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

 

For the quarterly period ended:September 30, 2017March 31, 2018

 

or

 

[  ]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
(IRS Employer
incorporation ororganization) (IRS Employer
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. Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] 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 [  ] No [X].

 

AsAs of November 13, 2017,May 17, 2018, there were 10,521,27810,852,283 shares of the registrant’s common stock outstanding.

 

 

 

 

 

MARINA BIOTECH, INC.

FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017MARCH 31, 2018

 

TABLE OF CONTENTS

 

  Page
   
PART I -FINANCIAL INFORMATION3
   
ITEM 1Financial Statements (unaudited)3
   
 Condensed Consolidated Balance Sheets as of September 30, 2017March 31, 2018 and December 31, 201620173
   
 Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30,March 31, 2018 and 2017 and 20164
Condensed Consolidated Statement of Changes in Stockholders’ Equity as of September 30, 2017 and December 31, 20165
   
 Condensed Consolidated Statements of Cash Flows for the NineThree Months Ended September 30,March 31, 2018 and 2017 and 201665
   
 Notes to Condensed Consolidated Financial Statements76
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2423
   
ITEM 3.Quantitative and Qualitative Disclosures about Market Risk3432
   
ITEM 4.Controls and Procedures3432
   
PART II -OTHER INFORMATION 
   
ITEM 1.Legal Proceedings3533
   
ITEM 1A.Risk Factors3534
   
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds3534
   
ITEM 6.Exhibits3635
   
SIGNATURES3736

 

Items 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. AND SUBSIDIARIES

Condensed Consolidated Balance SheetsCONDENSED CONSOLIDATED BALANCE SHEETS

 

  September 30, 2017  December 31, 2016 
  (Unaudited)  (Audited) 
ASSETS        
         
Current assets        
Cash $8,676  $105,347 
Prepaid expenses and other assets  54,631   211,133 
Total current assets  63,307   316,480 
         
Intangible assets, net of amortization  2,679,235   2,311,877 
Goodwill  3,502,829   3,558,076 
   6,182,064   5,869,953 
         
Total assets $6,245,371  $6,186,433 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $1,027,508  $663,261 
Due to related party  382,332   83,166 
Accrued expenses  1,022,369   1,393,521 
Accrued fee payable  320,000   - 
Notes payable  441,023   435,998 
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  248,068   141,723 
Derivative liability  115,271   - 
Total current liabilities  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; 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 September 30, 2017 and December 31, 2016, respectively  -   - 
         
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  6,850,567   5,115,983 
Deferred compensation  (102,600)  - 
Accumulated deficit  (5,177,237)  (1,951,082)
         
Total stockholders’ equity  1,630,857   3,218,764 
         
Total liabilities and stockholders’ equity $6,245,371  $6,186,433 

  March 31, 2018  December 31, 2017 
    (unaudited)    
       
ASSETS        
         
Current assets        
Cash $47,768  $106,378 
Prepaid expenses and other assets  99,136   18,565 
Total current assets  146,904   124,943 
         
Intangible assets, net of amortization  2,432,713   2,555,974 
Goodwill  3,502,829   3,502,829 
   5,935,542   6,058,803 
         
Total assets $6,082,446  $6,183,746 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $1,462,259  $1,033,353 
Accrued expenses  1,187,185   1,139,369 
Due to related party  1,656,042   1,336,518 
Accrued fee payable  320,000   320,000 
Deferred revenue  200,000   - 
Notes payable  453,223   444,223 
Notes payable - related parties  1,597,784   1,462,040 
Total current liabilities  6,876,493   5,735,503 
         
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; 750 shares issued and outstanding as of March 31, 2018 and December 31, 2017, 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, 2018 and December 31, 2017, respectively  -   - 
        
Common stock, $0.006 par value; 180,000,000 shares authorized, 10,521,728 shares issued and outstanding as of March 31,2018 and December 31, 2017, respectively  63,127   63,127 
Additional paid-in capital  8,532,702   8,413,823 
Accumulated deficit  (9,389,876)  (8,028,707)
Total stockholders’ equity  (794,047)  448,243 
         
Total liabilities and stockholders’ equity $6,082,446  $6,183,746 

 

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

 

3

 

MARINA BIOTECH, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of OperationsCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

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

  For the Three Months Ended 
  March 31, 
  2018  2017 
       
Operating expenses        
         
Research and development $173,256  $73,431 
General and administrative  919,908   795,444 
Amortization  123,261   98,378 
Total operating expenses  1,216,425   967,253 
         
Loss from operations  (1,216,425)  (967,253)
         
Other expense        
         
Interest expense  (144,744)  (11,653)
Change in fair value liability of warrants  -   (103,072)
   (144,744)  (114,725)
         
Loss before provision for income taxes  (1,361,169)  (1,081,978)
         
Provision for income taxes  -   800 
         
Net loss $(1,361,169) $(1,082,778)
         
Net loss per share – basic and diluted $(0.13) $(0.12)
         
Weighted average shares outstanding  10,521,278   9,407,340 

 

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

4

MARINA BIOTECH, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Changes in Stockholders’ EquityCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

  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 
  For the Three Months Ended
March 31,
 
  2018  2017 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(1,361,169) $(1,082,778)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  118,879   62,240 
Common shares issued to third party for services  -   54,000 
Amortization of intangibles  123,261   98,378 
Non-cash interest expense  144,744   - 
Deferred revenue  200,000   - 
Change in fair value liabilities for price adjustable warrants  -   103,072 
Changes in operating assets and liabilities:        
Prepaid expenses and other assets  (80,571)  (4,947)
Accounts payable  428,906   10,742 
Accrued expenses  47,816   278,156 
Due to related party  319,524   117,167 
         
Net Cash Used in Operating Activities  (58,610)  (363,970)
         
Cash Flows from Financing Activities:        
         
Proceeds from sale of common stock to related party  -   250,000 
Proceeds from convertible notes due to related parties, net  -   225,064 
         
Net Cash Provided by Financing Activities  -   475,064 
         
Net increase (decrease) in cash  (58,610)  111,094 
         
Cash – Beginning of Period  106,378   105,347 
Cash - End of Period $47,768  $216,441 
         
Supplementary Cash Flow Information:        
Income taxes paid $-  $800 
Interest paid $-  $- 
         
Non-cash Investing and Financing Activities:        
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.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

5

 

  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     

 

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 SEPTEMBER 30, 2017MARCH 31, 2018

(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® (Prestalia), a single-pill fixed dose combination of perindopril argenine, an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine besylate, 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 isAs reported in our Annual Report on Form 10-K, in April 2018, we raised in excess of $10 million, net of fees and expenses, from a private placement of our newly created Series E Convertible Preferred Stock (See Recent Developments: Series E Convertible Preferred Share Private Placement Offering below). Further, in May 2018, we raised an additional $2 million, net of fees and expenses, from the private placement. The use of funds from the raise will primarily be on the commercialization of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and secondarilyother general corporate requirements. For the development of IT-102 and IT-103.IT-103, we will seek partners or raise additional funds to advance the development programs. 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.

 

6

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 IThenaPharmaStock Split

 

On November 15, 2016, Marina entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among 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”). For a more detailed discussion on the reverse merger, refer to Note 2 – Intangible Assets below as well as our 2016 Annual Report on Form 10K filed with the SEC.

IThena is a developer of personalized therapies for combined pain/hypertension through its proprietary Fixed Dose Combination (“FDC”) technology and point of care 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.

Reverse Stock Split

OnIn August 1, 2017, we filed a Certificate 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 OTCQB tier of the OTC 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 and Notes to the Consolidated Financial Statements give effect to the reverse split.

 

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 8 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, 2016,2017, included in our 20162017 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 ninethree months ended September 30, 2017March 31, 2018 are not necessarily indicative of the results for the year ending December 31, 20172018 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 September 30, 2017,March 31, 2018, we had a significant accumulated deficit of $5,177,237approximately $9 million and a negative working capital of $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.$7 million. Our operating activities consume the majority of our cash resources. We anticipate that we will continue to incur operating losses as we execute our commercialization plans for Prestalia, as well as strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from 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, combined with or without warrants, the sale of notes, revenue providedcash generated from the outlicensing or sale of our license agreementslicensed assets 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,April 2018, we funded operations primarily throughraised over $10 million net proceeds from a private placement of shares of our Series E Convertible Preferred Stock, and warrants to purchase shares of our common stock. Further, in May 2018, we raised an additional $2 million net proceeds from the issuancesame private placement. For our assessment as of convertible debtMarch 31, 2018, we have considered the amount raised and license-related revenues.

There is substantial doubt about ourwe believe that the $12 million will provide us the ability to continue as a going concern for one year from the issuance date of this Form 10-Q, which10-Q. We may affect our abilitycontinue to attempt 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.

7

 

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, legal contingencies 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 ourThere were no liabilities measured at fair value on a recurring basis as of September 30, 2017 andMarch 31, 2018 or December 31, 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 

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

  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 nine months ended September 30, 2017 was determined using the probability adjusted Black-Scholes option pricing model using exercise prices of $2.80 to $7.50, stock price of $2.70, volatility of 174% to 225%, contractual lives of 0.1 to 4.1 years, and risk-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%.2017.

