemed to be the accounting acquirer in the Merger, and thus the historical financial statements of IThena are treated as the historical financial statements of our company and are reflected in our quarterly and annual reports for periods ending after the effective time of the Merger, or November 15, 2016. Accordingly, beginning with our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as filed with the Securities & Exchange CommissionSEC on March 31, 2017, we have reported the results of IThena and Marina and their respective subsidiaries on a consolidated basis.

Autotelic LLC License Agreement

In connection with the Merger Agreement and the closing of the Merger, on November 15, 2016, Marina entered into a License Agreement with Autotelic LLC (the “License Agreement”), a stockholder of IThenaPharma that became the holder of 23,123,558 shares of Marina common stock as As a result of the Merger, while we have presented the results for the three and an entitynine periods ended September 30, 2017 and 2016, the results for the 2016 periods reflect only the results of IThena.

IThena is a developer of personalized therapies for combined pain/hypertension through its proprietary FDC technology and point of care Therapeutic Drug Monitoring system (“TDM”). Through the combination of these technologies, IThena is looking to deliver therapies with improved compliance and personalized dosing. IThena’s lead products are the celecoxib FDCs which Dr. Trieu, the Chairman of our Board of Directors (the “Board) serves as Chief Executive Officer, pursuant to which (i) Marina licensed to Autotelic LLC certain patent rights, data and know-how relating to FAP and nasal insulin, for human therapeutics other than for oncology-related therapies and indications, and (ii) Autotelic LLC licensed to Marina certain patent rights, data and know-how relating toinclude IT-102 and IT-103, in connectionFDCs of celecoxib and lisinopril and celecoxib and olmesartan, respectively. IT-102 and IT-103 are being developed as celecoxib without the drug induced edema associated with individualized therapycelecoxib alone. IT-102 and IT-103 are being developed initially for pain using a non-steroidal anti-inflammatory drugcombined arthritis / hypertension and an anti-hypertensive without inducing intolerable edema, andsubsequently for treatment of certain aspectspain, or cancer, or other indications requiring high doses of proliferative disease, but not including rights to IT-102/IT-103 for TDM guided dosing for all indications using an Autotelic LLC TDM Device. Marina also granted a right of first refusal to Autotelic LLC with respect to any license by Marina of the rights licensed by or to Marina under the License Agreement in any cancer indication outside of gastrointestinal cancers.

The License Agreement shall immediately terminate, all rights granted by a licensor under the License Agreement shall immediately revert forthwith to the applicable licensor, all benefits which have accrued under the License Agreement shall automatically be transferred to the applicable licensor, and all rights, title and interest in the licensed intellectual property shall immediately revert back to the applicable licensor if: (i) the applicable licensee makes a general assignment for the benefit of its creditors prior to the two (2) year anniversary of the date of the License Agreement; (ii) the applicable licensee applies for or consents to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of its intellectual property prior to the two (2) year anniversary of the date of the License Agreement; (iii) prior to the two (2) year anniversary of the date of the License Agreement, and without the consent of the applicable licensor, the applicable licensee effects a Change of Control Transaction (as defined in the License Agreement); (iv) the applicable licensee ceases operations; or (v) the applicable licensee fails to take any material steps, as reasonably determined by the applicable licensor, to develop the licensed intellectual property prior to the one (1) year anniversary of the date of the License Agreement (each of the foregoing items (i) through (v), a “Termination Event”). Upon the occurrence of any Termination Event, the applicable licensee shall immediately discontinue all use of the licensed intellectual property.celecoxib.

 

Master Services AgreementAcquisition of Prestalia

 

In connectionSubsequent to the Merger we executed on our strategy to become a commercial stage company with the Merger Agreement and the closingacquisition of the Merger,Prestalia from Symplmed. Specifically, on November 15, 2016, MarinaJune 6, 2017 we entered into a Master Servicesan Asset Purchase Agreement with Autotelic Inc.Symplmed for the purchase of Prestalia, which is an FDA-approved and marketed anti-hypertensive drug. This is a FDC of perindopril arginine, an ACE inhibitor, and amlodipine besylate, a calcium channel blocker (“Autotelic”CCB”), a stockholder of IThenaPharma that became the holder of 5,255,354 shares of Marina common stockand is indicated as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board, pursuant to which Autotelic agreed to provide certain business functions and services from time to time during regular business hours at Marina’s request (the “Master Services Agreement”). The Master Services Agreement has a term of ten years, though either party can terminate it by giving to the other party ninety (90) days’ prior written notice of such termination (providedfirst line therapy for hypertension control.

We believe that the final dayacquisition of Prestalia transforms our company from a clinical stage company to a commercial organization. Prestalia was approved in January 2015 and has been marketed in select U.S. states since then by Symplmed. Prestalia sales saw solid growth through September of 2016, via new patient acquisition and strong patient retention. Due to lack of funding, further revenues and marketing of Prestalia was ceased by the end of calendar year 2016. In the near term shallour focus will be ondedicated to re-acquiring prior Prestalia patients, with subsequent efforts dedicated to building a strong sales team to fully market the last day of the calendar month in which the noticed termination date falls). The resources availableproduct. This includes our efforts to Marina through Autotelic include, without limitation, regulatory, clinical, preclinical, manufacturing, formulation, legal, accounting and information technology.re-establish our relationships with our contract manufacturers to support marketing Prestalia.

