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

 

For the quarterly period ended:June 30, 2018March 31, 2019

 

or

 

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

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

 

For the transition period from _____________ to _____________.

 

Commission File Number:000-13789

 

MARINA BIOTECH,ADHERA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 11-2658569

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

incorporation or organization)

Identification No.)

   

17870 Castleton Street,4721 Emperor Boulevard, Suite 250350

City of Industry, CaliforniaDurham, NC

 

 

9174827703

(Address of principal executive offices) (Zip Code)

 

(626) 964-5788(919) 578-5901

(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].

 

As of AugustMay 10, 2019, there were 11,241,68410,869,530 shares of the registrant’s common stock outstanding.

 

 

 

   

 

MARINA BIOTECH,ADHERA THERAPEUTICS, INC.

FORM 10-Q

FOR THE THREE AND SIX MONTHSQUARTERLY PERIOD ENDED JUNE 30, 2018MARCH 31, 2019

 

TABLE OF CONTENTS

 

 Page
  
PART I - FINANCIAL INFORMATION 
   
ITEM 1Financial Statements (unaudited)3
   
 Condensed Consolidated Balance Sheets as of June 30, 2018March 31, 2019 and December 31, 201720183
   
 Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30,March 31, 2019 and 2018 and 20174
   
 Condensed Consolidated StatementStatements of Stockholders’ Equity for the SixThree Months ended June 30,Ended March 31, 2019 and 20185
   
 Condensed Consolidated StatementsStatement of Cash Flows for the SixThree Months Ended June 30,March 31, 2019 and 2018 and 20176
   
 Notes to Condensed Consolidated Financial Statements7
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2422
   
ITEM 3.Quantitative and Qualitative Disclosures about Market Risk3527
   
ITEM 4.Controls and Procedures3627
   
PART II - OTHER INFORMATION
   
ITEM 1.Legal Proceedings3628
   
ITEM 1A.Risk Factors3729
   
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds3729
   
ITEM 6.Exhibits3830
   
SIGNATURES3931

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,ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

  March 31, 2019  December 31, 2018 
  (Unaudited)    
ASSETS      
         
Current assets        
Cash $1,828,476  $3,918,290 
Accounts receivable, net of allowance  39,388   48,289 
Inventory  258,007   241,458 
Prepaid expenses and other assets  491,177   469,142 
Total current assets  2,617,048   4,677,179 
         
Operating lease right of use asset  208,830   - 
Furniture and fixtures, net of depreciation  68,852   71,774 
Intangible assets, net of amortization  374,317   391,892 
Total non-current assets  651,999   463,666 
         
Total assets $3,269,047  $5,140,845 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $322,633  $270,138 
Due to related party  52,658   27,977 
Accrued expenses  850,180   851,870 
Current portion of operating lease liability  88,940   - 
Accrued dividends  1,445,825   1,064,141 
Total current liabilities  2,760,236   2,214,126 
         
Other lease liability, net of current portion  126,540   - 
Total liabilities  2,886,776   2,214,126 
         
Commitments and contingencies (Note 9)        
         
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; 100 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  -   - 
         
Series D convertible preferred stock, $0.01 par value; $300 liquidation
preference; 220 shares authorized; 40 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  -   - 
         
Series E convertible preferred stock, $0.01 par value; $5,000 liquidation
preference; 3,500 shares authorized; 3,488 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  35   35 
         
Series F convertible preferred stock, $0.01 par value; $5,000 liquidation
preference; 2,200 shares authorized; 381 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  3   3 
         
Common stock, $0.006 par value; 180,000,000 shares authorized;
10,761,684 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
  64,570   64,570 
Additional paid-in capital  29,105,306   28,709,916 
Accumulated deficit  (28,787,643)  (25,847,805)
         
Total stockholders’ equity  382,271   2,926,719 
         
Total liabilities and stockholders’ equity $3,269,047  $5,140,845 

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

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

  June 30, 2018  December 31, 2017 
  (Unaudited)    
ASSETS        
         
Current assets        
Cash $8,354,122  $106,378 
Inventory  79,767   - 
Prepaid expenses and other assets  211,693   18,565 
Total current assets  8,645,582   124,943 
         
Furniture and fixtures, net of depreciation  10,066   - 
Intangible assets, net of amortization  2,309,451   2,555,974 
Goodwill  3,502,829   3,502,829 
   5,822,346   6,058,803 
         
Total assets $14,467,928  $6,183,746 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $1,134,557  $1,033,353 
Due to related party, including warrant liability  91,614   1,336,518 
Accrued expenses  911,295   1,139,369 
Accrued fee payable  -   320,000 
Deferred revenue  200,000   - 
Notes payable  -   444,223 
Notes payable - related parties  -   1,462,040 
Total current liabilities  2,337,466   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; 100 and 750 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively  -   - 
         
Series D convertible preferred stock, $0.01 par value; $300 liquidation
preference; 220 shares authorized; 40 and 60 shares issued and outstanding
as of June 30, 2018 and December 31, 2017, respectively
  -   - 
         
Series E convertible preferred stock, $0.01 par value; $5,000 liquidation preference; 3,500 shares authorized; 3,490 and 0 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively  35   - 
         
Common stock, $0.006 par value; 180,000,000 shares authorized, 11,241,684 and 10,521,728 shares issued and outstanding  as of June 30, 2018 and December 31, 2017, respectively  64,700   63,127 
Additional paid-in capital  26,374,371   8,413,823 
Accumulated deficit  (14,308,644)  (8,028,707)
         
Total stockholders’ equity  12,130,462   448,243 
         
Total liabilities and stockholders’ equity $14,467,928  $6,183,746 
  

For the Three Months Ended

March 31,

 
  2019  2018 
       
Net sales $2,881  $- 
Cost of sales  116,933   - 
Gross loss  (114,052)  - 
         
Operating expenses        
         
Sales, marketing and commercial operations 1,059,222  - 
Research and development  -   173,256 
General and administrative  1,367,303   919,908 
Amortization  17,575   123,261 
Total operating expenses  2,444,100   1,216,425 
         
Loss from operations  (2,558,152)  (1,216,425)
         
Other expense        
         
Interest expense  -   (144,744)
   -   (144,744)
         
Loss before provision for income taxes  (2,558,152)  (1,361,169)
         
Provision for income taxes  -   - 
         
Net loss  (2,558,152)  (1,361,169)
         
Preferred Stock Dividends  (381,686)  - 
         
Net Loss Applicable to Common Stockholders $(2,939,838) $(1,361,169)
         
Net loss Per Share - Common Stockholders - basic and diluted $(0.27) $(0.13)
         
Weighted average shares outstanding- basic and diluted  10,761,684   10,521,278 

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

ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

  Series E Preferred Stock  Series F Preferred Stock  Common Stock  

Additional

  

Additional

Paid-in

      
  Number  Par
Value
  Number  Par
Value
  Number  Par
Value
  

Paid-in

Capital

  

Capital -

Warrants

  

Accumulated

Deficit

  Total 
                               
Balance, December 31, 2017        -  $      -        -  $      -   10,521,278  $63,127  $8,413,823  $          -  $(8,028,707) $448,243 
                                         
Share based compensation  -   -   -   -   -   -   118,879   -   -   118,879 
                                         
Net loss  -   -   -   -   -   -   -   -   (1,361,169)  (1,361,169)
                                         