 

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

8

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 September 30, 2017March 31, 2018 or December 31, 2016.2017.

Revenue Recognition

The Company has adopted the scope and in accordance with ASC 606,Revenue from Contracts with Customers(ASC 606) commencing the period under report.

The Company analyzes its contracts to assess that they are within the scope and in accordance with ASC 606,Revenue from Contracts with Customers(ASC 606). In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, whether for goods and services or licensing, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

In terms of licensing agreements entered into by the Company, they typically include payment of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services; and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services.

Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s consolidated balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company’s consolidated balance sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer.

At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the performance obligation does not provide the customer with a material right.

The Company considers the terms of the contract and its customary business practices to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.

If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices. The relative selling price for each deliverable is estimated using objective evidence if it is available. If objective evidence is not available, the Company uses its best estimate of the selling price for the deliverable.

Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the good or service promised to the customer.

After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception.

Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the stand-alone selling prices of identified performance obligations, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations.

9

Recently Issued Accounting Pronouncements

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). Under the provisions of ASU 2014-09, entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange for goods and services provided. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017. The Company adopted the provisions of this standard effective January 1, 2018.

 

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, 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:

 

 Nine months ended
September 30,
  Three months ended March 31, 
 2017 2016  2018  2017 
          
Stock options outstanding  233,400   -   764,707   233,400 
Warrants  2,492,945   13,917   2,548,481   2,703,000 
Convertible Notes Payable  315,746   - 
Restricted common stock  70,000     
Shares to be issued upon conversion of notes payable  323,404   171,612 
        
Total  3,112,091   13,917   3,636,592   3,108,012 

Reclassification of Prior Year Presentation

Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations or cash flows.

10

 

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 SymplmedPrestalia & Dyrct Axess

 

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$620,000 (consisting of $0.4 million$300,000 in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $0.32 million)$320,000), 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.

The purchase price of $620,000 has been allocated based on a preliminary estimate of the fair value of the assets acquired and is included in intangible assets as of December 31, 2017 and is subject to change.

 

Further, we entered into an offer letter to hirehired our current Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective onin 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 vestvesting on the six (6) month anniversary of the date of grant. These shares were fully vested on December 31, 2017.

 

In furtherance of the acquisition and commercialization of Prestalia, onin 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 includedcare for $75,000 in intangible assets as of September 30, 2017, and is subject to change.cash.

 

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
  Estimated
Fair Value
  Estimated
Useful Life
(Years)
  Annual
Amortization
Expense
 
Intangible asset from Merger $2,361,066   6  $393,511  $2,361,066   6.0  $393,511 
Intangible asset - Prestalia  620,000   6   103,333   620,000   6.6   94,177 
Intangible asset – DyrctAxess  75,000   6   12,500   75,000   14.0   5,357 
Total $3,056,066      $509,344  $3,056,066      $493,045 

 

The net intangible asset was $2,679,235,$2,432,713, net of accumulated amortization of $376,831,$623,353, as of September 30, 2017.March 31, 2018. Amortization expense was $327,642$123,261 and $0$98,378 for the ninethree months ended September 30,March 31, 2018 and 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 and Interim CEO, Autotelic Inc., effective November 15, 2016. Autotelic Inc. currently owns less than 10%5% 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.

11

 

During the period commencing November 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 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 will 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”), 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. For the ninethree months ended September 30,March 31, 2018 and 2017, and 2016, Autotelic Inc. billed a total of $492,406$256,997 and $238,673,$213,103, including personnel costs of $386,954$133,633 and $99,425,$158,140, respectively. An unpaid balance of $382,332$916,270 and $730,629 is recorded asincluded in due to related party in the accompanying balance sheet as of September 30, 2017.March 31, 2018 and December 31, 2017, respectively. The Company agreed to issue warrants at a future date for the remaining balance due of $388,745,$739,772, which is included in accrued expensesdue to related parties as of 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,March 31, 2018. Upon the completion of certain funding events, IThena had the right to convert the outstanding principal amount of these notes into shares of the IThena’s common 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 a private placement of our Series E Convertible Preferred Stock (Preferred Shares), Autotelic, Inc. agreed to convert the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, our Executive Chairman, for an unsecured line of credit in an amount notentire unpaid balance due to exceed $540,000, to be used for current operating expenses. Dr. Trieu has advanced the full $540,000 under the Line Letterit as of September 30, 2017 ($250,000 as of DecemberMarch 31, 2016). Accrued interest on the Line Letter was $19,029 and $0 as of September 30, 2017 and December 31, 2016, 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 time2018 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 creditSeries E Convertible Preferred Stock and warrants 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 525,535 shares of Marina common stock as a resultfull and complete satisfaction of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board. Autotelic Inc. 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. 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. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissoryunpaid balance. Also see Note issued to Autotelic Inc., and are 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.

9 – Subsequent Events below.

 

Note 4 – Notes Payable

Following is a breakdown of notes payable as of March 31, 2018 and December 31, 2017:

  March 31, 2018  December 31, 2017 
       
Notes payable $97,523  $97,523 
Convertible notes payable  355,700   346,700 
Total notes payable $453,223  $444,223 
         
Notes payable – related parties  94,782  $93,662 
Convertible notes payable – related parties (net of debt discount of $0 and $113,170 as of March 31, 2018 and December 31, 2017, respectively)  1,503,002   1,368,378 
Total notes payable – related parties $1,597,784   $1,462,040 

Note Payable – Service Provider

In December 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, which was not paid. The balance due on the note was $97,523 as of March 31, 2018 and December 31, 2017, respectively.

12

 

Note Purchase Agreement and Amendment

 

In June 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 was to accrueaccrued on the unpaid principal balance of the Notes at the rate of 12% per annum beginning on September 20, 2016. The Notes were 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.2017.

 

In July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to those Notes and the warrants to purchase shares of our common stock that are currently held by the Purchasers and that were originally issued pursuant to a certain Note and Warrant Purchase Agreement dated as of February 10, 2012 by and among Marina, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto (as amended from time to time), to, among other things, extend the maturity date of the Notes to December 31, 2017, issuance of consideration securities at a cost of $375,000 (“Consideration Securities”) 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, 2020. Refer to our Form 10-Q for the six months ended June 30, 2017 for a more detailed discussion and additional terms for these Notes.

 

As of September 30,March 31, 2018 and December 31, 2017, the accrued interest expense on the Notes amounted to $37,500,$55,700 and $46,700, respectively, with a total balance of principal and interest of $337,500.

Note Payable – Service Provider$355,700 and $346,700, respectively.

 

In December 2016, we enteredThe unpaid principal balance of the Notes, together with accrued and unpaid interest thereon, as well as the $375,000 of Consideration Securities converted into an Agreementshares of Series E Convertible Preferred Stock and Promissory Note withwarrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018. As a law firm for past services performed totaling $121,523. The note calls for monthly paymentsresult 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 ifthe conversion of the Notes, all obligations of the Company pays $100,000 by December 31, 2017. The balance due onto the note was $103,523 as of September 30, 2017.Purchasers thereunder have been satisfied and the Notes are no longer outstanding. Also see Note 9 – Subsequent Events below .

 

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,March 31, 2018 and December 31, 2017, the accrued interest expense on the Notes amounted to $6,324,$16,297 and $11,365, with a total balance of principal and interest of $406,324.$416,297 and $411,365, respectively, and is included in convertible notes payable – related parties on the accompanying balance sheet.

The unpaid principal balance of the Notes, together with accrued and unpaid interest thereon, converted into shares of Series E Convertible Preferred Stock and warrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018. As a result of the conversion of the Notes, all obligations of the Company to the holders of the Notes thereunder have been satisfied and the Notes are no longer outstanding. Also see Note 9 – Subsequent Events below.

13

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, IThena had the right to convert the outstanding principal amount of these notes into shares of IThena’s common stock. The notes were assumed by Autotelic Inc. on November 15, 2016 as part of its acquisition of the technology asset (IT-101).

InNovember 2017, the Company issued a convertible promissory note with a related party for $500,000, with annual interest at 8%, maturing on March 31, 2018, and convertible at the price equal to any financing transaction involving the sale by the Company of its equity securities yielding aggregate gross proceeds to the Company of not less than $5 million. Total principal and interest was $514,137 and $504,274 as of March 31, 2018 and December 31, 2017, respectively, and is included in convertible notes to related parties on the accompanying balance sheet. The note included warrants to purchase 66,667 shares of the Company’s common stock, with a 5-year term and an exercise price of $0.75  . The note included a debt discount of $162,210 consisting of loan costs of $50,000 and the fair value of the warrants of $112,210. Total amortization of this debt discount was $113,171 for the quarter ended March 31, 2018, with a remaining unamortized value of $0. The net balance of the note of $514,137 is included in convertible notes to related parties on the accompanying balance sheet at March 31, 2018.