 

As partial considerationWe believe that the Prestalia acquisition will not only make us a revenue-stage company, but also that the marketing, distribution and sales network that we will build will pave a strong foundation for the services to be performed by Autotelic under the Master Services Agreement, during the period prior to the date on which we have completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10 million, we shall issue to Autotelic warrants to purchase sharespromotion and commercialization of our common stock (the “MSA Warrants”), with the number of shares of common stock for which such MSA Warrants are exercisable,two other hypertension pipeline products – namely IT-102 and the exercise price for such MSA Warrants, being based on the closing price of our common stock; provided, that in no event shall such price be lower than the lower of (x) $0.28 per share or (y) the lowest exercise price of any warrants that have been issued by us in a capital raising transaction (and that would otherwise reduce the exercise price ofIT-103, as well as any other outstanding warrants issued by us) during the period beginning on November 15, 2016 and ending on the date of the issuance of the MSA Warrants.similar products that we internally develop or acquire.

Line LetterLetters with Dr. TrieuRelated Parties

 

In connection with the Merger, Marina entered into a line of credit dated November 15, 2016 with Dr. Trieu, our Executive Chairman, of the Board, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses (“Line Letter”). Dr. Trieu will consider requests for advances under the Line Letter until April 30, 2017. As of March 31,September 30, 2017, Dr. Trieu has advanced an aggregate of $475,064$540,00 under the Line Letter. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by a demand promissory note issued to Dr. Trieu, and are due and payable upon demand by Dr. Trieu.

 

On April 4, 2017, we entered into a Line Letter with Autotelic for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses. Autotelic was to consider requests for advances under the Line Letter until September 1, 2017. The Company and Autotelic Inc. are in discussions to extend this line letter through December 31, 2017. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissory Note issued to Autotelic, and are due and payable upon demand by Autotelic. We currently have approximately $407,000 of available funds under this line of credit. We believe that this available cash is sufficient to fund our operations through December 31, 2017.

Recent Developments During the Three Months Ended March 31,September 30, 2017

 

ClinicalAmendment of Notes and IP Developments

On January 3, 2017, we announced that the Company was granted a patent for Bacteria Mediated Gene Silencing (EP 08768475.9, European Patent 2173875) claims by the European Patent Office. The granted claims relate to the Company’stkRNAi technology that is being utilized in its CEQ508 program for the treatment of FAP.

Our clinical data from our CEQ508 Phase 1 trial for the treatment of FAP met its primary and secondary endpoints of safety and efficacy for CEQ508. The data demonstrated “safety and statistically significant Catenin Knockdown for Cohort 2 along the Duodenum and Ileum.” We intend to continue clinical development of CEQ508 in combination with IT-102, which was acquired in the recent merger with IthenaPharma.

Officer Appointments and Employment AgreementsWarrants

 

On February 2,July 3, 2017, we entered into an employment letteramendment agreement (the “Employment Letter”“Amendment Agreement”) with Joseph W. Ramelli,respect to those certain promissory notes in the Chief Executive Officeraggregate principal amount of $300,000 (each a “Note” and collectively the Company. Pursuant“Notes”) that we issued to the Employment Letter, Mr. Ramelli shall continue to serve as the Chief Executive Officer of the Companytwo accredited investors (the “Purchasers”) pursuant to that certain Note Purchase Agreement dated June 20, 2016 by and among us and the termsPurchasers (the “Purchase Agreement”), and conditions set forth therein. He shall receive a monthly base salary of $10,000, and he also will be entitled to receive a discretionary bonus as determined by the Board of Directors of the Company in its sole discretion. In connection with the Employment Letter, we granted to Mr. Ramelli 100,000 restricted shares of common stock under our 2014 Long-Term Incentive Plan, which shares vested upon our entry into a License Agreement with Lipomedics Inc.

On February 10, 2017, our Board of Directors approved the appointment of Larn Hwang, Ph.D. to serve as our Chief Scientific Officer, effective February 13, 2017. In connection with such appointment, we entered into an employment letter (the “Hwang Letter”) with Dr. Hwang pursuant to which, as compensation for such service, Dr. Hwang will receive an annual base salary of $85,000, and she also will be entitled to receive a discretionary bonus as determined by the Board in its sole discretion. We also granted to Dr. Hwang optionsthose certain warrants to purchase up to 60,000an aggregate of 951,263 shares of our common stock under our 2014 Long-Term Incentive Plan at an exercise pricethat were originally issued pursuant to that certain Note and Warrant Purchase Agreement dated as of $0.18 per share, with all of such options to vestFebruary 10, 2012 by and among the Company, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and the purchasers identified on the one year anniversarysignature pages thereto (as amended from time to time), that are currently held by the Purchasers, and that were amended concurrently with the Purchase Agreement to, among other things, extend the price protection with respect to dilutive offerings afforded thereunder to June 19, 2017 (such warrants, as so amended, the “Amended Prior Warrants”).

Pursuant to the Amendment Agreement, among other things: (i) the maturity date of the Hwang Letter.Notes was extended from June 20, 2017 to December 31, 2017; (iii) the Purchasers agreed, upon the closing of any financing transaction yielding aggregate gross proceeds to us of not less than $3 million that occurs while the Notes are outstanding (any such financing transaction, the “Qualifying Financing Transaction”), to convert the outstanding principal balance and any accrued interest thereon into the securities of our company to be issued and sold at the closing of the Qualifying Financing Transaction at the most favorable price and terms at which our securities are sold to investors in the Qualifying Financing Transaction; (iv) the parties agreed to extend the price protection with respect to the Amended Prior Warrants resulting from dilutive issuances until the expiration of the term of the Amended Prior Warrants (currently February 10, 2020); provided, that such protection shall not apply to the Qualifying Financing Transaction; and (v) we agreed to issue to the Purchasers, on a pro rata basis, such number of our securities as are being issued to investors in the Qualifying Financing Transaction as have an aggregate purchase price equal to $375,000.

 

On February 10, 2017, our Board of Directors approved the appointment of Mihir Munsif to serve as our Chief Operating Officer, effective February 13, 2017. In connectionArrangements with such appointment, we entered into an employment letter (the “Munsif Letter”) with Mr. Munsif pursuant to which, as compensation for such service, Mr. Munsif will receive an annual base salary of $65,000, and he also will be entitled to receive a discretionary bonus as determined by the Board in its sole discretion. We also granted to Mr. Munsif options to purchase up to 60,000 shares of our common stock under our 2014 Long-Term Incentive Plan at an exercise price of $0.18 per share, with all of such options to vest on the one year anniversary of the Munsif Letter.