Balance, March 31, 2018  -  $-   -  $-   10,521,278  $63,127  $8,532,702  $-  $(9,389,876) $(794,047)

  Series E Preferred Stock  Series F Preferred Stock  Common Stock  

Additional

  

Additional

Paid-in

  

   
  Number  Par
Value
  Number  Par
Value
  Number  Par
Value
  

Paid-in

Capital

  

Capital -

Warrants

  

Accumulated

Deficit

  Total 
Balance, December 31, 2018  3,488  $    35   381  $       3   10,761,684  $64,570  $(5,383,913) $34,093,829  $(25,847,805) $2,926,719 
                                         
Accrued dividend  -   -   -   -   -   -   -   -   (381,686)  (381,686)
                                         
Share based compensation  -   -   -   -   -   -   395,390   -   -   395,390 
                                         
Net loss  -   -   -   -   -   -   -   -   (2,558,152)  (2,558,152)
                                         
Balance, March 31, 2019  3,488  $35   381  $3   10,761,684  $64,570  $(4,988,523) $34,093,829  $(28,787,643) $382,271 

 

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

 

35

 

 

MARINA BIOTECH,ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSCASH FLOWS

(Unaudited)

 

  For the Three Months Ended  For the Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
             
Operating expenses            ��   
                 
Sales, marketing and commercial operations $2,585,945  $-  $2,585,945  $- 
Research and development  -   439,894   173,256   513,325 
General and administrative  1,059,088   402,794   1,978,996   1,198,238 
Amortization  123,262   106,226   246,523   204,604 
Total operating expenses  3,768,295   948,914   4,984,720   1,916,167 
                 
Loss from operations  (3,768,295)  (948,914)  (4,984,720)  (1,916,167)
                 
Other expense                
                 
Interest expense  (5,156)  (15,621)  (149,900)  (27,274)
Change in fair value liability of warrants  -   (10,715)  -   (113,787)
Loss on settlement  (874,697)  -   (874,697)  - 
Change in fair value of derivative liability  -   (195,943)      (195,943)
   (879,853)  (222,279)  (1,024,597)  (337,004)
                 
Loss before provision for income taxes  (4,648,148)  (1,171,193)  (6,009,317)  (2,253,171)
                 
Provision for income taxes  -   -   -   800 
                 
Net loss $(4,648,148) $(1,171,193) $(6,009,317) $(2,253,971)
                 
Net loss per share – basic and diluted $(0.43) $(0.12) $(0.56) $(0.24)
                 
Weighted average shares outstanding  10,821,230   9,733,078   10,672,082   9,567,998 

  For the Three Months Ended March 31, 
  2019  2018 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(2,558,152) $(1,361,169)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  395,390   118,879 
Amortization of intangibles  17,575   123,261 
Depreciation  2,922   - 
Non-cash interest expense  -   144,744 
Non-cash lease expense  30,938   - 
Deferred revenue  -   200,000 
Changes in operating assets and liabilities:        
Accounts receivable  8,901   - 
Inventory  (16,549)  - 
Prepaid expenses and other assets  (22,035)  (80,571)
Accounts payable  52,495   428,906 
Accrued expenses  4,862   47,816 
Due to related party  24,681   319,524 
Lease liability  (30,842)  - 
         
Net Cash Used in Operating Activities  (2,089,814)  (58,610)
         
Net decrease in cash  (2,089,814)  (58,610)
         
Cash – Beginning of Period  3,918,290   106,378 
Cash - End of Period $1,828,476  $47,768 
         
Non-cash Investing and Financing Activities:        
Capitalization of operating lease right of use asset $239,768  $- 
Accrued dividends $381,686  $- 

 

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

 

46

 

 

MARINA BIOTECH,ADHERA THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS OF SHAREHOLDERS' EQUITY

(Unaudited)

           Additional       
  

SeriesE

Preferred Stock

  Common Stock  

Additional

Paid-in

  

Paid-in

Capital -

  Accumulated     
  Number  Par Value  Number  Par Value  Capital  Warrants  Deficit  Total 
                         
Balance, December 31, 2017  -  $-   10,521,278  $63,127  $8,413,823     $(8,028,707) $448,243 
                                 
Issuance of Series E Preferred Stock, net of fees  2,812   28        $12,258,197         12,258,225 
                                 
Warrants issued with Series E Preferred Stock              (31,106,896)  31,106,896       
                                 
Issuance of Series E Preferred for debt and accounts payable  687   7         3,437,728         3,437,735 
                                 
Conversion of Series C Preferred stock for common stock        433,334                 
                                 
Conversion of Series D Preferred stock for common stock        25,000                 
                                 
Warrants issued for settlement of liability                 1,494,469      1,494,469 
                                 
Shares issued for settlement of litigation        210,084   1,261   248,739         250,000 
                                 
Shares issued for License Agreement        51,988   312   74,688         75,000 
                                 
Accrued dividend                    (270,620)  (270,620)
                                 
Share based compensation              493,038         493,038 
                                 
Cancellation of Series E Preferred Stock  (9)           (46,311)        (46,311)
                                 
Net loss                    (6,009,317)  (6,009,317)
                                 
Balance, June 30, 2018  3,490  $35   11,241,684  $64,700  $(6,226,994) $32,601,365  $(14,308,644) $12,130,462 

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

5

MARINA BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

  

For the Six Months Ended

June 30,

 
  2018  2017 
       
Cash Flows Used in Operating Activities:        
         
Net loss $(6,009,317) $(2,253,971)
Adjustments to reconcile net loss to net cash used in operating activities:        
Share based compensation  493,038   88,968 
Common shares issued to third party for services  -   54,000 
Common shares issued for settlement  250,000   - 
Preferred shares issued for note settlement  375,000   - 
Common shares issued to license agreement  75,000   - 
Amortization of intangibles  246,523   204,604 
Amortization of debt discount  113,171   - 
Depreciation  438   - 
Non-cash interest expense  36,729   - 
Loss on settlement  874,697     
Change in fair value liabilities for price adjustable warrants  -   113,787 
Change in fair value of derivative liability  -   195,943 
Changes in operating assets and liabilities:        
Inventory  (79,767)  - 
Prepaid expenses and other assets  (193,128)  41,374 
Accounts payable  161,265   330,351 
Accrued expenses  (329,357)  298,491 
Accrued fee  (320,000)  - 
Deferred revenue  200,000   - 
Due to related party  249,565   193,966 
         
Net Cash Used in Operating Activities  (3,856,143)  (732,487)
         
Cash Flows Used in Investing Activities:        
Purchase of furniture and fixtures  (10,504)  - 
Purchase of intangible assets  -   (300,000)
         
Net Cash Used in Investing Activities  (10,504)  (300,000)
         
Cash Flows Provided By Financing Activities:        
         
Proceeds from sale of preferred stock, net offering expenses  12,258,225   - 
Proceeds from sale of common stock to related party  -   250,000 
Proceeds from notes payable due to related party  -   80,410 
Proceeds from convertible notes  -   400,000 
Proceeds from convertible notes due to related parties, net  -   290,000 
Proceeds from exercise of warrants for common stock  -   170,643 
Payments for notes payable  (143,834)  - 
         
Net Cash Provided by Financing Activities  12,114,391   1,191,053 
         
Net increase in cash  8,247,744   158,566 
         
Cash – Beginning of Period  106,378   105,347 
Cash - End of Period $8,354,122  $263,913 
         
Supplementary Cash Flow Information:        
Income taxes paid $-  $800 
         
Non-cash Investing and Financing Activities:   ,     
Issuance of warrants for liabilities, related party $1,494,469  $- 
Common stock issued for accounts payable $-  $947,714 
Return of common stock for note receivable $-  $31,404 
Adjustment to goodwill $-  $55,247 
Preferred share settlement of debt and accrued liabilities $3,437,735  $- 
Issuance of warrants $31,106,896  $- 
Accrued dividends $270,620  $- 

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

6

MARINA BIOTECH, INC.