The unpaid principal balance of the related party note, together with accrued and unpaid interest thereon, automatically converted into shares of Series E Convertible Preferred Stock and Warrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018. As a result of the conversion of the related party note, all obligations of the Company to the holder under such note have been satisfied and the note is no longer outstanding. Also see Note 9 – Subsequent Events below.

Convertible Notes Payable, Dr. Trieu

In connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, our Executive Chairman and Interim CEO, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses. Dr. Trieu has advanced the full $540,000 under the Line Letter as of December 31, 2017. Accrued interest on the Line Letter was $32,568 and $25,836 as of March 31, 2018 and December 31, 2017, 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 $1.77 per share.

The unpaid principal balance of the line of credit, together with accrued and unpaid interest thereon, converted into shares of Series E Convertible Preferred Stock and Warrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018, as discussed in the Note 9. As a result of the conversion of the line of credit, all obligations of the Company to Dr. Trieu thereunder have been satisfied and the line of credit is no longer outstanding.

Line Letter with Autotelic Inc.

InApril 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 525,535 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board. Autotelic Inc. was to consider requests for advances under the Line Letter until September 1, 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. 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 Inc., and are due and payable upon demand by Autotelic, Inc. Autotelic Inc. advanced funds after September 1, 2017 but is no longer considering additional requests for advances as of December 31, 2017.

The balance under the line was $94,782, including accrued interest of $3,966 as of March 31, 2018, and is included in notes to related parties on the accompanying balance sheet. Since this line was not extended, no further funds are available under this line of credit.

The unpaid principal balance of the line of credit, together with accrued and unpaid interest thereon, converted into shares of Series E Convertible Preferred Stock and warrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018, as discussed in the Note 9. As a result of the conversion of the line of credit, all obligations of the Company to Autotelic Inc. thereunder have been satisfied and the line of credit is no longer outstanding.

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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”). In April 2018, Marina designated 3,500 shares of Series E Convertible Preferred Stock,

 

Series C Preferred

 

Each share of Series C Preferred has a stated value of $5,000 per share, has a $5,100 liquidation preference per share, has voting rights of 666.67 votes 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. OnIn 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.stock.

 

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 344,000 shares of Marina’s common stock at an initial exercise price of $4.00 per share before August 2021, for an aggregate purchase price of $1.1 million. Each share of Series D Preferred has a stated value of $5,000 per share, has a liquidation preference of $300 per share, has voting rights of 1,250 votes per share and is convertible into shares of common stock at a conversion price of $4.00 per share. The Series D Preferred is initially convertible into an aggregate of 275,000 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. In November 2015, an investor converted 50 shares of Series D Preferred into 62,500 shares of common stock. In February 2016, an investor converted 110 shares of Series D Preferred into 137,500 shares of common stock.

 

Series E Convertible Preferred Shares

In connection with a private placement, in April 2018 we created a new Series E Convertible Preferred Stock (Preferred Shares). Also see Note 9 – Subsequent Events below.

Each share of Series E Convertible Preferred Stock has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.50 per share. In connection with the private placement, we issued 3,500 Preferred Shares for cash and settlement of certain debt and liabilities.

Common Stock

 

Our common stock currently trades on the OTCQB tier of the OTC Markets.Markets under the symbol “MRNA”.

 

Stock Issuances

 

In February 2017, we entered into two privately negotiated transactions pursuant to which weWe issued an aggregate of 615,368no shares of our common stock for an effective price per share of $2.90 to settle aggregate liabilities of approximately $948,000, which had been reflected in accrued expenses as of December 31, 2016.

In February 2017, we issued 30,000 shares of our common stock with a fair value of $1.80 per share to a consultant providing investment advisory services.

In February 2017, we issued 10,000 restricted shares of our common stock with a fair value of $1.40 per share to our CEO for services.

In February 2017, we entered into a Stock Purchase Agreement with LipoMedics, a related party, pursuant to which we issued to LipoMedics an aggregate of 86,207 shares of our common stock for a total purchase price of $250,000.

In March 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 6,000 warrants, and the surrender of 8,725 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 toduring the service provider in May 2017.three months ended March 31, 2018.

 

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.

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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 September 30, 2017,March 31, 2018, there were 2,492,9452,548,481 warrants outstanding, with a weighted average exercise price of $4.40$3.95 per share, and annual expirations as follows:

 

Expiring in 2017-
Expiring in 2018  11,383252 
Expiring in 2019  600,000 
Expiring in 2020  1,189,079 
Expiring in 2021  343,750 
Expiring in 202266,667
Expiring thereafter  348,733 
   2,492,9452,548,481 

 

On May 21,The above includes price adjustable warrants totaling 1,895,013 which are described more fully in our 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.Annual Report on Form 10-K.

 

A total of 149,11111,131 warrants expired in May 2017.during the three months ended March 31, 2018.

 

Note 6 — Stock Incentive Plans

 

Stock Options

 

Stock option activity was as follows:

 

  Options Outstanding 
  Shares  Weighted
Average
Exercise Price
 
Outstanding, December 31, 2016  168,811  $36.80 
Options granted  64,600   1.70 
Options expired  (11)  5,264.00 
Outstanding, September 30, 2017  233,400   26.85 
Exercisable, September 30, 2017  193,100  $32.10 
  Options Outstanding 
  Shares  Weighted
Average
Exercise Price
 
Outstanding, December 31, 2017  745,707  $8.84 
Options granted  19,000   1.56 
Options expired  -   - 
Outstanding, March 31, 2018  764,707   8.66 
Exercisable, March 31, 2018  209,096  $26.48 

 

The following table summarizes additional information on Marina’s stock options outstanding at September 30, 2017:March 31, 2018:

 

 Options Outstanding  Options Exercisable 

Range of

Exercise
Prices

Number
Outstanding
  Weighted-
Average
Remaining
Contractual
Life (Years)
  Weighted
Average
Exercise
Price
  Number
Exercisable
  Weighted
Average
Exercise Price
 
$0.10 14,000   4.30  $1.00   14,000  $1.00 
$0.17 - .018 64,600   4.13   1.72   24,300   1.70 
$0.26 - 0.82 48,400   2.73   4.62   48,400   4.62 
$1.07 - $2.20 102,150   5.74   10.73   102,150   10.73 
$47.60 - $87.60 2,100   .69   676.00   2,100   676.00 
$127.60 - $207.60 2,150   .69   1,582.98   2,150   1,582.98 
Totals 233,400   4.53  $26.85   193,100  $32.10 

   Options Outstanding  Options Exercisable 
Range of
Exercise
Prices
  Number Outstanding  Weighted- Average Remaining Contractual Life (Years)  Weighted Average Exercise Price  Number Exercisable  Weighted Average Exercise Price 
$1.00   14,000   3.63  $1.00   14,000  $1.00 
$1.50 – $1.80   553,007   8.84   1.78   117,396   1.74 
$2.60 – $8.20   168,400   3.87   3.15   48,400   4.62 
$10.70 – $22.00   25,050   1.48   10.81   25,050   10.81 
$476.00 - $876.00   2,100   .19   676.00   2,100   676.00 
$1276.00 - $2076.00   2,150   .19   1,582.98   2,150   1,582.98 
 Totals   764,707   7.36  $8.66   209,096  $26.48 

 

Weighted-Average Exercisable Remaining Contractual Life (Years) 4.534.44

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In January 2017,2018, the Company granted a total of 48,60019,000 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-year anniversary of the grant date. The options have an exercise price of $1.70$1.56 and a five-year term.

In February 2017, the Company granted a totalAs of 16,000 stock options to key employees for services. The options vest on the one-year anniversary of the grant date, have an exercise price of $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 September 30, 2017,March 31, 2018, we had $36,573$830,621 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $59,568$118,879 for the ninethree months ended September 30, 2017.March 31, 2018.

 

At September 30, 2017,As ofMarch 31, 2018, the intrinsic value of options outstanding or exercisable was $201,100$5,600 as there were 101,80014,000 options outstanding with an exercise price less than $2.80,$1.40, 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 with Novosom Verwaltungs GmbH (“Novosom”), pursuant to which Marina acquired intellectual property for Novosom’s SMARTICLES-based liposomal delivery system. In February 2016, Marina issued Novosom 20,548 shares of common stock valued at 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 $250,000 and could receive up to $40 million in success-based milestones. In April 2016, Marina issued Novosom 47,468 shares of common stock valued at approximately $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 $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 $50,000 per the terms of this license agreement. In November 2016, we issued 11,905 shares with a value of $15,000 to Novosom as the equity component owed under Marina’s July 2016 license agreement.

In May 2018, we issued to Novosom 51,988 shares of our common stock as additional consideration pursuant to the Asset Purchase Agreement, dated as of July 27, 2010, between our company and Novosom. Such shares were due to Novosom as a result of the receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc. in February 2017.

 

Arrangements with LipoMedics

 

In February 2017, we entered into a License Agreement (the “License Agreement”) with 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 and Marina 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 86,207 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 $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., our Executive Chairman and Interim CEO, is the Chairman of the Board and Chief Operating Officer of LipoMedics.