On February 21, 2017, we appointed Seymour Fein MD as our Chief Medical Officer. Having taken more than twenty drugs from development on through FDA approval, Dr. Fein is in a unique position to lead the regulatory and clinical development of our pipeline.

Lipomedics License AgreementOncotelic Inc.

 

On February 6,July 17, 2017, the Companywe entered into a License Agreement (the “License Agreement”) with LipoMedics,Oncotelic, Inc., a related party (“LipoMedics”Oncotelic”), pursuant to which, among other things, the Companywe provided to LipoMedicsOncotelic a license to the Company’sour SMARTICLES platform for further developmentthe delivery of Lipomedics’s proprietary phospholipid nanoparticles that can deliver protein, small molecule drugs,antisense DNA therapeutics, as well as a license to our conformationally restricted nucleotide (“CRN”) technology with respect to TGF-Beta. Under the terms of the License Agreement, Oncotelic also agreed to purchase 49,019 shares of our common stock for an aggregate purchase price of $250,000 ($5.10 per share), with such purchase and peptides. These are not currently being developed at Marina Biotechsale to be made pursuant to a Stock Purchase Agreement to be entered into between us and Marina Biotech has no IP around these products.Oncotelic within thirty (30) days following the date of the License Agreement.

 

Under the terms of the License Agreement, the Companywe could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if LipoMedicsOncotelic determines to pursue further development and commercialization of products under the License Agreement, LipoMedicsOncotelic agreed, in connection therewith, to purchase shares of the Company’sour common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $0.29$5.10 or the volume weighted average price of theour common stock for the thirty (30) trading days immediately preceding the date on which LipoMedicsOncotelic notifies the Companyus that it intends to pursue further development or commercialization of a licensed product.

 

If LipoMedics breachesDr. Trieu, our Executive Chairman, is the License Agreement,principal stockholder and Chief Executive Officer of Oncotelic.

Sale of DiLA2 Assets

On July 21, 2017, we entered into a binding term sheet with a third-party purchaser (the “Purchaser”) pursuant to which the CompanyPurchaser will purchase from us the patents, know-how, agreements, records and certain other assets relating to our DiLA2delivery system. The consideration to be paid by Purchaser to us as a result of this transaction shall haveconsist of: (i) an initial payment of $300,000 to be paid upon the rightclosing of the asset sale; and (ii) an additional $1.2 million to terminatebe paid upon the License Agreement effective sixty (60)first to occur of (x) a financing in which third party investors purchase equity and/or debt securities of Purchaser resulting in aggregate proceeds to Purchaser of not less than $15 million and (y) the twelve-month anniversary of the closing.

The closing of the transaction is subject to the negotiation, execution and delivery of a definitive asset purchase agreement and Purchaser’s determination that its due diligence has been completed and has been found satisfactory, in Purchaser’s sole discretion.

We agreed that we will negotiate exclusively with Purchaser with respect to the sale of the DiLA2 assets for a period of ninety (90) days from the date of the term sheet. Although this ninety (90) day period has expired according to the term sheet, negotiations are ongoing between us and the Purchaser. Pursuant to the term sheet, at any time following deliverythe closing of the transaction and prior to the payment to us of the additional $1.2 million payment, Purchaser may elect to unwind the transaction by providing written notice to LipoMedics specifying the breach, if LipoMedics failssuch effect to cure such material breach within such sixty (60) day period. LipoMedics may terminate the License Agreement by givingus. Within thirty (30) days’ prior writtendays of Purchaser’s issuance of such notice, Purchaser shall assign the DiLA2 assets back to the Company.

Vuong Trieu, Ph.D., the Chairman of our Board of Directors, is the Chairmanus. We will retain an exclusive, fully paid and royalty free license to DiLA2 outside of the Board and Chief Operating Officerfield of LipoMedics.gene editing as well as the rights to license DiLA 2 outside of gene editing.

 

IssuancesAcquisition of Equity Securities and Autotelic Line LetterDyrctAxess Platform

 

On February 6,July 21, 2017, the Companywe entered into a Stockan Asset Purchase Agreement (the “Purchase Agreement”) with LipoMedics,Symplmed Pharmaceuticals LLC (“Symplmed Pharma”) and its wholly-owned subsidiary Symplmed Technologies, LLC (“Symplmed Tech”, and together with Symplmed Pharma, each as “Seller” and together the “Sellers”) pursuant to which we purchased from the Company issued to LipoMedicsSellers, for an aggregate of 862,068 shares of the common stock of the Company for a total purchase price of $250,000 ($0.29 per share).$75,000 in cash, certain specified assets of the Sellers relating to the Sellers’ patented technology platform known as DyrctAxess that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care. The parties entered into the Purchase Agreement in furtherance of the obligations of Symplmed Pharma pursuant to that certain Asset Purchase Agreement dated as of June 5, 2017 between the Company and Symplmed Pharma pursuant to which, among other things, the Company acquired the assets of Symplmed Pharma relating to Prestalia.

Reverse Stock Split

 

On February 6,August 1, 2017, we filed a Certificate of Amendment of our Amended and February 8, 2017, the Company entered into two privately negotiated transactions pursuantRestated Certificate of Incorporation to which it committed to issue an aggregateeffect a one-for-ten reverse split of approximately 6.15 millionour issued and outstanding shares of itscommon stock. Our common stock for an effective price per sharecommenced trading on the OTCQB tier of $0.29 per share. Asthe OTC Markets on a split-adjusted basis on Thursday, August 3, 2017. There was no change to the authorized shares of our common stock as a result of such transactions, the Company reducedreverse split. No fractional shares were issued in connection with the aggregate amountreverse split; any fraction of its outstanding payablesa share of common stock that would otherwise have resulted from the reverse split was rounded up to certain service providers by approximately $1.78 million.the nearest whole share of common stock.