Notes to Condensed Consolidated Financial Statements

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2018MARCH 31, 2019

(Unaudited)

 

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

 

Business Overview

 

Adhera Therapeutics, Inc. (formerly known as Marina Biotech, Inc.) and its wholly-owned subsidiaries, MDRNA Research, Inc. (“MDRNA”), Cequent Pharmaceuticals, Inc. (“Cequent”), Atossa Healthcare, Inc. (“Atossa”), and IthenaPharma,IThenaPharma, Inc. (“Ithena”IThena”) (collectively “Marina,“Adhera,” the “Company,” “we,” “our,” or “us”) is a fully integrated, commercial stagean emerging specialty pharmaceutical company delivering proprietary drug therapeuticsthat leverages innovative distribution models and technologies to improve the quality of care for significant unmet medical needspatients in the U.S., EuropeUnited States suffering from chronic and certain additional international markets. Our portfolio of products currently focusesacute diseases. We are focused on fixed dose combinationscombination (“FDC”) therapies in hypertension, arthritis, pain and oncology allowing for innovative solutionswith plans to such unmet medical needs. Itsexpand the portfolio of drugs we commercialize to include other therapeutic areas.

Our mission is to provide effective and patient centric treatment for hypertension – includingand resistant hypertension. In this connection, we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certainhypertension while actively seeking additional assets that can be commercialized through our proprietary Total Care System (“TCS”). At the core of the intellectual property assets related to theour TCS system is DyrctAxess, our patented technology platform known asplatform. DyrctAxess also called Total Care, that offersis designed to offer enhanced efficiency, control and access to the information necessary to empower patients, physicians and manufacturers to help achieve optimal care.

 

In doing so,We began marketing Prestalia®, a single-pill FDC of perindopril arginine (“perindopril”) and amlodipine besylate (“amlodipine”) in June of 2018. By combining Prestalia, DyrctAxess and an independent pharmacy network, we have created a universal platformproprietary system for drug adherence and the effective treatment of hypertension, as well as forimproving the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia® (Prestalia), andPrestalia, as well as improving the other products in our pipeline,distribution of devices for therapeutic drug monitoring (“TDM”) (e.g., blood pressure and other cardiac monitors,monitors), as well as services such aspatient counseling and prescription reminders.

reminder services. We currently have oneare focused on demonstrating the therapeutic and commercial and three clinical development programs underway: (i)value of TCS through the commercialization of Prestalia. Prestalia was developed in coordination with Les Laboratories, Servier, a single-pill FDC of perindopril argentine (perindoprol), an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine besylate (amlodipine), a calcium channel blocker (“CCB”), which has beenFrench pharmaceutical conglomerate, that sells the formulation outside the United States under the brand names Coveram® and/or Viacoram®. Prestalia was approved by the U.S. Food and Drug Administration (“FDA”) in January 2015 and is marketeddistributed through our DyrctAxess platform which, we acquired in the U.S.; (ii)2017.

We have discontinued all significant clinical development and are evaluating disposition options for all of our development assets, including: (i) 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)IT-103; (ii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (“FAP”); and (iv)Polyposis; (iii) CEQ508 combined with IT-103 to treat Colorectal Cancer.Cancer; (iv) CEQ608 and CEQ609, an oral delivery of IL-6Ra tkRNAi against irritable bowel disease (IBD) gene targets, which could significantly reduce colon length and abolish the IL-6Rα message in proximal ileum; (v) Claudin-2 strains which (CEQ631 and CEQ632) significantly reduce Claudin-2 mRNA expression and protein levels in the colon as well as attenuation of the disease phenotype and enhance survival; (vi) MIP3a therapeutic strains CEQ631 and CEQ632 which also resulted in a significant reduction in sum pathology scores and reduction in MIP3a mRNA expression. We plan to license or divest these development assets since they no longer align with our focus on the treatment of hypertension.

As our strategy is to be a commercial pharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, while continuing to develop our technology platform and TCS. We intend to create value through the expanded commercialization of our FDA-approved product, Prestalia, while continuing to develop and leverage our TCS to further strengthen our commercial presence.

 

On November 15, 2016, MarinaAdhera entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among IthenaPharma,IThenaPharma, Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of MarinaAdhera (“Merger Sub”), and Vuong Trieu asa representative of the stockholders of IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”).

As reported in our Annual Report on Form 10-K, in AprilIn the second quarter of 2018, we raised in excess of $10approximately $12.2 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 Stock Private Placement Offering below). Further, in MayStock. In July and November 2018, we raised an additional $2 million, net of fees and expenses, from the private placement. In July 2018, we raised $1.4approximately $1.7 million net of fees and expenses, from a private placement of our newly created Series F Convertible Preferred Stock. The use of funds from the private placement will be onraises was used for the commercialization of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and other general corporate requirements. For the development of IT-102 and 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 pharmaceutical assets and halt any other development programs, since they no longer align with our focus on the treatment of hypertension.

7

Change of Company Name and OTC Markets Symbol

In July

On October 4, 2018, we entered into Subscription Agreementsfiled a Certificate of Amendment to our Restated Certificate of Incorporation with certain accredited investors and conducted a closing pursuantthe Secretary of State of the State of Delaware to which we sold 308 shareschange our name from “Marina Biotech, Inc.” to “Adhera Therapeutics, Inc.” The change of our Series F convertible preferred stock at a purchase price of $5,000 per share. See Notename was effective October 9, – Subsequent Events.2018.

 

We intendFollowing the name change from Marina Biotech, Inc. to createAdhera Therapeutics, Inc., our common stock, par value through$0.006 per share, began trading on the commercializationOTCQB tier 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 pharmaceutical 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.OTC Markets under the symbol “ATRX”.

 

Reverse Stock Split

 

In August 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 condensed consolidated financial statements and Notes to the Condensed 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 pursuant to Form 10-Qthe rules and Article 8regulations of Regulation S-X.the Securities and Exchange Commission. 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 informationThis quarterly report should be read in conjunction with the audited consolidated financial statements includingin the notes thereto, as of andCompany’s Annual Report on Form 10-K for the year ended December 31, 2017, included in our 2017 Annual Report on Form 10-K filed with the SEC.2018. 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 sixthree months ended June 30, 2018March 31, 2019 are not necessarily indicative of the results for the year ending December 31, 20182019 or for any future period.