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In consideration Lipomedics agreed to the following fee schedule: 1) Evaluations License Fee. Simultaneous with the execution and delivery of the 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 $0.25 million, with the purchase price for each share of Marina common stock being $2.90. 2) Commercial License Fee. Unless the 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 $10 million upon reaching Commercial Sales in the Territory in any given twelve month period equal to or greater than $500 million for a given Licensed Product and of $20 million upon reaching Commercial Sales in any given twelve month period equal to or greater than $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 Oncotelic has not completed the termspurchase of the License Agreement,stock and we could receive uphave not been able to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if Oncotelic determinesreach to pursue further development and commercialization of products undera definitive agreement, as such we have terminated 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.agreement.

 

SaleLicense of DiLA2 Assets

 

In July 2017, weOn March 16, 2018, Marina entered into a binding term sheetLicensing Agreement, whereby Marina granted exclusive rights to the company’s DiLA2delivery system in exchange for an upfront payment of $200,000 and further potential future consideration dependent upon event and sales-based milestones. Under the terms of the agreement, Marina has agreed to assign ownership of the intellectual property associated 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 subjectsystem to the negotiation, execution and delivery of a definitive asset purchasepurchaser. The Company has yet to complete certain performance obligations under the agreement and Purchaser’s determination that its due diligenceaccordingly has been completed and has been found satisfactory, in Purchaser’s sole discretion.

Indeferred the term sheet, we agreed that we will negotiate exclusively with Purchaser with respect torecognition of revenue from 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, negotiationsasset until such obligations 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.fulfilled.   

 

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).

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Note 8 – Commitments and Contingencies

 

Amendment 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’sour activities, the Company iswe are subject to claims and/or threatened legal actions, which arise out of the normal course of business. Other than the disclosure below, as of the date of this filing, the Company iswe are not aware of any pending lawsuits against the Company, itsus, our officers or our directors.

 

The Company hasWe had 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 hashad been filed in the Supreme Court of the State of New York, the Company haswe had not been legally served. The complaint alleges,alleged, 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 iswe were liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement the Company iswe are 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. IfIn April 2018, we entered into a Stipulation of Settlement requiring us to issue to Vaya Pharma shares of our common stock with a fair value of $250,000, which shares were issued in the second fiscal quarter of 2018. We accrued $250,000, as of March 31, 2018 and whenDecember 31, 2017, respectively, and such amount was included in accrued expenses on 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.accompanying consolidated balance sheets.

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Note 9 - Subsequent Events

 

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.

 

Series E Convertible Preferred Share Private Placement Offering

In September 2017,April and May 2018, we entered into an engagement letterSubscription Agreements with certain accredited investors and conducted a financial advisorclosing pursuant to which amongwe sold 2,812shares of our Series E convertible preferred stock (the “Preferred Stock”), at a purchase price of $5,000 per share of Preferred Stock. Each share of Preferred Stock is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Preferred Stock, the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Preferred Stock has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in April 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.

We received proceeds of approximately $12 million from the sale of the Securities, after deducting placement agent fees and estimated expenses payable by us of approximately $2 million associated with such closing. We intend to use the proceeds of the offering for funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures, the repayment of certain liabilities and other things,general corporate purposes. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 2,958,460 shares of our common stock.

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Stipulation of Settlement

As discussed in Note 8, in April 2018, we entered into a Stipulation of Settlement requiring us to issue Vaya Pharma shares of our common stock with a fair value of $250,000, which shares were issued in the second fiscal quarter of 2018. We accrued $250,000, as of March 31, 2018 and December 31, 2017, respectively, and such amount is included in accrued expenses on the accompanying consolidated balance sheets.

Resignation of Officer and Directors

In May 2018, the Board accepted the resignation of Joseph W. Ramelli, our Chief Executive Officer, whereby Mr. Ramelli resigned as an officer of our company, and as a director and/or officer of any and all subsidiaries of our company, effective immediately, to pursue other opportunities. In connection with his resignation, Mr. Ramelli released us from all claims arising prior to the date of his resignation and affirmed his obligations to be bound by the restrictive covenants contained in the employment agreement between Mr. Ramelli and our company dated February 2, 2017, and we: (i) agreed to make severance payments to Mr. Ramelli in the amount of $60,000 to be paid over a six (6) month period; and (ii) granted to Mr. Ramelli fully-vested options, exercisable for a period of five years from the grant date, to purchase up to 100,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. In May 2018, the Board appointed Vuong Trieu, our Executive Chairman, to serve as our Interim Chief Executive Officer, to replace Mr. Ramelli, effective immediately. In his capacity as Interim Chief Executive Officer, Dr. Trieu shall receive a salary in the amount of $20,000 per month.

In May 2018, each of Philip C. Ranker and Philippe P. Calais, Ph.D. resigned as members of the Board, and all committees thereof, effective immediately. In connection with their resignations: (i) each of Mr. Ranker and Dr. Calais released us from all claims arising prior to the date of his resignation; (ii) we granted to Mr. Ranker fully-vested options to purchase up to 200,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock; and (iii) we granted to Dr. Calais fully-vested options to purchase up to 80,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. The foregoing options are exercisable for a period of five years from the grant date.

Issuance of Preferred Stock and Warrants to Directors

In April 2018, and in connection with the closing of our private placement on that date, we entered into Compromise and Settlement Agreements with four of the current members of our Board of Directors and one former member of our Board of Directors pursuant to which we agreed to issue to such financial advisor, in partial consideration of the services to be rendered under the engagement letter,directors an aggregate of 500,05858.25 shares of our common stock. The shares were issued in November 2017.

In October 2017, we appointed our Chief Financial OfficerPreferred Stock and our Chief Legal Officer. In connection with these appointments, we granted to each such officer optionsWarrants to purchase up to 60,000436,875 shares of common stock to satisfy accrued and unpaid fees owed to such directors for service as members of the Board of Directors during the period ending on December 31, 2017 in the aggregate amount of approximately $291,250. The Securities that were issued to the directors, which were issued upon the closing of our private placement described above, have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities to June 2016 Noteholders

In April 2018, and in connection with the closing of our private placement on that date, we issued to the holders (such holders, the “June 2016 Noteholders”) of those certain promissory notes in the original principal amount of $300,000 that we issued pursuant to that certain Note Purchase Agreement dated June 20, 2016 by and among our company and the June 2016 Noteholders (the “2016 Notes”) an aggregate of 71.46 shares of Preferred Stock and Warrants to purchase up to 535,950 shares of common stock as a result of the conversion of the 2016 Notes. As a result of the conversion of the 2016 Notes and the issuance of the Securities to the June 2016 Noteholders, the entire unpaid principal balance of the 2016 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding.

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In addition, in April 2018, and in connection with the closing of our private placement on that date, we issued to the June 2016 Noteholders an aggregate of 75 shares of Preferred Stock and Warrants to purchase up to 562,500 shares of common stock in full and complete satisfaction of our obligations to issue $375,000 worth of “Consideration Securities” to the 2016 Noteholders pursuant to that certain amendment agreement dated July 3, 2017 by and among our company and the June 2016 Noteholders.

Issuance of Securities to June 2017 Noteholders

In April 2018, and in connection with the closing of our private placement on that date, we issued to the holders of those certain promissory notes in the original principal amount of $400,000 (the “2017 Notes”) that we issued to select accredited investors (the “June 2017 Noteholders”) pursuant to Note Purchase Agreements that we entered into with the June 2017 Noteholders during June 2017 an aggregate of 83.44 shares of Preferred Stock and Warrants to purchase up to 625,800 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to the June 2017 Noteholders under the 2017 Notes. As a result of the conversion of the 2016 Notes and the issuance of the Securities to the June 2016 Noteholders, the entire unpaid principal balance of the 2016 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding. The Securities that were issued to the June 2017 Noteholders have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities to Blech Trust

In April 2018, and in connection with the closing of our private placement on that date, we issued to a trust affiliated with Isaac Blech, a member of our Board of Directors, an aggregate of 103.18 shares of Preferred Stock and Warrants to purchase up to 777,750 shares of common stock as a result of the conversion of that certain secured convertible promissory note in the original principal amount of $500,000 that we issued to such investor on November 22, 2017 (the “Blech Note”). As a result of the conversion of the Blech Note and the issuance of the Securities to the holder thereof, the entire unpaid principal balance of the Blech Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and the Blech Note is no longer outstanding. The Securities that were issued to the holder of the Blech Note have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities to Satisfy Lines of Credit

In April 2018, and in connection with the closing of our private placement on that date, we issued to Vuong Trieu, Ph.D., our Executive Chairman, 114.63 shares of Preferred Stock and Warrants to purchase up to 859,725 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to Dr. Trieu under that certain line of credit in the amount of up to $540,000 that was provided by Dr. Trieu to us, all of which had been drawn down as of the date of the closing of our private placement. The line of credit was extended pursuant to a Line Letter dated November 15, 2016 by and between us and Dr. Trieu. The Securities that were issued to Dr. Trieu have the same terms and conditions as the Securities that were issued to investors in the offering.