Amendment to Agreement with Windlas Healthcare Private Limited

 

On April 4,August 17, 2017, the Companywe entered into an agreement with Autotelic Inc.amendment (the “Amendment”) of that certain Pharmaceutical Development Agreement dated as of March 30, 2017 by and between Windlas Healthcare Private Limited (“Windlas”) and our company (the “Development Agreement”), pursuant to which Autotelic Inc. offeredrelating to the Company an unsecured linedevelopment by Windlas of credit in an amount not to exceed $500,000,certain pharmaceutical products to be used for current operating expensesconducting clinical trials or for regulatory submissions, as more fully described therein. Pursuant to the Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas’ agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the Companytotal amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). The maximum value of common stock that may be issued to Windlas pursuant to the Development Agreement (as modified by the Amendment) is $2 million. The parties also agreed that the foregoing payment arrangement would apply to any Contract Manufacturing and Supply Agreement (or similar agreement) relating to the manufacturing of commercial batches of the products covered by the Development Agreement that may be entered into between the parties.

Sale of Smarticles Assets

On September 8, 2017, we entered into an Intellectual Property Purchase Agreement (the “Line Letter”“IP Purchase Agreement”) with Novosom Verwaltungs GmbH (“Novosom”) pursuant to which we sold to Novosom substantially all of our intellectual property estate relating to our Smarticles delivery technology (the “Smarticles IP”). Autotelic Inc. will consider requestsWe previously acquired such Smarticles IP from Novosom pursuant to that certain Asset Purchase Agreement dated July 27, 2010 between us and Novosom (the “Original Purchase Agreement”). Following the date of the Original Purchase Agreement, we entered into certain agreements with third parties pursuant to which we provided to such third parties certain licenses and rights with respect to the Smarticles IP (the “License Agreements”).

As per the IP Purchase Agreement, Novosom paid to us $1.00 in cash, and thereafter we shall no longer be responsible for advancesthe ongoing costs of maintaining the Smarticles IP. In addition, the parties agreed that we would retain rights to any future payments that may be due to us from licensees pursuant to the License Agreements, including milestone and royalty payments, if any, and Novosom agreed to relinquish any rights that it may have under the LineOriginal Purchase Agreement to any portion of such payments.

Appointment of Executive Officers

On October 2, 2017, we entered into an Offer Letter until September 1, 2017. Autotelic Inc.with Amit Shah pursuant to which Mr. Shah shall have the right at anyserve as our Chief Financial Officer, and on October 12, 2017, we entered into an Offer Letter with Peter D. Weinstein, Ph.D., J.D. pursuant to which Dr. Weinstein shall serve as our Chief Legal Officer, in each case effective immediately. We agreed to pay a base salary of $120,000 per year to Mr. Shah and a base salary of $150,000 per year to Dr. Weinstein. It is anticipated that each of Mr. Shah and Dr. Weinstein will devote approximately 50% of his business time for any reason in its sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice to the Company or any other person; provided, that Autotelic Inc. agreed that itperformance of his duties for the Company. Each such officer shall be shall be entitled to receive a discretionary bonus as determined by our Board of Directors in an amount up to 40% of such officer’s base salary. Our obligations to make the foregoing payments shall not demandbecome effective unless and until the repaymentclosing of any advances that are madea single capital raising transaction involving the issuance by us of our equity (or equity-linked) securities yielding aggregate gross proceeds to the Company under the Line Letterus of not less than $5 million on or prior to December 31, 2017. We also granted to each such officer options to purchase up to 60,000 shares of our common stock at an exercise price of $2.70 per share (with respect to Mr. Shah) and $2.40 per share (with respect to Dr. Weinstein) under our 2014 Long-Term Incentive Plan, with all of such options vesting and becoming exercisable on the earlier of: (i) October 1, 2017; and (ii) the date on which (x) the Company makes a general assignment for the benefit of its creditors, (y) the Company applies for or consents to the appointment of a receiver, a custodian, a trustee or liquidator of all or a substantial part of its assets or (z) the Company ceases operations. Advances made under the Line Letter shall bear interest at the rate of five percent (5%) per annum, shall be evidenced by a demand promissory note issued by the Company to Autotelic Inc., and shall be due and payable upon demand by Autotelic Inc. Autotelic Inc. is a stockholderone-year anniversary of the Company, and an entity of which Dr. Trieu, the Chairman of the Board of the Company, serves as Chairman of the Board.

Results of Operationsgrant date.

 

Results of Operations

Comparison of the Three Months Ended March 31,September 30, 2017 to the Three Months Ended March 31, 2016September 30, 2017

 

Our loss before income taxes for the three months ended March 31,September 30, 2017 is summarized as follows in comparison to the three months ended March 31,September 30, 2016. As a result of the November 2016 Merger with IThena, the results of operations for the three months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the three months ended September 30, 2016 include only the results of IThena.

  Three Months Ended 
  September 30, 2017  September 30, 2016 
Revenues $-  $- 
Research and development  232,896   50,683 
General and administrative expenses  680,063   47,065 
Amortization  123,038   - 
Other income (expense), net  63,813   (378)
Loss before provision for income taxes $(972,184) $(98,126)

Revenues

We had no revenues in the three months ended September 30, 2017 or 2016. The majority of our licensing deals provide for clinical and regulatory milestones, so significant revenues could result from the existing licenses, but are uncertain as to timing or probability. We will continue to seek research and development collaborations as well as licensing transactions to fund business operations.