 

Principles of Consolidation

 

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

Going Concern and Management’s Liquidity Plans

The accompanying condensed consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At March 31, 2019, we had a significant accumulated deficit of approximately $28.8 million and negative working capital of approximately $0.1 million. For the three months ended March 31, 2019, we had a net loss from operations of approximately $2.6 million and negative cash flows from operations of approximately $2.1 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, cash generated from the out-licensing or sale of our licensed assets and, to a lesser extent, equipment financing facilities and secured loans. We will need to raise additional operating capital during the second quarter of 2019 in order to maintain our operations and realize our business plan. Without additional sources of cash and/or deferral, reduction, or elimination of significant planned expenditures, we may not have the cash resources to continue as a going concern thereafter. 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 and May 2018, we raised approximately $12.2 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 July 2018, we raised an additional $1.4 million net proceeds from the private placement of our Series F Convertible Preferred Stock. On November 9, 2018, we sold 73 shares of our Series F Preferred Stock for total net proceeds of approximately $0.31 million. For our assessment as of March 31, 2019, we have considered the amount raised and we will continue to reassess our ability to address the going concern. We will continue to attempt to obtain future financing or engage in strategic transactions which may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional equity or debt financing, or whether such actions would generate the expected liquidity as currently planned.

 

Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include revenue and related discounts and allowances, 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.

 

8

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 payableaccounts receivable and accrued liabilitiesexpenses 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. There were no liabilities measured at fair value as of June 30, 2018March 31, 2019 or December 31, 2017.2018.

9

Goodwill and Intangible Assets

The Company periodically reviews the carrying value of intangible assets, including goodwill, to determine whether impairment may exist. Goodwill and certain intangible assets are assessed annually, or when certain triggering events occur, for impairment using fair value measurement techniques. These events could include a significant change in the business climate, legal factors, a decline in operating performance, competition, sale or disposition of a significant portion of the business, or other factors. Specifically, goodwill impairment is determined using a two-step process. The first step of the goodwill impairment test is used to identify potential impairment by comparing the fair value of a reporting unit with its carrying amount, including goodwill. The Company uses level 3 inputs and a discounted cash flow methodology to estimate the fair value of a reporting unit. A discounted cash flow analysis requires one to make various judgmental assumptions including assumptions about future cash flows, growth rates, and discount rates. The assumptions about future cash flows and growth rates are based on the Company’s budget and long-term plans. Discount rate assumptions are based on an assessment of the risk inherent in the respective reporting units. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired and the second step of the impairment test is unnecessary. If the carrying amount of a reporting unit exceeds its fair value, the second step of the goodwill impairment test is performed to measure the amount of impairment loss, if any. The second step of the goodwill impairment test compares the implied fair value of the reporting unit’s goodwill with the carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination. That is, the fair value of the reporting unit is allocated to all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination and the fair value of the reporting unit was the purchase price paid to acquire the reporting unit.

During the year ended December 31, 2018, we determined that goodwill was impaired and, as a result, a loss on impairment of $3.5 million was recognized. The impairment determination was primarily a result of the decision to divest of assets that no longer align with the Company’s strategic objectives.

 

Impairment of Long-Lived Assets

 

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

 

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

 

ManagementDuring the year ended December 31, 2018, the Company determined that nothe intangible asset from the Merger was impaired, and, as a result, a loss on impairment indicators were present andof $1,672,885 was recorded. The impairment determination was primarily a result of the decision to divest of assets that no impairment charges were necessary as of June 30, 2018 or December 31, 2017.longer align with the Company’s strategic objectives.

9

 

Revenue Recognition

 

The Company has adopted the new revenue recognition guidelines in accordance with ASC 606,Revenue from Contracts with Customers(ASC 606), commencingeffective with the quarter ended March 31, 2018.

The Company sells its medicines primarily to wholesale distributors and specialty pharmacy providers. These customers subsequently resell the Company’s medicines to health care patients. In addition, the Company enters into arrangements with health care providers and payers that provide for government-mandated or privately-negotiated discounts and allowances related to the Company’s medicines. Revenue is recognized when performance obligations under the terms of a contract with a customer are satisfied. The majority of the Company’s contracts have a single performance obligation to transfer medicines. Accordingly, revenues from medicine sales are recognized when the periodcustomer obtains control of the Company’s medicines, which occurs at a point in time, typically upon delivery to the customer. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring medicines and is generally based upon a list or fixed price less allowances for medicine returns, rebates and discounts. The Company sells its medicines to wholesale pharmaceutical distributors and pharmacies under this report.agreements with payment terms typically less than 90 days.

During the year ended December 31, 2018, management determined certain costs related to the sales of Prestalia, specifically, costs associated with free product, should be classified as cost of goods sold and not revenue reductions. Consistent with the accounting for the year ended December 31, 2018, the Company recorded an estimate of unrealized revenue reductions, and the related liability, for bottles sold to pharmacies but not yet prescribed.

Medicine Sales Discounts and Allowances

The nature of the Company’s contracts gives rise to variable consideration because of allowances for medicine returns, rebates and discounts. Allowances for medicine returns, rebates and discounts are recorded at the time of sale to wholesale pharmaceutical distributors and pharmacies. The Company applies significant judgments and estimates in determining some of these allowances. If actual results differ from its estimates, the Company will be required to make adjustments to these allowances in the future. The Company’s adjustments to gross sales are discussed further below.

Distribution Service Fees

The Company includes distribution service fees paid for inventory management services as cost of good sold. The Company calculates accrued distribution service fee estimates using the most likely amount method. The Company accrues estimated distribution fees based on contractually determined amounts. Accrued distribution service fees are included in “accrued expenses” on the condensed consolidated balance sheet.

Patient Access Programs

 

The Company analyzesoffers discounts to patients under which the patient receives a discount on his or her prescription. In circumstances when a patient’s prescription is rejected by a third-party payer, the Company will pay for the full cost of the prescription. The Company reimburses pharmacies for this discount directly or through third-party vendors. The Company reduces gross sales by the amount of actual co-pay and other patient assistance in the period based on the invoices received. The Company also records an accrual to reduce gross sales for estimated co-pay and other patient assistance on units sold to distributors or pharmacies that have not yet been prescribed/dispensed to a patient. The Company calculates accrued co-pay and other patient assistance fee estimates using the expected value method. The estimate is based on contract prices, estimated percentages of medicine that will be prescribed to qualified patients, average assistance paid based on reporting from the third-party vendors and estimated levels of inventory in the distribution channel. Accrued co-pay and other patient assistance fees are included in “accrued expenses” on the condensed consolidated balance sheet. Patient assistance programs include both co-pay assistance and fully bought down prescriptions.

Sales Returns

Consistent with industry practice, the Company maintains a return policy that allows customers to return medicines within a specified period prior to and subsequent to the medicine expiration date. Generally, medicines may be returned for a period beginning six months prior to its contractsexpiration date and up to assessone year after its expiration date. The right of return expires on the earlier of one year after the medicine expiration date or the time that they arethe medicine is dispensed to the patient. The majority of medicine returns result from medicine dating, which falls within the scoperange set by the Company’s policy and in accordance with ASC 606. In determiningare settled through the appropriate amountissuance of revenuea credit to be recognized asthe customer. The Company calculates sales returns using the expected value method. The estimate of the provision for returns is based upon industry experience. This period is known to the Company fulfillsbased on the shelf life of medicines at the time of shipment. The Company records sales returns in “accrued expenses” and as a reduction of revenue.