In April 2018, and in connection with the closing of our private placement on that date, we issued to Autotelic Inc. 19 shares of Preferred Stock and Warrants to purchase up to 142,500 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to Autotelic Inc. under that certain line of credit in the amount of up to $500,000 that was provided by Autotelic Inc. to us, of which $90,816 had been drawn down as of the date of the closing described above. The line of credit was extended pursuant to a Line Letter dated April 4, 2017 by and between us and Autotelic Inc. Vuong Trieu, our Executive Chairman and Interim CEO, serves as Chairman of the Board of Autotelic Inc. The Securities that were issued to Autotelic Inc. have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities for Payables

In April 2018, and in connection with the closing of our private placement on that date, we entered into a Compromise and Settlement Agreement with Autotelic Inc. pursuant to which we agreed to issue to Autotelic Inc. an aggregate of 162.59 shares of Preferred Stock and Warrants to purchase up to 2,564,465 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount of approximately $812,967, and other liabilities, owed to Autotelic Inc. as of March 31, 2018 pursuant to that certain Master Services Agreement dated as of November 15, 2016 by and between our company and Autotelic Inc. Vuong Trieu, our Executive Chairman and Interim CEO, serves as Chairman of the Board of Autotelic Inc. The Securities that were issued to Autotelic Inc., which were issued upon the closing described above, have the same terms and conditions as the Securities that were issued to investors in the offering.

Stock Issuance to Novosom

In May 2018, we issued to Novosom Verwaltungs GmbH (“Novosom”) 51,988 shares of our common stock underas additional consideration pursuant to the Asset Purchase Agreement, dated as of July 27, 2010, between our 2014 Long-Term Incentive Plan, with all of such options vestingcompany and becoming exercisable on the one-year anniversaryNovosom. Such shares were due to Novosom as a result of the grant date.receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc. in February 2017.

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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.April 17, 2018. 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 are inherently subject to risks and uncertainties, many of which we cannot predict with accuracy and some of which we might not even anticipate. Although we believe that the expectations reflected in such forward-looking statements are based upon reasonable assumptions at the time made, we can give no assurance that such expectations will be achieved. Future events and actual results, financial and otherwise, may differ materially from the results discussed in a quarterly reportthe forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements after the date of this Annual Report on Form 10-Q may include statements about:10-K or to conform them to actual results, new information, future events or otherwise, except as otherwise required by securities and other applicable laws.

The following factors, among others, could cause our or our industry’s future results to differ materially from historical results or those anticipated:

 

our continued 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 and at terms acceptable to us;otherwise;
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, 2016,2017, as filed with the SEC on March 31, 2017,April 17, 2018, 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.

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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. We 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, and its wholly-owned subsidiaries, , MDRNA Research, Inc., Cequent Pharmaceuticals, Inc., Atossa Healthcare, Inc., and Atossa HealthCare, Inc.; and IThenaPharmaIthenaPharma, 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.”

Corporate Overview

 

We are 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. Our 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. 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 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® (Prestalia), a single-pill fixed dose combination of perindopril argenine, an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine besylate, 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 isAs reported in our Annual Report on Form 10-K, in April, 2018, we raised in excess of $10 million, net of fees and expenses, from a private placement of our newly created Series E Convertible Preferred Stock (See Recent Developments: Series E Convertible Preferred Share Private Placement Offering below). Further, in May 2018, we raised an additional $2 million, net of fees and expenses, from the private placement. The use of funds from the raise will primarily be on the commercialization of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and secondarilyother general corporate requirements. For the development of IT-102 and IT-103.IT-103, we will seek partners or raise additional funds to advance the development programs. 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.

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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

 

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, 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”). IThena is deemedFor a more detailed discussion on the reverse merger, refer 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 reflectedNote 2 – Intangible Assets in our quarterly and annual reports for periods ending afterNotes to the effective time of the Merger, or November 15, 2016. Accordingly, beginning withFinancial Statements as well as our 2017 Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as10K filed with the SEC on March 31, 2017, we have reported the results of IThena and Marina and their respective subsidiaries on a consolidated basis. As a result of the Merger, while we have presented the results for the three and nine 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 include IT-102 and IT-103, FDCs 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.SEC.

 

Acquisition of Prestalia

 

Subsequent to the Merger we executed on our strategy to become a commercial stage company with the acquisition of Prestalia from Symplmed. Specifically, on June 6, 2017 we entered into an Asset Purchase Agreement with 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 (“CCB”), and is indicated as a first line therapy for hypertension control.

 

We believe that the acquisition 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 our focus will be dedicated to re-acquiring prior Prestalia patients, with subsequent efforts dedicated to building a strong sales team to fully market the product. This includes our efforts to re-establish our relationships with our contract manufacturers to support marketing Prestalia.

 

We 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 promotion and commercialization of our two other hypertension pipeline products – namely IT-102 and IT-103, as well as any other similar products that we internally develop or acquire.

 

Line Letters with Related Parties

 

In connection with the Merger, Marina entered into a line of creditLine Letter dated November 15, 2016 with Dr. Trieu, our Executive Chairman and Interim CEO, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses (“Line Letter”). As of September 30, 2017,expenses. Dr. Trieu has advanced an aggregate of $540,00 under the Line Letter. Advances madefull $540,000 under the Line Letter bearas of December 31, 2017. Accrued interest on the Line Letter was $32,568 and $25,836 as of March 31, 2018 and December 31, 2017, 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 rateCompany’s common stock at a price of five percent (5%)$1.77 per annum, are evidenced byshare.

The unpaid principal balance of the line of credit, together with accrued and unpaid interest thereon, converted into shares of Series E Convertible Preferred Stock and warrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018. As a demand promissory note issuedresult of the conversion of the line of credit, all of our obligations to Dr. Trieu thereunder have been satisfied and are due and payable upon demand by Dr. Trieu.the line of credit is no longer outstanding.

 

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On

InApril 4, 2017, we 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 525,535 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board. Autotelic Inc. was to consider requests for advances under the Line Letter until September 1, 2017. The Company and Autotelic Inc. areshall have the right at any time for any reason in discussionsits sole and absolute discretion to extend thisterminate the line letter through December 31, 2017.of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice. 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 Inc., and are due and payable upon demand by Autotelic. We currently have approximately $407,000Autotelic, Inc. Autotelic Inc. advanced funds after September 1, 2017 but is no longer considering additional requests for advances as of December 31, 2017.

The balance under the line was $94,782, including accrued interest of $3,966 as of March 31, 2018, and is included in notes to related parties on the accompanying balance sheet. Since this line was not extended, no further funds are available funds under this line of credit. We believe that this available cash is sufficient to fund our operations through December 31, 2017.

The unpaid principal balance of the line of credit, together with accrued and unpaid interest thereon, converted into shares of Series E Convertible Preferred Stock and warrants to purchase shares of common stock upon the closing of our private placement of Series E Convertible Preferred Stock and warrants in April 2018. As a result of the conversion of the line of credit, all of our obligations to Autotelic Inc. thereunder have been satisfied and the line of credit is no longer outstanding.

Recent Developments During the Three Months Ended September 30, 2017March 31, 2018

 

Amendment of Notes and WarrantsAgreement with Autotelic BIO

 

On July 3, 2017,January 11, 2018, we entered into an amendmenta binding agreement with Autotelic BIO (“ATB”) pursuant to which, among other things, and subject to the satisfaction of certain conditions on or prior to January 15, 2019, we shall grant to ATB a perpetual exclusive right of development and marketing of our IT-103 product candidate, which is a fixed dose combination of celecoxib and olmesartan medoxomil (the “Amendment Agreement”“Product”), at the currently approved dose/approved indications only for celecoxib (100 mg, 200mg and 400mg) for combined hypertension and arthritis only, with such right extending throughout the entire world (excluding the United States and Canada, and the territories of such countries) (the “Territory”). The grant of the license would be memorialized in a definitive license agreement to be entered into between the parties. The conditions to the grant of the license include, without limitation, that: (i) ATB shall obtain funding in a certain specified amount (the “Fundraising”); or (ii) ATB shall obtain a co-development and licensing deal with other third-party pharmaceutical companies with respect to the Product; or (iii) ATB shall obtain a government-sponsored research and development project in the Republic of Korea.

The agreement provides that, following the date on which the license is granted: (A) if ATB should sub-license the Product, we and ATB would share all proceeds of such sub-license equally; and (B) if ATB markets the Product on its own, ATB would provide us with a royalty equal to a percentage of net profits in the mid-single digits. The agreement also provides that ATB will make a payment to us in the amount of $100,000 upon the successful completion of the Fundraising, and a payment to us in the amount of $300,000 following the date on which we have provided certain specified technology and assistance regarding the manufacturing and production of the Product. We will be entitled to the clinical trial data and any enhancements and inventions developed by ATB during this process.

Autotelic LLC, an entity that owns approximately 22% of the issued and outstanding shares of our common stock and of which Dr. Trieu, our Executive Chairman and Interim CEO, serves as Chief Executive Officer, owns approximately 19% of the issued and outstanding shares of the common stock of ATB.