27

Expenses

Our expenses for the three months ended September 30, 2017 are summarized as follows in comparison to our expenses for the three months ended September 30, 2016. As stated above, as a result of the November 2016 Merger with IThena, the results of operations for the three months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the three months ended September 30, 2016 include only the results of IThena:

Research and Development

Research and development (“R&D”) expense increased by $182,213, as compared to the three months ended September 30, 2016, primarily due to costs related to the MSA with Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $96,151, on a non-cash basis, through the issuance of warrants valued at $96,151. Other R&D expenses consist of costs of sublicensing fees, clinical development, pre-clinical studies, consulting, other outside services, and other costs.

General and Administrative

General and administrative (“G&A”) expense increased by $632,998 for the three months ended September 30, 2107, as compared to the three months ended September 30, 2016, primarily due to personnel costs of $192,676 and costs related to the MSA with Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $46,859, on a non-cash basis, through the issuance of warrants valued at $46,859. Other G&A expenses consisted of legal costs of approximately $176,000, accounting and auditing fees of approximately $50,000, approximately $56,000 for board member fees and approximately $37,000 for insurance costs. No similar expenses were recorded during the three months ended September 30, 2016. 

Amortization Expense

Amortization expenses relates to amortization of intangible assets acquired in the November 15, 2016 merger and the asset purchases on June 5, 2017 and July 21, 2017, with a combined estimated fair value of $3,056,066.

Other Income (Expense)

  Three Months Ended 
  September 30, 2017  September 30, 2016 
Interest expense $(24,301) $(378)
Change in fair value liability of warrants  7,442   - 
Change in fair value of derivative liability  80,672   - 
Total other expense, net $63,813  $(378)

Total net other expense for the three months ended September 30, 2017 increased $64,191 compared to the three months ended September 30, 2016. The increase is primarily attributable to a decrease in the estimated fair value of price adjustable warrants and the derivative liability of approximately $7,000 and $81,000, respectively, partially offset by an increase in interest expense of $24,000 on notes payable assumed in the Merger.

The fair value liability is revalued each balance sheet date utilizing probability-weighted Black-Scholes computations, with the decrease or increase in fair value being reported in the statement of operations as other income or expense, respectively.

Comparison of the Nine Months Ended September 30, 2017 to the Nine Months Ended September 30, 2016

As a result of the Merger with IThena, the results of operations for the nine months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the nine months ended September 30, 2016 include only the expenses of IThena. Our loss before income taxes for the nine months ended September 30, 2017 is summarized as follows in comparison to the nine months ended September 30, 2016:

 

 Three Months Ended  Nine Months Ended 
 March 31, 2017 March 31, 2016  September 30, 2017 September 30, 2016 
Revenues $-  $-  $-  $- 
Personnel expenses  306,922   83,982 
Research and development  73,431   4,978   746,221   107,910 
General and administrative expenses  1,878,301   232,469 
Amortization  98,378   -   327,642   - 
General and administrative expenses  488,522   25,231 
Other income (expense), net  (114,725)  -   (273,191)  (378)
Loss before provision for income taxes $(1,082,778) $(114,191) $(3,225,355) $(340,757)

 

Revenues

 

We had no in revenuerevenues in the threenine months ended March 31,September 30, 2017 or 2016. The majority of our licensing deals provide for clinical and regulatory milestones, so significant revenues could result from the existing licenses, but are uncertain as to timing or probability. We will continue to seek research and development collaborations as well as licensing transactions to fund business operations.

 

Expenses

 

Our expenses for the threenine months ended March 31,September 30, 2017 are summarized as follows in comparison to our expenses for the threenine months ended March 31, 2016:

Personnel Expenses

Personnel expenses consists primarily of costs related to the Master Services Agreement with Autotelic Inc., a stockholder of IThenaPharma, that became the holder of 5,255,354 shares of Marina common stock asSeptember 30, 2016. As a result of the November 2016 Merger and an entitywith IThena, the results of which Dr. Trieu serves as Chairman of the Board, pursuant to which Autotelic Inc. agreed to provide certain business functions and services from time to time during regular business hours at Marina’s request. We pay Autotelic Inc. for their services with both cash and through the issuance of warrants. Personnel expenses increased $229,940operations for the three months ended March 31, 2107, as compared toSeptember 30, 2017 include the operating expenses of Marina and IThena while the results for the three months ended March 31,September 30, 2016 due to increased useinclude only the results of Autotelic Inc.’s services.IThena.

 

Research and Development

 

Research and development (“R&D”) expense consistsincreased by $638,311, as compared to the nine months ended September 30, 2016, primarily due to costs related to the MSA with Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $245,255 and, on a non-cash basis, through the issuance of warrants valued at $245,255. Other R&D expenses consist of costs of sublicensing fees, clinical development, and pre-clinical studies, consulting, and other outside services, and other costs. R&D

General and Administrative

General and administrative (“G&A”) expense increased $68,453 primarily due toby $1,645,832 for the use of additional R&D consulting during the threenine months ended March 31, 2017,September 30, 2107, as compared to the threenine months ended March 31,September 30, 2016, primarily due to personnel costs and costs related to the MSA with Autotelic Inc., where the Company pays Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $141,699 and, on a non-cash basis, through the issuance of warrants valued at $141,699. Other G&A expenses consisted of legal costs of approximately $540,000, accounting and auditing fees of approximately $194,000, approximately $169,000 for board member fees and approximately $97,000 for insurance costs. No similar expenses were recorded during the nine months ended September 30, 2016.

 

Amortization Expense

 

Amortization expenses relates to amortization of intangible assets acquired in the November 15, 2016 merger,Merger and the asset purchases on June 5, 2017 and July 21, 2017, with ana combined estimated fair value of $2,361,066 amortized over its estimated useful life of six years.