11

Shipping Fees

The Company includes fees incurred by pharmacies for shipping medicines to patients as cost of good sold. The Company calculates accrued shipping fee estimates using the expected value method. The Company records accrued shipping fees in “accrued expenses” on the condensed consolidated balance sheet.

Customers Concentration

The Company sells its obligations under each of its agreements, whetherprescription drug (Prestalia) directly to specialty contracted retail pharmacies and indirectly through wholesalers. For the three months ended March 31, 2019, the Company’s three largest customers accounted for goodsapproximately 56%, 26%, and services or licensing, the Company performs the following steps: (i) identification18%, respectively, of the promised goodsCompany’s total gross sales. The Company works with a third-party pharmacy network manager to attract, retain, and manage the Company’s pharmacy customers and distribution channels. All of 2019 gross sales were made to customers associated with 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 pricerelated to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as)Company’s third-party pharmacy network manager. The Company had no significant sales for the Company satisfies each performance obligation.three months ended March 31, 2018.

 

In terms of licensingLicensing Agreements

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.

10

During the three months ended June 30, 2018, the Company entered into certain contracts for the sale and distribution of Prestalia and shipped orders totaling approximately $58,000. The Company has not recognized this revenue since it cannot yet determine that collectability of the entire amount is probable.

During the three monthsyear ended MarchDecember 31, 2018, MarinaAdhera entered into a Licensing Agreement, whereby MarinaAdhera granted exclusive rights to the company’sCompany’s DiLA2delivery system in exchange for an upfront payment of approximately $200,000 and further potential future consideration dependent upon event and sales-based milestones. Under the terms of the agreement, MarinaAdhera has agreed to assign ownership of the intellectual property associated with the DiLA2 delivery system to the purchaser. The Company has yet tonot completed, and will not complete, certain performance obligations under the agreement and accordingly has deferredclassified the recognition$200,000 payment in accrued expenses as of revenue from the sale of the asset until such obligations are fulfilled.March 31, 2019 and December 31, 2018.

 

Recently Issued Accounting Pronouncements

 

In May 2014,February 2016, the FASB issued ASU 2014-09, Revenue from Contracts with CustomersNo. 2016-02, Leases (Topic 606)842) (“ASU No. 2016-02”). Under ASU No. 2016-02, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. For leases with a term of twelve months or less, the provisionslessee is permitted to make an accounting policy election not to recognize lease assets and lease liabilities by class of underlying assets. 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 isNo. 2016-02 becomes effective for annual reporting periodsthe Company beginning after December 15, 2017.in the first quarter of 2019. The guidance can be applied using either a modified retrospective approach at the beginning of the earliest period presented, or at the beginning of the period in which it is adopted. The Company adopted the provisions of this standard effectiveon January 1, 2018.2019, using a modified retrospective approach at the adoption date through a cumulative-effect adjustment to retained earnings. The adoption did not have a material impact on its condensed consolidated statement of operations. However, the new standard required the Company to establish approximately $0.2 million of liabilities and corresponding right-of-use assets of approximately $0.2 million on its condensed consolidated balance sheet for operating leases on rented office properties that existed as of the January 1, 2019, adoption date. The Company elected to not recognize lease assets and liabilities for leases with an initial term of twelve months or less.

12

 

Net Income (Loss) per Common Share

 

Basic net income (loss) per common share (after giving effect of the one for ten reverse stock split)split that became effective in August 2017) 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 (loss) since such inclusion would be anti-dilutive:

 

 Three and Six Months Ended June 30,  Three Months Ended March 31, 
 2018 2017  2019  2018 
          
Stock options outstanding  1,122,457   233,400   4,522,807   764,707 
Warrants  33,028,829   2,492,945   36,267,329   2,548,481 
Shares to be issued upon conversion of notes payable  -   312,050   -   323,404 
Restricted common stock  -   70,000 
Series E Preferred Stock  34,880,000   - 
Series F Preferred Stock  3,810,000   - 
Total  34,151,286   3,108,395   79,480,136   3,636,592 

 

Reclassification of Prior Period PresentationNOTE 2 – Inventory

 

Certain priorInventory consists of raw material and finished goods stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis. The Company reviews the composition of inventory at each reporting period amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported resultsin order to identify obsolete, slow-moving, quantities in excess of operationsexpected demand, or cash flows.otherwise non-saleable items.

 

11

Inventory consisted of the following as of March 31, 2019 and December 31, 2018:

 

  March 31, 2019  December 31, 2018 
       
Raw Materials $84,618  $147,139 
Finished Goods  173,389   94,319 
Inventory, Net $258,007  $241,458 

NOTE 3 – PREPAID AND OTHER ASSETS

Prepaid expenses and other assets at March 31, 2019 and December 31, 2018 included prepaid insurance of $163,777 and $179,145, respectively, and deposits with third-party co-pay program managers of $143,795 and $157,584, respectively. The deposits with co-pay program managers are used to fund patient’s insurance co-pay support, for a specified period of time, with any unused amounts refunded to the Company.

 

Note 2 –4 - Intangible Assets

 

Acquisition of Prestalia & Dyrct AxessDyrctAxess

 

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 $620,000 (consisting of $300,000 in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $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 agreedtransferred 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 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 had beenwas allocated based on a preliminary estimate of the fair value of the assets acquired and iswas included in intangible assets as of December 31, 20172017. During the year ended December 31, 2018, the allocation of the purchase price was finalized which resulted in $160,800 of the price being allocated to raw materials received from Symplmed, and June 30, 2018. No subsequent adjustments were deemed necessary by the Company.remaining $459,200 being allocated to intangible assets.

 

Further, we hired our currenta Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective in June 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 vesting on the six (6) month anniversary of the date of grant. These shares were fully vested on December 31, 2017. This Chief Commercial Officer resigned in January 2019.

 

In furtherance of the acquisition and commercialization of Prestalia, in July 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 for $75,000 in cash.

 

Intangible Asset Summary

The following table summarizes the estimated fair valuebalances as of March 31, 2019, of the identifiable intangible assetassets acquired, their useful life, and method ofannual amortization:

 

 

Estimated

Fair Value

 

Estimated

Useful Life

(Years)

 

Annual

Amortization

Expense

  

Net Book Value

March 31, 2019

 

Remaining

Estimated
Useful Life
(Years)

  Annual
Amortization
Expense
 
Intangible asset from the Merger $2,361,066   6.0  $393,511 
       
Intangible asset - Prestalia  620,000   6.6   94,177  $308,469   4.76  $64,941 
Intangible asset – DyrctAxess  75,000   14.0   5,357 
Intangible asset - DyrctAxess  65,848   12.34   5,357 
Total $3,056,066      $493,045  $374,317      $70,298 

 

The netDuring the year ended December 31, 2018, we determined that the intangible asset from the merger was $2,309,451, netimpaired, and as a result, we recognized a loss on impairment of accumulated amortization$1,672,885. The impairment determination was primarily a result of $746,615, asthe decision to divest of June 30, 2018. assets that no longer align with the Company’s strategic objectives.

Amortization expense was $246,523$17,575 and $204,604 for the six months ended June 30, 2018 and 2017, respectively, and $123,262 and $106,226$123,261 for the three months ended June 30,March 31, 2019 and 2018, and 2017, respectively.