Sale of DiLA2 Assets

On March 16, 2018, we entered into a Licensing Agreement, whereby we granted exclusive rights to our DiLA2 delivery system in exchange for an upfront payment of $200,000 and further potential future consideration dependent upon event and sales-based milestones. Under the terms of the agreement, we agreed to assign ownership of the intellectual property associated with the DiLA2delivery system. The Company has yet to complete certain performance obligations under the agreement and accordingly has deferred the recognition of revenue from the sale of the asset until such obligations are fulfilled.   

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Series E Convertible Preferred Stock Private Placement

In April 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 2,334 shares of our Series E convertible preferred stock (the “Preferred Stock”), at a purchase price of $5,000 per share of Preferred Stock. Further in May 2018, we sold 478 shares of our Preferred Stock. Each share of Preferred Stock is initially convertible into shares of our common stock at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with the Preferred Stock, the “Securities”) to purchase 0.75 shares of our common stock for each share of common stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Preferred Stock has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in April 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.

We received total proceeds of approximately $12 million from the sale of the Securities, after deducting placement agent fees and estimated expenses payable by us associated with such closing. We intend to use the proceeds of the offering for funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures, the repayment of certain liabilities and other general corporate purposes. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 2,958,460 shares of our common stock.

Stipulation of Settlement

As discussed in Note 8, in April 2018, we entered into a Stipulation of Settlement requiring us to issue Vaya Pharma shares of our common stock with a fair value of $250,000, which shares were issued during the second fiscal quarter of 2018. We accrued $250,000, as of March 31, 2018 and December 31, 2017, respectively, and such amount is included in accrued expenses on the accompanying consolidated balance sheets.

Resignation of Officer and Directors

In May 2018, the Board accepted the resignation of Joseph W. Ramelli, our Chief Executive Officer, whereby Mr. Ramelli resigned as an officer of our company, and as a director and/or officer of any and all subsidiaries of our company, effective immediately, to pursue other opportunities. In connection with his resignation, Mr. Ramelli released us from all claims arising prior to the date of his resignation and affirmed his obligations to be bound by the restrictive covenants contained in the employment agreement between Mr. Ramelli and our company dated February 2, 2017, and we: (i) agreed to make severance payments to Mr. Ramelli in the amount of $60,000 to be paid over a six (6) month period; and (ii) granted to Mr. Ramelli fully-vested options, exercisable for a period of five years from the grant date, to purchase up to 100,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. In May 2018, the Board appointed Vuong Trieu, our Executive Chairman, to serve as our Interim Chief Executive Officer, to replace Mr. Ramelli, effective immediately. In his capacity as Interim Chief Executive Officer, Dr. Trieu shall receive a salary in the amount of $20,000 per month.

In May 2018, each of Philip C. Ranker and Philippe P. Calais, Ph.D. resigned as members of the Board, and all committees thereof, effective immediately. In connection with their resignations: (i) each of Mr. Ranker and Dr. Calais released us from all claims arising prior to the date of his resignation; (ii) we granted to Mr. Ranker fully-vested options to purchase up to 200,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock; and (iii) we granted to Dr. Calais fully-vested options to purchase up to 80,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. The foregoing options are exercisable for a period of five years from the grant date.

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Issuance of Preferred Stock and Warrants to Directors

In April 2018, and in connection with the closing of our private placement described above, we entered into Compromise and Settlement Agreements with four of the current members of our Board of Directors and one former member of our Board of Directors pursuant to which we agreed to issue to such directors an aggregate of 58.25 shares of Preferred Stock and Warrants to purchase up to 436,875 shares of common stock to satisfy accrued and unpaid fees owed to such directors for service as members of the Board of Directors during the period ending on December 31, 2017 in the aggregate amount of approximately $291,250. The Securities that were issued to the directors, which were issued upon the closing described above, have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities to June 2016 Noteholders

In April 2018, and in connection with the closing of our private placement described above, we issued to the holders (such holders, the “June 2016 Noteholders”) of those certain promissory notes in the aggregateoriginal principal amount of $300,000 (each a “Note” and collectively the “Notes”) that we issued to two accredited investors (the “Purchasers”) pursuant to that certain Note Purchase Agreement dated June 20, 2016 by and among usour company and the PurchasersJune 2016 Noteholders (the “Purchase Agreement”“2016 Notes”), an aggregate of 71.46 shares of Preferred Stock and those certain warrantsWarrants to purchase up to an aggregate of 951,263535,950 shares of our common stock that were originally issued pursuant to that certain Note and Warrant Purchase Agreement dated as of February 10, 2012 by and among the Company, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and the purchasers identified on the signature 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 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.

Arrangements with Oncotelic Inc.

On July 17, 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 $250,000 ($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 $500,000, 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.

Dr. Trieu, our Executive Chairman, is the 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 Purchaser 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 consist of: (i) an initial payment of $300,000 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.

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 DiLA 2 outside of gene editing.

Acquisition of DyrctAxess Platform

On July 21, 2017, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with 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 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. 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 August 1, 2017, we filed a Certificate 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 OTCQB tier of the 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 the reverse split. No fractional shares were issuedconversion of the 2016 Notes. As a result of the conversion of the 2016 Notes and the issuance of the Securities to the June 2016 Noteholders, the entire unpaid principal balance of the 2016 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding.

In addition, in April 2018, and in connection with the reverse split; any fractionclosing of a shareour private placement described above, we issued to the June 2016 Noteholders an aggregate of 75 shares of Preferred Stock and Warrants to purchase up to 562,500 shares of common stock that would otherwise have resulted from the reverse split was rounded upin full and complete satisfaction of our obligations to issue $375,000 worth of “Consideration Securities” to the nearest whole share of common stock.2016 Noteholders pursuant to that certain amendment agreement dated July 3, 2017 by and among our company and the June 2016 Noteholders.

 

AmendmentIssuance of Securities to Agreement with Windlas Healthcare Private LimitedJune 2017 Noteholders

 

On August 17,In April 2018, and in connection with the closing of our private placement described above, we issued to the holders of those certain promissory notes in the original principal amount of $400,000 (the “2017 Notes”) that we issued to select accredited investors (the “June 2017 Noteholders”) pursuant to Note Purchase Agreements that we entered into with the June 2017 Noteholders during June 2017 an amendment (the “Amendment”)aggregate of 83.44 shares of Preferred Stock and Warrants to purchase up to 625,800 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to the June 2017 Noteholders under the 2017 Notes. As a result of the conversion of the 2016 Notes and the issuance of the Securities to the June 2016 Noteholders, the entire unpaid principal balance of the 2016 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding. The Securities that were issued to the June 2017 Noteholders have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities to Blech Trust

In April 2018, and in connection with the closing of our private placement described above, we issued to a trust affiliated with Isaac Blech, a member of our Board of Directors, an aggregate of 103.18 shares of Preferred Stock and Warrants to purchase up to 777,750 shares of common stock as a result of the conversion of that certain Pharmaceutical Developmentsecured convertible promissory note in the original principal amount of $500,000 that we issued to such investor on November 22, 2017 (the “Blech Note”). As a result of the conversion of the Blech Note and the issuance of the Securities to the holder thereof, the entire unpaid principal balance of the Blech Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and the Blech Note is no longer outstanding. The Securities that were issued to the holder of the Blech Note have the same terms and conditions as the Securities that were issued to investors in the offering.

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Issuance of Securities to Satisfy Lines of Credit

In April 2018, and in connection with the closing of our private placement described above, we issued to Vuong Trieu, Ph.D., our Executive Chairman and Interim CEO, 114.63 shares of Preferred Stock and Warrants to purchase up to 859,725 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to Dr. Trieu under that certain line of credit in the amount of up to $540,000 that was provided to us by Dr. Trieu, all of which had been drawn down as of the date of the closing described above. The line of credit was extended pursuant to a Line Letter dated November 15, 2016 by and between our company and Dr. Trieu. The Securities that were issued to Dr. Trieu have the same terms and conditions as the Securities that were issued to investors in the offering.

In April 2018, and in connection with the closing of our private placement described above, we issued to Autotelic Inc. 19 shares of Preferred Stock and Warrants to purchase up to 142,500 shares of common stock as full and complete satisfaction of the unpaid principal balance (and accrued but unpaid interest thereon) owed by us to Autotelic Inc. under that certain line of credit in the amount of up to $500,000 that was provided to us by Autotelic Inc., of which $90,816 had been drawn down as of the date of the closing described above. The line of credit was extended pursuant to a Line Letter dated April 4, 2017 by and between Autotelic Inc. and us. Vuong Trieu, our Executive Chairman and Interim CEO, serves as Chairman of the Board of Autotelic Inc. The Securities that were issued to Autotelic Inc. have the same terms and conditions as the Securities that were issued to investors in the offering.