General and Administrative Expenses

  Three Months Ended 
  March 31, 2017  March 31, 2016 
Directors’ fees $56,250  $- 
Accounting and audit fees  69,874   - 
Legal fees  244,808   - 
Insurance  30,100   - 
Other general and administrative expenses  87,491   25,231 
Total $488,522  $23,231 

General and administrative (“G&A”) expense consists primarily of salaries and other personnel-related expenses to support our R&D activities, stock-based compensation for G&A personnel and non-employee members of our Board, professional fees, such as accounting and legal, and corporate insurance costs. G&A costs increased $463,291 primarily since the results of the three months ended March 31, 2017 include the operating expenses of Marina and IThena as a result of the November 15, 2017 merger, while the results for the three months ended March 31, 2016 include only the G&A expenses of IThena.$3,056,066.

 

Other Income (Expense)

 

 Three Months Ended  Nine Months Ended 
 March 31, 2017 March 31, 2016  September 30,2017 September 30, 2016 
Interest expense $(11,653) $-  $(51,575) $(378)
Change in fair value liability of warrants  (103,072)  -   (106,345)  - 
Change in fair value of derivative liability  (115,271)  - 
Total other expense, net $(114,725) $-  $(273,191) $(378)

 

Total net other expense for the threenine months ended March 31,September 30, 2017 increased $114,725$272,813 compared to the threenine months ended March 31,September 30, 2016. The increase is primarily attributable to interest expense on notes payable acquired in the November 15, 2016 merger, and an increase in the estimated fair value of price adjustable warrants partially offset by a gainand derivative liability and interest expense on notes payable acquired in the settlement of accounts payable with a service provider.Merger.

 

The fair value liability is revalued each balance sheet date utilizing probability-weighted Black-Scholes computations, with the decrease or increase in fair value being reported in the statement of operations as other income or expense, respectively.

 

Liquidity & Capital Resources

 

Working Capital Deficiency

 

 March 31, 2017  December 31, 2016  September 30, 2017 December 31, 2016 
Current assets $401,117  $316,480  $63,307  $316,480 
Current liabilities  (2,698,693)  (2,967,669)  (4,614,514)  (2,967,669)
Working capital deficiency $(2,297,576) $(2,651,189) $(4,551,207) $(2,651,189)

 

Current assets decreased by $253,173, which was attributable to a decrease in cash of $96,671 and a decrease in prepaid expenses of $156,502.

Current liabilities increased by $84,637,$1,646,845, which was primarily attributable to an increase of accounts payable of $364,247, an increase of $299,166 in cashamounts due related parties, and an increase of $111,094.

Current liabilities decreased by $268,976, which was primarily attributable$715,353 in convertible notes to a decrease of $675,674 in accrued expenses, which is primarily attributable to a reduction in approximately $947,000 in accrued legal fees through the issuance of 6,153,684 shares of the Company’s common stock during the three months ended March 31, 2017.related and unrelated parties.

26

 

Cash Flows

 

  Three Months Ended 
  March 31, 2017  March 31, 2016 
Net cash used in operating activities $(369,420) $(179,907)
Net cash used in investing activities  -   - 
Net cash provided by financing activities  480,514   - 
Increase (decrease) in cash and cash equivalents $111,094  $(179,907)

  Nine Months Ended 
  September 30, 2017  September 30, 2016 
       
Net cash used in operating activities $(923,202) $(296,143)
Net cash used in investing activities  (375,000)  - 
Net cash provided by financing activities  1,201,531   50,000 
Increase (decrease) in cash and cash equivalents $(96,671) $(246,143)

 

The increase in net cash used in operating activities forduring the threenine months ended March 31,September 30, 2017, compared to 2016, was mainly due to increased operating expenses as a resultsubsequent to the Merger, offset by non-cash stock compensation of the November 15, 2016 merger. Operating expenses for the three months ended March 31, 2017 includes the$272,000, amortization of intangibles of $328,000, an increase in accounts payable of $355,000, an increase in accrued expenses of both Marina$639,000 and IThena, while the operating expenses for the three months ended March 31, 2016 reflect only the operating expensesan increase in amounts due to related party of IThena.$353,000.

The Company used no cash of $300,000 in investing activities for payments towards the threeJuly 21, 2017 Prestalia acquisition and $75,000 towards the DyrctAxess acquisition during the nine months ended March 31, 2017 or 2016.September 30, 2017. This investment was made to transform the Company to be a commercial stage company from a development stage company.

 

The $480,514$1,151,531 increase in net cash provided by financing activities forduring the threenine months ended March 31,September 30, 2017, compared to 2016, is primarily attributable to proceeds of $250,000 from the sale of stock, and $230,514$380,888 from additional borrowings on the convertible note to related party duringnotes and convertible notes, $400,000 from the three months ended March 31, 2017.issuance of convertible notes, and $170,643 received from the conversion of warrants to common stock.

 

We will need to raise additional operating capital in calendar year 2017 in order to maintain our operations and to realize our business plan. Without additional sources of cash and/or the deferral, reduction, or elimination of significant planned expenditures, we may not have the cash resources to continue as a going concern thereafter.

 

Going Concern

 

The condensed consolidated financial statements contained in this report have been prepared assuming that the Companywill continue as a going concern. We have net lossesan accumulated deficit for the period from inception through March 31,September 30, 2017 in excess of approximately $3$5 million, as well as negative cash flows from operating activities. Management estimates that the cash balance asWe had obtained a line of March 31, 2017 of $216,441, along with the $500,000 Line Lettercredit from Autotelic Inc., will allow the Company of $500,000, of which we have utilized $92,590. As such, we currently have approximately $407,000 of available funds under our line of credit with Autotelic Inc. that is being used to continue itsmaintain operations. We believe that this available cash is sufficient to fund our operations and activities through the third or fourth quarter of 2017 without additional funding. Presently, the Company does not have sufficient cash resources to meet its plans in the twelve months following December 31, 2016.2017. These factors raise substantial doubt about our ability to continue as a going concern. Management is in the process of evaluating various financing alternatives for operations, as we will need to finance future research and development and operational activities and general and administrative expenses through fund raising in the public or private debt and equity markets.markets and strategic transactions.