 

Note 35 - Related Party Transactions

 

Due to Related Party

 

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

The Company hashad a Master Services Agreement (“MSA”) with Autotelic Inc., a related party that is partly-owned by one of the Company’s former Board members and executive officers, namely Vuong Trieu, Ph.D., effective November 15, 2016. Autotelic Inc. currently owns less than 5% of the Company. The MSA statesstated that Autotelic Inc. will provide business functions and services to the Company and allowsallowed Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includesincluded 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 requiresrequired a 90-day written termination notice in the event either party requires to terminate such services. In August 2018, we have notifiedWe and Autotelic that we are terminating the services underInc. agreed to terminate the MSA and that such services would end oneffective October 31, 2018. Dr. Trieu resigned as a director of our company effective October 1, 2018.

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During the period commencing November 15, 2016 (the “Effective Date”) and ending on the date that the Company hashad 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 paypaid 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 arewere issued. The Company shall also paypaid Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share will bewas calculated based on the Black-Scholes model.

 

After the Equity Financing Date, the Company shall paypaid 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”).Controls.

 

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 sixthree months ended June 30,March 31, 2019 and 2018, and 2017, Autotelic Inc. billed a total of $616,385$0 and $317,044,$256,997, respectively, including personnel costs of $284,091$0 and $243,944,$133,633, respectively. An unpaid balance of $64,478$4,392 and $730,629$4,392 is included in due to related party in the accompanying balance sheetsheets as of June 30, 2018March 31, 2019 and December 31, 2017,2018, respectively.

 

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 Series E Preferred Stock to settle accounts payable of $812,967 and Warrants to purchase up to 1,219,4251,345,040 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount of approximately $812,950,$739,772, and other liabilities, owed to Autotelic Inc. as of March 31, 2018 pursuant to the MSA. The Securitiessecurities that were issued to Autotelic Inc., which were issued upon the closing of the offering described above, have the same terms and conditions as the Securitiessecurities that were issued to investors in the offering (See Note 5)6). SuchThe warrants have a five-year term, an exercise price of $0.55. In addition, we issued 1,345,040 warrants to purchase shares of common stock to Autotelic to satisfy a liability to issue warrants as of March 31, 2018. Such warrants have a five-year term, aninitial exercise price of $0.55, and have a fair value of $1,494,469 resulting in a loss on settlement of debt of $754,697.

 

Resignation and Appointment of Officer and DirectorsTransactions with BioMauris, LLC/Erik Emerson

 

On April 27, 2018, our Board of Directors (the “Board”) increased the size of the entire Board from five (5) directors to seven (7) directors, and it appointed each of Erik Emerson and Tim Boris to fill the vacancies created thereby.

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.

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, a director of the Company and former Executive Chairman, to serve as our Interim Chief Executive Officer, to replace Mr. Ramelli, effective with Mr. Ramelli’s departure. In his capacity as Interim Chief Executive Officer, Dr. Trieu received a salary in the amount of $20,000 per month. Dr. Trieu resigned from the position of Interim Chief Executive Officer on June 18, 2018.

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On June 18, 2018, the Board appointed Robert C. Moscato, Jr., to serve as our Chief Executive Officer effective immediately. In connection with the appointment of Mr. Moscato as Chief Executive Officer, Dr. Trieu resigned as Interim Chief Executive Officer, and also from his position as Executive Chairman of our company, effective immediately.

On June 18, 2018, the Board appointed Uli Hacksell, Ph.D.to serve as a member of the Board, and as Chairman of the Board, effective July 1, 2018. Dr. Hacksell agreed to devote half of his business time to Marina.

On June 28, 2018, the Board appointed Mr. Moscato to serve as a member of the Board, effective July 1, 2018.

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 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 of our private placement described above, have the same terms and conditions as the Securities that were issued to investors in the offering.

Transactions with BioMauris, LLC

During the sixthree months ended June 30,March 31, 2019 and 2018, the companywe paid a total of $309,116$21,690 and $46,532, respectively, for services provided by BioMauris, LLC, of which Erik Emerson, our former Chief Commercial Officer and a current director of Marina,Adhera, is Executive Chairman. A total of $33,016$48,266 and $23,585 was due to BioMauris, LLC as of June 30, 2018.March 31, 2019 and December 31, 2018, respectively, and is included in due to related party on the accompanying balance sheets.

 

Note 4 – Notes Payable

Following is a breakdown of notes payable as of June 30, 2018 and December 31, 2017:

  June 30, 2018  December 31, 2017 
       
Notes payable $-  $97,523 
Convertible notes payable  -   346,700 
Total notes payable $-  $444,223 
         
Notes payable – related parties  -  $93,662 
Convertible notes payable – related parties (net of debt discount of $0 and $113,171 as of June 30, 2018 and December 31, 2017, respectively)  -   1,368,378 
Total notes payable – related parties $-  $1,462,040 

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Note Payable – Service ProviderOption Grant for Former Chief Financial Officer

 

In December 2016, we entered into

On January 15, 2019, our Board of Directors (the “Board”) granted to our CFO options to purchase up to an Agreement and Promissory Note with a law firm for past services performed totaling $121,523. The note called for monthly paymentsaggregate of $6,000 per month, beginning with an initial payment on March 31, 2017. The note was unsecured and non-interest bearing. The note was paid in full in May 2018. The balance due on the note was $0 and $97,523 as of June 30, 2018 and December 31, 2017, respectively.

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 “2016 Notes”). Interest accrued on the unpaid principal balance of the 2016 Notes at the rate of 12% per annum beginning on September 20, 2016. The 2016 Notes were due and payable on June 20, 2017.

In July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to those 2016 Notes and the warrants to purchase100,000 shares of our common stock that are currently held by the Purchasersat an exercise price of $0.32 per share, with 25,000 options being exercisable immediately 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, Cequent and the purchasers identifiedwith 25,000 options vesting on the signature pages thereto (as amended from time to time), to, among other things, extend the maturity dateeach of the 2016 Notes to December 31, 2017, to provide for the issuance of consideration securities at a cost of $375,000 (“Consideration Securities”)first, second and to extend the price protection applicable to certainthird anniversary 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 2016 Notes.

In April 2018, and in connection with the closing of our private placement on thatgrant date we issued to the holders (such holders, the “June 2016 Noteholders”) 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.

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.

As of June 30, 2018 and December 31, 2017, the accrued interest expense on the Notes amounted to $0 and $46,700, respectively, with a total balance of principal and interest of $0 and $346,700, respectively.

Bridge(See Note Financing

In June 2017, we issued convertible promissory notes (the “2017 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 2017 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)7). Our then Executive Chairman and our Chief Science Officer were each investors in the 2017 Notes.

Upon written notice delivered to us by the holders of a majority in interest of the aggregate principal amount of 2017 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 2017 Notes, the Majority Holders shall have the right, but not the obligation, on behalf of themselves and all other holders of 2017 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 2017 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.

 

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AsResignation of June 30, 2018 and December 31, 2017, the accrued interest expense on the 2017 Notes amounted to $0 and $11,365, with a total balance of principal and interest of $0 and $411,365, respectively, and is included in notes payable – related parties on the accompanying balance sheet.Chief Commercial Officer

 

On January 15, 2019, the Board accepted the resignation of our Chief Commercial Officer (our “former CCO”), effective immediately. He will remain as a member of the Board. Simultaneous with his resignation as our CCO, we and our former CCO entered into a Consulting Agreement dated as of January 15, 2019 pursuant to which our former CCO agreed to provide certain consulting services regarding our FDA-approved Prestalia product for a fee of $3,000 per month. During the three months ended March 31, 2019, the Consulting Agreement was terminated.