Issuance of Securities for Payables

In April 2018, and in connection with the closing of our private placement described above, we entered into a Compromise and Settlement Agreement with Autotelic Inc. pursuant to which we agreed to issue to Autotelic Inc. an aggregate of 162.59 shares of Preferred Stock and Warrants to purchase up to 2,564,465 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount of approximately $812,967, and other liabilities, owed to Autotelic Inc. as of March 31, 2018 pursuant to that certain Master Services Agreement dated as of March 30, 2017November 15, 2016 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,and Autotelic Inc. Vuong Trieu, our Executive Chairman and Interim CEO, serves 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%)Chairman of the total amount reflected on invoices sent from timeBoard of Autotelic Inc. The Securities that were issued to time by WindlasAutotelic Inc., which were issued upon the closing described above, have the same terms and conditions as the Securities that were issued to us,investors in the offering.

Stock Issuance to Novosom

In May 2018, we issued to Novosom Verwaltungs GmbH (“Novosom”) 51,988 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 Windlasas additional consideration 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 “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”). We previously acquired such Smarticles IP from Novosom pursuant to that certain Asset Purchase Agreement, dated as of July 27, 2010, between usour company and Novosom. Such shares were due to Novosom (the “Original Purchase Agreement”). Following the dateas a result of the Original Purchasereceipt by our company of a license fee under the License Agreement that 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 $1.00Lipomedics Inc. in cash, and thereafter we shall no longer be responsible for the 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 Original Purchase Agreement to any portion of such payments.February 2017.

 

Appointment of Executive Officers

On October 2, 2017, we entered into an Offer Letter with Amit Shah pursuant to which Mr. Shah shall serve 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 to the performance 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 become effective unless and until the closing of a single capital raising transaction involving the issuance by us of our equity (or equity-linked) securities yielding aggregate gross proceeds to us 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 one-year anniversary of the grant date.

Results of Operations

 

Comparison of the Three Months Ended September 30, 2017March 31, 2018 to the Three Months Ended September 30,March 31, 2017

 

Our loss before income taxes for the three months ended September 30, 2017March 31, 2018 is summarized as follows in comparison to the three months ended 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.March 31, 2017.

 

 Three Months Ended  Three Months Ended 
 September 30, 2017 September 30, 2016  March 31, 2018  March 31, 2017 
Revenues $-  $- 
     
Research and development  232,896   50,683  $173,256  $73,431 
General and administrative expenses  680,063   47,065   919,908   795,444 
Amortization  123,038   -   123,261   98,378 
Other income (expense), net  63,813   (378)
Other expense  144,744   114,725 
Loss before provision for income taxes $(972,184) $(98,126) $(1,361,169) $(1,081,978)

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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 relatesMarch 31, 2018 or 2017, respectively. As the Company has yet to amortizationcomplete certain performance obligations under the agreement, we have deferred the recognition of intangible assets acquired inrevenue of $200,000 from 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.

Comparisonsale 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:

  Nine Months Ended 
  September 30, 2017  September 30, 2016 
Revenues $-  $- 
Research and development  746,221   107,910 
General and administrative expenses  1,878,301   232,469 
Amortization  327,642   - 
Other income (expense), net  (273,191)  (378)
Loss before provision for income taxes $(3,225,355) $(340,757)

Revenues

We had no in revenues in the nine months ended September 30, 2017 or 2016.DiLA2 assets until such obligations are fulfilled.   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 ninethree months ended September 30, 2017March 31, 2018 are summarized as follows in comparison to our expenses for the nine months ended 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.March 31, 2017.

 

Research and Development

 

Research and development (“R&D”) expense increased by $638,311,$99,825, as compared to the ninethree months ended September 30, 2016,March 31, 2017, 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$85,243, and on a non-cash basis, through the issuance of warrants valued at $245,255.$85,493 for the three months ended March 31, 2018, partially offset by lower other R&D expenses. 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 $1,645,832$124,464 for the ninethree months ended September 30, 2107,March 31, 2108, as compared to the ninethree months ended September 30, 2016,March 31, 2017, primarily due to personnel costs and costsa charge of $375,000 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 issuancesettlement of warrants valued at $141,699. Other G&A expenses consistedour 2016 notes, an increase in stock option expense of legal$74,639, an increase in insurance costs of approximately $540,000,$18,380, and an increase in payroll expense of $81,667. These increases were partially offset by a decrease in accounting and auditing fees of approximately $194,000, approximately $169,000 for board member$67,374 and a decrease in legal fees and approximately $97,000 for insurance costs. No similar expenses were recorded during the nine months ended September 30, 2016.of $304,092.

 

Amortization Expense

 

Amortization expenses relates to amortization of intangible assets acquired in the MergerNovember 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)Expense

 

 Nine Months Ended  Three Months Ended 
 September 30,2017 September 30, 2016  March 31, 2018  March 31, 2017 
Interest expense $(51,575) $(378) $(144,744) $(11,653)
Change in fair value liability of warrants  (106,345)  -   -   (103,072)
Change in fair value of derivative liability  (115,271)  - 
Total other expense, net $(273,191) $(378) $(144,744) $(114,725)

 

Total net other expense for the ninethree months ended September 30, 2017March 31, 2018 increased $272,813$30,019 compared to the ninethree months ended September 30, 2016.March 31, 2017. The increase is primarily attributable to an increase in the estimated fair value of price adjustable warrants and derivative liability and interest expense onfrom new notes payable acquiredassumed since the three months ended March 31, 2017. There was no gain or loss on the change in the Merger.

The fair value liability is revalued each balance sheet dateof warrants during the three months ended March 31, 2018 due to the adoption of Accounting Standards Update 2017-11 in November 2017 relating to the issuance of financial statements that include down round provisions 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.modified retrospective approach.

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Liquidity & Capital Resources

 

Working Capital Deficiency

 

 September 30, 2017 December 31, 2016  March 31, 2018  December 31,2017 
Current assets $63,307  $316,480  $146,904  $124,943 
Current liabilities  (4,614,514)  (2,967,669)  (6,876,493)  (5,735,503)
Working capital deficiency $(4,551,207) $(2,651,189) $(6,729,589) $(5,610,560)

 

Current assets decreasedincreased by $253,173,$21,961, which was attributable to an increase in prepaid expenses of $80,571 offset by a decrease in cash of $96,671 and a decrease in prepaid expenses of $156,502.$58,610.

 

Current liabilities increased by $1,646,845,$1.140,990, which was primarily attributable to an increase of accounts payable of $364,247,$428,906, an increase of $299,166$319,524 in amounts due related parties, deferred recognition of revenue of $200,000 from the sale of the DiLA2 asset and an increase of $715,353$135,744 in convertible notes to related and unrelated parties.

 

Cash Flows

 

 Nine Months Ended  Three Months Ended 
 September 30, 2017 September 30, 2016  March 31, 2018  March 31, 2017 
          
Net cash used in operating activities $(923,202) $(296,143) $(58,610) $(363,970)
Net cash used in investing activities  (375,000)  -   -   - 
Net cash provided by financing activities  1,201,531   50,000   -   475,064 
Increase (decrease) in cash and cash equivalents $(96,671) $(246,143)
Increase (decrease) in cash $(58,610) $111,094 

 

The increasedecrease in net cash used in operating activities during the ninethree months ended September 30, 2017,March 31, 2018, compared to 2016,2017, was mainly due to increased operating expenses subsequent to the Merger,our net loss of $1,361,169, offset by non-cash stock compensation of $272,000, amortization of intangibles of $328,000, an increase in accounts payable of $355,000,$428,906, an increase in accrued expenses of $639,000$47,816 and an increase in amounts due to related party of $353,000.

The Company used cash of $300,000 in investing activities for payments towards the July 21, 2017 Prestalia acquisition and $75,000 towards the DyrctAxess acquisition during the nine months ended September 30, 2017. This investment was made to transform the Company to be a commercial stage company from a development stage company.$319,524.  

 

The $1,151,531 increase$475,064 in net cash provided by financing activities during the ninethree months ended September 30,March 31, 2017, compared to 2016, is primarily attributable to proceeds of $250,000 from the sale of stock, $380,888and $230,514 from additional borrowings on the convertible note to related party notes and convertible notes, $400,000 from the issuance of convertible notes, and $170,643 received from the conversion of warrants to common stock.party.