 

The interim condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. Our continuation as a going concern is dependent on our ability to obtain additional financing as may be required and ultimately to attain profitability. If we raise additional funds through the issuance of equity or equity-linked securities, the percentage ownership of current shareholders could be reduced, and such securities might have rights, preferences or privileges senior to our common stock. Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, we may not be able to take advantage of prospective business endeavors or opportunities, which could significantly and materially restrict our future plans for developing our business and achieving commercial revenues. If we are unable to obtain the necessary capital when needed, we may have to cease operations.

 

During 2016 and 2017, we have funded our losses primarily through the sale of common and preferred stock and warrants, revenue provided from our license agreements, and loans provided by Dr. Trieu and Autotelic Inc. pursuant to the Line LetterLetters, the issuance of convertible notes and, to a lesser extent, equipment financing facilities and secured loans. During the first quarter ofnine months ended September 30, 2017, we raised $250,000 from the private placement of our equity securities, raised $400,000 from the issuance of convertible notes, received $170,643 from the conversion of warrants to common stock, and borrowed $230,514$380,888 under the Line Letter.Letter from Dr. Trieu. In addition, in April 2017, we entered into an additional credit agreement with Autotelic Inc., pursuant to which Autotelic Inc. offered to the Company an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses of the Company. We have utilized $92,590 and have approximately $407,000 available under the Line Letter with Autotelic Inc. We believe that the cash available to us under this Line Letter will be sufficient to fund our operations through December 31, 2017.

 

Future Financing

 

We will require additional funds to implement ourthe growth strategy for our business. As mentioned above, we have, in the past, raised additional capital to both supplement our commercialization, clinical developments that are not covered by any grant fundingdevelopment and to cover our operational expenses. We maywill need to raise the additional funds required through equity financing, debt financing, strategic alliances or other sources, which may result in further dilution in the equity ownership of our shares. There can be no assurance that additional financing will be available when needed or, if available, that it can be obtained on commercially reasonable terms. If we will not be able to obtain the additional financing on a timely basis as required, or generate significant material revenues from operations, we will not be able to meet our other obligations as they become due and will be forced to scale down or perhaps even cease our operations.

Off-Balance Sheet Arrangements

 

As of March 31,September 30, 2017, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.

 

Critical Accounting Policies and Estimates

 

Our significant accounting policies are more fully described in the notes to our financial statements included herein for the quarterperiod ended March 31,September 30, 2017 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016.

 

New and Recently Adopted Accounting Pronouncements

 

OurAny new and recently adopted accounting pronouncements are more fully described in Note 1 to our financial statements included herein for the quarterperiod ended March 31,September 30, 2017.

 

ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4 CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

 

a)       Disclosure Controls and Procedures. As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our senior management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Management identified material weaknesses in internal control over financial reporting as described under the heading “Management Report on Internal Control” contained in Item 9A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “2016 Form 10-K”), which have not been fully remediated, and therefore our principal executive officer and our principal financial officer concluded that, as of March 31,September 30, 2017, our disclosure controls and procedures were not effective.

 

(b)       Internal Control Over Financial Reporting.

Management has reported to the Board of Directors and the Audit Committee thereof material weaknesses described under the heading “Management Report on Internal Control” contained in Item 9A of the 2016 Form 10-K. The material weaknesses discussed therein have not been fully remediated. There have been no changes in our internal control over financial reporting or in other factors during the fiscal quarter ended March 31,September 30, 2017 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. To remediate the material weakness identified in the 2016our Form 10-K for the year ended December 31, 2016, we plan to hire additional experienced accounting and other personnel to assist with filings and financial record keeping, and to take additional steps to improve our financial reporting systems and enhance our existing policies, procedures and controls, as resources allow. In connection with such remediation efforts, in October 2017 we engaged Amit Shah to serve as our Chief Financial Officer.

 

Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

The Company has been named on a complaint filed in New York State as a defendant in the matter entitledVaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. While this complaint has been filed in the Supreme Court of the State of New York, the Company has not been legally served. The complaint alleges, in relevant part, that: (i) the sale by Symplmed Pharmaceuticals, Inc. of its assets related to its Prestalia product, and the sale by Symplmed Technologies, Inc. of its assets related to its DyrctAxess platform, should be set aside pursuant to New York law as they were consummated without fair consideration to the sellers (the “Symplmed Defendants”), and thereby had the effect of fraudulently depriving the creditors of the Symplmed Defendants, including Vaya Pharma, Inc., of funds that could have been used to pay their debts; and (ii) the Company is liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement the Company is only contractually responsible for liabilities that accrue after the parties entered into the agreement for Prestalia and any liabilities that existed prior to the agreement are contractually held by Symplmed. If and when the Company is legally served, it is the intention of the Company to dispute jurisdiction, the sufficiency of the pleading and the claims set forth in this complaint, and to defend this matter, vigorously. However, due to the inherent uncertainties of litigation, the ultimate outcome of this matter is uncertain. An unfavorable outcome could materially and adversely affect the business, financial condition and results of operations of the Company.