In

Resignation of Chief Financial Officer

On March 11, 2019, our CFO submitted his resignation as our CFO and from any other positions that he may hold with our company or any of its subsidiaries, effective March 22, 2019.

Resignation and Appointment of Chief Executive Officer

On April 2018,4, 2019, the Company appointed Nancy R. Phelan, to serve as CEO and inSecretary of the Company, effective immediately. In connection with the closing ofappointment Ms. Phelan as our private placement on that date, we issued to the holders (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 Stocknew CEO and Warrants to purchase up to 505,705 shares of common stock, (of which 9.27 shares were subsequently cancelledSecretary, Robert C. Moscato, Jr. resigned from such positions, and paid to such holders an aggregate of $46 thousand in cash)also from his position 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 2017 Notes and the issuance of the Securities to the June 2016 Noteholders (and payment of cash), the entire unpaid principal balance of the 2017 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.

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).

In November 2017, the Company issued a convertible promissory note with a related party (a trust affiliated with Isaac Blech, a member of ourthe Board of Directors) for $500,000 (the “Blech Note”), with annual interest at 8%, maturing on March 31, 2018, and convertible at the price equal to any financing transaction involving the sale byDirectors of the Company of its equity securities yielding aggregate gross proceeds to the Company of not less than $5 million. 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.effective immediately.

In April 2018, and in connection with the closing of our private placement on that date, we issued to the trust 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 the Blech Note in the original principal amount of $500,000. 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.

The Blech 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 six months ended June 30, 2018, with a remaining unamortized value of $0. Total principal and interest was $0 and $504,274 as of June 30, 2018 and December 31, 2017, respectively, and is included in notes payable – related parties on the accompanying balance sheet.

Convertible Notes Payable, Dr. Trieu

 

In connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, a directorour appointment of the Company andMs. Phelan as our former Executive Chairman and Interim CEO, forwe granted her options to purchase an unsecured lineaggregate 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. The line of credit was convertible at any time into1,500,000 shares of the Company’sour common stock, at a price of $1.77 per share.

In April 2018, and in connection with the closing of our private placement on that date, we issued to Dr. Trieu 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 as400,000 are exercisable immediately, 600,000 vest on a monthly basis over a two-year period beginning on April 4, 2020, and 500,000 vest upon the achievement of the date of the closing of our private placement. As such, the Line of Credit was terminated in April 2018. The Securities that were issued to Dr. Trieu have the same termscertain product sales and conditions as the Securities that were issued to investors in the offering.

16

Accrued interest on the Line Letter was $0 and $25,836 as of June 30, 2018 and December 31, 2017, respectively, and is included in notes payable - related parties on the accompanying consolidated balance sheets.

Line Letter with Autotelic, Inc.

In April 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.price targets.

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. As such, in April 2018, the line of credit with Autotelic Inc was terminated. 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.

The balance under the line was $0 and $93,662, including accrued interest of $0 and $2,847 as of June 30, 2018 and December 31, 2017, respectively, and is included in notes payable - related parties on the accompanying consolidated balance sheet.

 

Note 5 –6 - Stockholders’ Equity

 

Preferred Stock

 

MarinaAdhera has authorized 100,000 shares of preferred stock for issuance and has 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, MarinaAdhera designated 1,200 shares as Series C Convertible Preferred Stock (“Series C Preferred”). In August 2015, MarinaAdhera designated 220 shares as Series D Convertible Preferred Stock (“Series D Preferred”). In April 2018, MarinaAdhera designated 3,500 shares of Series E Convertible Preferred Stock.Stock (“Series E Preferred”). In July 2018, MarinaAdhera designated 2,200 shares of Series F Convertible Preferred Stock.Stock (“Series F Preferred”).

 

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Series C Preferred

 

Each shareAs 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,both March 31, 2019 and is convertible into shares of common stock at a conversion price of $7.50 per share. In September 2017, an investor converted 270December 31, 2018, 100 shares of Series C Preferred stock into 180,000 shares of our common stock.remained outstanding.

In June 2018, an investor converted 650 shares of Series C Preferred stock into 433,334 shares of our common stock.

17

 

Series D Preferred

 

In August 2015, Marina entered into a Securities Purchase Agreement with certain investors pursuant to which Marina sold 220As of both March 31, 2019 and December 31, 2018, 40 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 May 2018, an investor converted 20 shares of Series D Preferred into 25,000 shares of common stock.remained outstanding.

 

Series E Convertible Preferred Stock Private Placement

 

In April and May 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 2,812 shares of our Series E convertible preferred stock (the “Preferred Stock”),Preferred, at a purchase price of $5,000 per share of Preferred Stock.Series E Preferred. Each share of Series E 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 Series E Preferred, Stock, the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series E Preferred Stock purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Series E Preferred Stock accrues 8% dividends per annum and are payable in cash or stock at the Company’s discretion. The cumulative dividends are required obligations to be paid each year by the Company. TheSeries E 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 accrued dividends on the Series E Preferred of $344,108 for the three months ended March 31, 2019. No similar dividends were accrued in 2018.

Series F Convertible Preferred Share Private Placement

In July 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 308 shares of our Series F Preferred, at a purchase price of $5,000 per share of Series F Preferred. Each share of Series F Preferred 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 Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. The Series F Preferred accrues 8% dividends per annum and are payable in cash or stock at the Company’s discretion. The Series F Preferred 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 July 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.

 

We received net proceeds of approximately $12.3$1.4 million from the sale of the Preferred Stock,Securities, after deducting placement agent fees and estimated expenses payable by us of approximately $2 million$180,000 associated with such closing. We intend to useused 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 2,958,460308,000 shares of our common stock. The Warrant has a five-year term and an exercise price of $0.55 per share.

We accrued dividends on the Series E Preferred Stock of $270,620 for the three months and six months ended June 30, 2018. No similar dividends were accrued for the same periods of 2017.

Series F Convertible Preferred Share Private Placement Offering

In JulyOn November 9, 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 30873 shares of our Series F convertible preferred stockPreferred Stock, at a purchase price of $5,000 per share of Preferred Stock. Each share of Series F Preferred 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 to purchase 0.75 shares of common stock for each share of common stock issuable upon the conversion of the Series F Preferred purchased by such investor at an initial exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder. We received total net proceeds of approximately $0.31 million from the issuance of the securities described above, after deducting placement agent fees and estimated expenses payable by us associated with such closing. In connection with the private placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 73,000 shares of our common stock. The Warrant has a five-year term and an exercise price of $0.55 per share. See

We accrued dividends on the Series F Preferred of $37,578 for the three months ended March 31, 2019. No similar dividends were accrued in 2018.

Stock Option Grants

During the three months ended March 31, 2019, Mr. Moscato, Mr. Emerson, and Mr. Teague resigned (See Note 95Subsequent Events.Related Party Transactions). All vested options held by Mr. Teague are set to expire 90 days after his resignation date and all vested options held by Mr. Moscato are set to expire 12 months after his resignation date.