 

We

Going Concern and Management’s Liquidity Plans

The accompanying condensed consolidated financial statements have been prepared on the basis that 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 containedwhich contemplates realization of assets and the satisfaction of liabilities in this report have been prepared assumingthe normal course of business. At March 31, 2018, we had a significant accumulated deficit of approximately $9 million and a negative working capital of approximately $7 million. Our operating activities consume the majority of our cash resources. We anticipate that the Companywe will continue to incur operating losses as a going concern. We have an accumulated deficitwe execute our commercialization plans for the period from inception through September 30, 2017 in excess of $5 million,Prestalia, as well as strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from operating activities.operations, at least into the near future. 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 with Autotelic Inc. that is being used to maintain operations. We believe that this available cash is sufficient to fund our operations through December 31, 2017. These factors raise substantial doubt about our abilitypreviously funded, and plan 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 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 fundedfunding, our losses primarily through the sale of common and preferred stock, andcombined with or without warrants, revenue providedthe sale of notes, cash generated from the outlicensing or sale of our license agreements, loans provided by Dr. Trieu and Autotelic Inc. pursuant to the Line Letters, the issuance of convertible noteslicensed assets and, to a lesser extent, equipment financing facilities and secured loans. During the nine months ended September 30, 2017,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 April, 2018, we raised $250,000over $10 million net proceeds from thea private placement of shares of our equity securities,Series E Convertible Preferred Stock, and warrants to purchase shares of our common stock. Further, in May 2018, we raised $400,000an additional $2 million net proceeds from the same private placement. For our assessment as of March 31, 2018, we have considered the amount raised and we believe that the $12 million will provide us the ability to continue as a going concern for one year from the issuance date of convertible notes, received $170,643 fromthis Form 10-Q. We may continue to attempt to obtain future financing or engage in strategic transactions and may require us to curtail our operations. We cannot predict, with certainty, the conversionoutcome of warrantsour actions to common stock, and borrowed $380,888 undergenerate liquidity, including the Line Letter from Dr. Trieu. In addition, in April 2017, we entered into anavailability of additional credit agreement with Autotelic Inc., pursuant to which Autotelic Inc. offered toequity or debt financing, or whether such actions would generate 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.expected liquidity as currently planned

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Future Financing

 

We will require additional funds to implement the growth strategy for our business. As mentioned above, we have, in the past, raised additional capital to both supplement our commercialization, clinical development and operational expenses. We will need to raise 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 September 30, 2017,March 31, 2018, 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 period ended September 30, 2017March 31, 2018 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016.2017.

 

New and Recently Adopted Accounting Pronouncements

 

Any new and recently adopted accounting pronouncements are more fully described in Note 1 to our financial statements included herein for the period ended September 30, 2017.March 31, 2018.

 

ITEM 33. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 44. CONTROLS AND PROCEDURES

 

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, 20162017 (the “2016“2017 Form 10-K”), which have not been fully remediated, and therefore our principal executive officer and our principal financial officer concluded that, as of September 30, 2017,March 31, 2018, our disclosure controls and procedures were not effective.

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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 20162017 Form 10-K. The material weaknesses discussed therein have not been fully remediated. In connection with such remediation efforts, in October 2017 we engaged Amit Shah to serve as our Chief Financial Officer . There have been no changes in our internal control over financial reporting or in other factors during the fiscal quarter ended September 30, 2017March 31, 2018 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. To remediate the material weakness identified in our Form 10-K for the year ended December 31, 2016,2017, 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

We had been named onin a complaint filed in the Supreme Court of the State of 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.Inc While this. Although the complaint hashad been filed, in the Supreme Court of the State of New York, the Company haswe had not been legally served. The complaint alleges,alleged, 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 iswe were liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement the Company iswe were 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. IfIn April 2018, we entered into a Stipulation of Settlement requiring us to issue to Vaya Pharma shares of our common stock with a fair value of $250,000, which shares were issued in the second fiscal quarter of 2018. We accrued $250,000, as of March 31, 2018 and whenDecember 31, 2017, respectively, and such amount was included in accrued expenses on the Companyaccompanying consolidated balance sheets.

Our Prestalia product is legally served, itcurrently involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This challenge, which is currently pending in the intentionUnited States District Court for the District of Delaware (No. 1:17-cv-00276), is captionedApotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratoires Servier. The challengers (Apotex Inc. and Apotex Corp. (“Apotex”)) have filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Prestalia and included a Paragraph (IV) certification. In the litigation, Apotex seeks a declaratory judgment that no valid claims of the Companytwo patents Symplmed listed in the FDA Orange Book as having claims covering Prestalia, U.S. Patent No. 6,696,481 and 7,846,961, will be infringed by the Apotex proposed generic version of Prestalia and that the claims of those patents are invalid. The challenge is designed to dispute jurisdiction,provide Apotex with an opportunity to enter the sufficiencymarket with a generic version of Prestalia, ahead of the pleadingexpiration of the patents with claims covering that product. Apotex entered into negotiations with Symplmed Pharmaceuticals, LLC (which entity sold its assets relating to Prestalia to us in June 2017, including its License and Commercialization Agreement with Les Laboratories Servier) and Les Laboratories Servier (which entity owns or controls intellectual property rights relating to pharmaceutical products containing as an active pharmaceutical ingredient perindopril in combination with other active pharmaceutical ingredients, which rights have been licensed to Symplmed Pharmaceuticals) to resolve the claims set forthchallenge in this complaint,the second quarter of 2017, and such parties, along with us, have come to defend this matter, vigorously. However, duea general agreement on terms that will result in a delay to the inherent uncertaintieschallengers’ ability to enter the market with a generic version of litigation,Prestalia, while still providing the ultimate outcome of this matter is uncertain. An unfavorable outcome could materially and adversely affectchallenger with the business, financial condition and results of operationsright to enter the market prior to the expiration of the Company.patent covering such product. The term sheet memorializing such terms is pending execution in a final settlement agreement. In the meantime, the District Court has entered an order extending the time for the defendants to respond to Apotex’s Complaint .  Resolution of the Apotex litigation continues with alignment from all parties, including Servier, Apotex, Symplmed and Marina. Necessary extensions have been agreed upon and final resolution is anticipated this year.

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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 our Annual Report on Form 10-K for the fiscal year ended December 31, 20162017 (the “Annual Report”), as filed with the SEC on March 31, 2017,April 17, 2018, in addition to other information contained in those documents and reports that we have filed with the SECSecurities and Exchange commission pursuant to the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, since the date of the filing of the Annual Report, including, without limitation, this Quarterly Report on Form 10-Q, in evaluating our 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

 

In September 2017,April 2018, we entered into an engagement letter with a financial advisor pursuant to which, among other things, we agreedStipulation of Settlement in the matter entitledVaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc., requiring us to issue to such financial advisor, in partial consideration of the services to be rendered under the engagement letter, an aggregate of 500,058Vaya Pharma shares of our common stock. Thestock with a fair value of $250,000, which shares were issued in November 2017. TheMay 2018. We issued he shares in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended.

In May 2018, we issued to Novosom Verwaltungs GmbH (“Novosom”) 51,988 shares of our common stock as additional consideration pursuant to the Asset Purchase Agreement, dated as of July 27, 2010, between our company and Novosom. Such shares were due to Novosom as a result of the receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc. in February 2017. We issued the shares 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.

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Item 6. Exhibits

 

Exhibit
No.
 Description
3.1 Certificate of AmendmentDesignation of Preferences, Rights and Limitations of the Amended and Restated Certificate of Incorporation of Marina Biotech, Inc.Series E Convertible Preferred Stock (filed as Exhibit 3.1 to our Current Report on Form 8-K filed on August 2, 2017,dated April 16, 2018, and incorporated herein by reference).
   
10.14.1 Amendment Agreement,Common Stock Purchase Warrant dated July 3, 2017, by and among Marina Biotech, Inc. and the lenders signatory theretoas of April 16, 2018 (filed as Exhibit 10.14.1 to our Current Report on Form 8-K filed on July 5, 2017,dated April 19, 2018, and incorporated herein by reference).reference.)
   
10.2Asset Purchase Agreement, dated July 21, 2017, by and among Marina Biotech, Inc., Symplmed Pharmaceuticals LLC and Symplmed Technologies, LLC (filed as Exhibit 10.1 to our Current Report on Form 8-K filed on July 25, 2017, and incorporated herein by reference).
10.3Intellectual Property Purchase Agreement dated as of September 8, 2017 by and between Marina Biotech, Inc. and Novosom Verwaltungs GmbH (filed as Exhibit 10.1 to our Current Report on Form 8-K filed on September 14, 2017, an incorporated herein by reference).
10.4*License Agreement dated July 17, 2017 between Marina Biotech, Inc. and Oncotelic, Inc. (1)
10.5*Amendment Agreement, dated August 3, 2017, by and among Marina Biotech, Inc. and the lenders signatory thereto
31.1*31.1 Certification of our Principal Executive Officer pursuant to RulesRule 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
   
31.2*31.2 Certification of our Principal Financial Officer pursuant to RulesRule 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
   
32.1*32.1 Certification of our Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (2)
   
32.2*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)

101INSXBRL Instance Document (1)
   
101.INS*101SCH XBRL InstanceTaxonomy Extension Schema Document (1)
   
101.SCH*XBRL Taxonomy Extension Schema Document
101.CAL*101CAL XBRL Taxonomy Extension Calculation Linkbase Document (1)
   
101.DEF*101DEF XBRL Taxonomy Extension Definition Linkbase Document (1)
   
101.LAB*101LAB XBRL Taxonomy Extension Label Linkbase Document (1)
   
101.PRE*101PRE XBRL Taxonomy Extension Presentation Linkbase Document (1)

 

(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.

(1)Filed herewith.
(2)Furnished herewith.

 

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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: November 13, 2017May 18, 2018

By:/s/ Joseph W. RamelliVuong Trieu, Ph.D.
 Joseph W. RamelliVuong Trieu, Ph.D.
 Interim Chief Executive Officer
 (Principal Executive Officer)
  
Date: November 13, 2017May 18, 2018/s/ Amit Shah
 Amit Shah
 Chief Financial Officer
 (Principal Financial Officer and Principal Accounting Officer)

 

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