 

ITEM 1A. RISK FACTORS

 

An investment in our common stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of theour Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “Annual Report”), as filed with the Securities & Exchange CommissionSEC on March 31, 2017, in addition to other information contained in those documents and reports that we have filed with the SEC pursuant to the Securities Act of 1933, as amended, and inthe Securities Exchange Act of 1934, as amended, since the date of the filing of the Annual Report, including, without limitation, this quarterly reportQuarterly Report on Form 10-Q, in evaluating the Companyour company and its business before purchasing shares of our common stock. Our business, operating results and financial condition could be adversely affected due to any of those risks.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

On March 31,In September 2017, we entered into a Settlement Agreementan engagement letter with a debtor to, and shareholder of, our company,financial advisor pursuant to which, among other things, we agreed that indebtedness owed to our company byissue to such debtorfinancial advisor, in partial consideration of the principal amountservices to be rendered under the engagement letter, an aggregate of $45,000, plus accrued and unpaid interest thereon, would be settled through: (i) the payment by such debtor to our company of $14,059 in cash; (ii) the surrender by such debtor of 87,254500,058 shares of our common stock for cancellation; and (iii) the surrender by such debtor of warrants to purchase up to 60,000stock. The shares of our common stock at exercise prices ranging from $0.63 to $1.05 for cancellation.

In April 2017, we entered into a Compromise and Release Agreement to settle $36,047 due to a service provider for $15,957were issued in cash and the issuance to the service provider of 69,276 shares of our common stock.November 2017. The shares were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended.

During the fiscal quarter ended September 30, 2017 we issued 180,000 unregistered shares of common stock to the holders of our Series C Convertible Preferred Stock in connection with the conversion of 270 shares of our Series C Convertible Preferred Stock. These securities were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Rule 506(b) of Regulation D promulgated thereunder.

33

 

Item 6. Exhibits

 

Exhibit
Number No. Description
   
(10)3.1 Material ContractsCertificate of Amendment of the Amended and Restated Certificate of Incorporation of Marina Biotech, Inc. (filed as Exhibit 3.1 to our Current Report on Form 8-K filed on August 2, 2017, and incorporated herein by reference).
   
10.1#10.1 Employment LetterAmendment Agreement, dated February 2,July 3, 2017, betweenby and among Marina Biotech, Inc. and the Registrant and Joseph W. Ramellilenders signatory thereto (filed as Exhibit 10.1 to our Current Report on Form 8-K dated February 2,filed on July 5, 2017, and incorporated herein by reference).
   
10.2 StockAsset Purchase Agreement, dated as of February 6,July 21, 2017, by and between the Registrantamong Marina Biotech, Inc., Symplmed Pharmaceuticals LLC and Lipomedics Inc.Symplmed Technologies, LLC (filed as Exhibit 10.1 to our Current Report on Form 8-K dated February 6,filed on July 25, 2017, and incorporated herein by reference herein)reference).
   
10.3#10.3 Employment LetterIntellectual Property Purchase Agreement dated February 13,as of September 8, 2017 by and between the RegistrantMarina Biotech, Inc. and Larn Hwang, Ph.D.Novosom Verwaltungs GmbH (filed as Exhibit 10.1 to our Current Report on Form 8-K dated February 8,filed on September 14, 2017, andan incorporated herein by reference herein)reference).
   
10.4#10.4* Employment LetterLicense Agreement dated February 13,July 17, 2017 between the RegistrantMarina Biotech, Inc. and Mihir Munsif (filed as Exhibit 10.2 to our Current Report on Form 8-K dated February 8, 2017, and incorporated by reference herein).Oncotelic, Inc. (1)
   
10.5* LicenseAmendment Agreement, dated February 6,August 3, 2017, betweenby and among Marina Biotech, Inc. and the Registrant and Lipomedics, Inc. (1)
(31)Rule 13a-14(a)/15d-14(a) Certificationlenders signatory thereto
   
31.1* Certification of our Principal Executive Officer pursuant to Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended.
31.2*Certification of our Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
(32)Section 1350 Certification
   
32.1* Certification of our Principal Executive Officer andpursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*Certification of our Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (2)
(99)Additional Exhibits
   
99.1Press release announcing the grant of a patent for Bacteria Mediated Gene Silencing (EP 08768475.9, European Patent 2173875) claims by the European Patent Office relating to the Company’s tkRNAi technology being utilized in its CEQ508 program that is being developed to treat familial adenomatous polyposis (FAP) (filed as Exhibit 99.1 to our Current Report on Form 8-K dated January 3, 2017, and incorporated by reference herein).
99.2Audited Financial Statements of IThenaPhama, Inc. as of and for the years ended December 31, 2014 and 2015 and unaudited financial statements of IThenaPharma Inc as of and for the nine months ended September 30, 2015 and 2016 (filed as Exhibit 99.1 to our Current Report on Form 8-K/A dated November 15, 2016, as filed on January 26, 2017, and incorporated by reference herein).

99.3Unaudited Pro Forma Condensed Combined Financial Statements of Marina Biotech, Inc. and Subsidiaries (filed as Exhibit 99.1 to our Current Report on Form 8-K/A dated November 15, 2016, as filed on January 26, 2017, and incorporated by reference herein).
(101)**Interactive Data Files
101.INS101.INS* XBRL Instance Document
   
101.SCH101.SCH* XBRL Taxonomy Extension Schema Document
   
101.CAL101.CAL* XBRL Taxonomy Extension Calculation Linkbase Document
   
101.DEF101.DEF* XBRL Taxonomy Extension Definition Linkbase Document
   
101.LAB101.LAB* XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE101.PRE* XBRL Taxonomy Extension Presentation Linkbase Document

 

(1) Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and the omitted material has been filed separately with the SEC.

* Filed or furnished herewith.

*Filed herewith.
 
**Furnished herewith.
34 
#Indicates management contract or compensatory arrangement.
 

(1)

Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and the omitted material has been filed separately with the SEC.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

MARINA BIOTECH, INC.

  
Date: May 15,November 13, 2017/s/ Joseph W. Ramelli
 Joseph W. Ramelli
 Chief Executive Officer
 (Principal Executive Officer, PrincipalOfficer)
Date: November 13, 2017/s/ Amit Shah
Amit Shah
Chief Financial Officer
 (Principal Financial Officer and Principal Accounting Officer)

 

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