During the three months ended March 31, 2019, we granted an aggregate of 135,000 stock options to employees.

 

Common Stock

 

Our common stock currently trades on the OTCQB tier of the OTC Markets under the symbol “MRNA”“ATRX”. We currentlyAs of March 31, 2019, we have 11,241,68410,761,684 shares of our common stock outstanding.

 

Stock Issuances

 

In addition to the common stock issuances described above, weWe issued the following shares of the Company’sno common stock during the sixthree months ended June 30, 2018.

As discussed in Note 7, 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.

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As discussed in Note 8, in April 2018, we entered into a Stipulation of Settlement with Vaya Pharma and issued a total of 210,084 shares of our common stock with a fair value of $250,000.

In May 2018, an investor converted 20 shares of Series D Preferred into 25,000 shares of common stock.

In June 2018, an investor converted 650 shares of Series C Preferred stock into 433,334 shares of our common stock.March 31, 2019.

 

Warrants

 

As of June 30, 2018,March 31, 2019, there were 33,028,82936,267,329 warrants outstanding, with a weighted average exercise price of $0.81$0.79 per share, and annual expirations as follows:

 

Expiring in 2018-
Expiring in 2019  600,000 
Expiring in 2020  1,189,079 
Expiring in 2021  343,750 
Expiring in 2022  29,202,22766,667
Expiring in 202333,729,180 
Expiring thereafter  1,693,773338,653 
Total  33,028,82936,267,329 

The above includes 29,135,560 warrants issued in April and May 2018 in connection with our Series E Preferred Stock offering with a fair value of $31,106,896 which are reflected in additional paid-in capital and additional paid in capital-warrants on the accompanying condensed consolidated statement of stockholder’s equity. The warrants have a five-year term and an exercise price of $0.55. There was no expense related to these warrants.

Additionally, the above includes 1,345,040 warrants issued to Autotelic, Inc. in April 2018 to satisfy accrued and unpaid fees in the aggregate amount of approximately $739,772, and other liabilities, owed to Autotelic Inc. as of March 31, 2018. The warrants have a five-year term, an exercise price of $0.55, and have a fair value of $1,494,469 resulting in a loss on settlement of liability of $754,697.

 

The above includes price adjustable warrants totaling 1,895,013 which are described more fully in our 2017 Annual Report on Form 10-K.34,373,030.

 

A total of 11,131No warrants expired during the sixthree months ended June 30, 2018. 252 warrants have since expired in July 2018.March 31, 2019.

18

 

Note 6 —7 - Stock Incentive Plans

 

Stock Options

 

StockThe following table summarizes stock option activity was as follows:for the three months ended March 31, 2019:

 

  Options Outstanding 
  Shares  Weighted
Average
Exercise Price
 
Outstanding, December 31, 2017  745,707  $8.84 
Options granted  399,000   1.01 
Options expired / forfeited  (22,250)  220.70 
Outstanding, June 30, 2018  1,122,457   1.86 
Exercisable, June 30, 2018  590,519  $1.76 

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  Options Outstanding 
  Shares  Weighted
Average
Exercise Price
 
Outstanding, December 31, 2018  5,613,057  $0.83 
Options granted  135,000   0.31 
Options expired / forfeited  (1,225,250)  1.10 
Outstanding, March 31, 2019  4,522,807   0.86 
Exercisable, March 31, 2019  1,736,414  $      0.90 

 

The following table summarizes additional information on Marina’sAdhera’s stock options outstanding at June 30, 2018:March 31, 2019.

 

   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
 
$0.98   380,000   4.84  $0.98   380,000  $0.98 
$1.00   14,000   3.38  $1.00   14,000  $1.00 
 $1.50 – $1.80   553,007   8.59   1.78   141,069   1.75 
 $2.60 – $8.20   150,400   3.83   2.94   30,400   4.48 
 $10.70 – $22.00   25,050   1.23   10.81   25,050   10.81 
                       
 Totals   1,122,457   6.46  $1.86   590,519  $1.76 
  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 
$0.28 - $0.98  3,875,000   9.85  $0.69   1,567,500  $0.71 
$1.00  7,000   2.63  $1.00   7,000  $1.00 
$1.50 - $1.80  493,207   8.43  $1.79   134,314  $1.78 
$2.60 - $8.20  135,200   3.28  $2.77   15,200  $4.48 
$10.70 - $22.00  12,400   0.46  $10.70   12,400  $10.70 
                     
Totals  4,522,807   8.60  $0.86   1,736,414  $0.90 

 

Weighted-Average Exercisable Remaining Contractual Life (Years) 4.927.93

 

In January 2018,During the Companythree months ended March 31, 2019, we granted a totalan aggregate of 19,000135,000 stock options to directors and officers for services. The options have anemployees at exercise price of $1.56 and a five-year term.

In May 2018, the Company granted a total of 380,000prices ranging from $0.28 to $0.34 per share. 35,000 stock options to directorsvest at a rate of one-third at the end of each annual anniversary over three years from the grant date and officers for services. Thehave a 10-year term. 100,000 options vest at a rate of 25,000 upon grant and 25,000 at the end of each annual anniversary over three years from the grant date and have an exercise price of $0.98 and a five-year term.revised 90 day term based on our former CFO’s resignation.

 

As of June 30, 2018,March 31, 2019, we had $717,996$680,057 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $493,038$395,390 and $59,568 for the six months ended June 30, 2018 and 2017, respectively, and $374,159 and $15,328$118,879 for the three months ended June 30,March 31, 2019 and 2018, and 2017, respectively.

InJuly 2018, we granted our Chief Executive Officer, Robert Moscato Jr. 1,500,000 Incentive Stock Options; Uli Hacksell, Ph.D., the Chairman of our Board, 1,000,000 Incentive Stock Options; and Erik Emerson, our Chief Commercial Officer, 1,125,000 Incentive Stock Options.

 

As of June 30, 2018,March 31, 2019, the intrinsic value of options outstanding or exercisable was $0$15,100 as there were no options outstanding with an exercise price less than $0.63,$0.40, the per share closing market price of our common stock at that date.

 

Note 7 —8 - 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.

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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. 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, with a fair value of $75,000, 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.

Vuong Trieu, Ph.D., one of our Board members, is the Chairman of the Board and Chief Operating Officer of LipoMedics.

In consideration Lipomedics agreed to the following fee schedule: 1) Evaluations License Fee. Simultaneous with the execution and delivery of 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.

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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. Oncotelic has not completed the purchase of the stock and we have not been able to reach to a definitive agreement, as such we have terminated the agreement.

Agreement with Autotelic BIO

On January 11, 2018, we entered into a 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 “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, a current director of the Company and former 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.

License of DiLA2 Assets

 

On March 16, 2018, MarinaAdhera entered into a Licensing Agreement, whereby MarinaAdhera 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, MarinaAdhera has agreed to assign ownership of the intellectual property associated with the DiLA2 delivery system to the purchaser. The Company has yet tonot completed, and will not complete, certain performance obligations under the agreement and accordingly has deferredclassified the recognition$200,000 payment in accrued expenses as of revenue from the sale of the asset until such obligations are fulfilled.March 31, 2019 and December 31, 2018.

 

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Asset Purchase Agreement

 

In July 2017, MarinaAdhera entered into an Asset Purchase Agreement with Symplmed Pharmaceuticals LLC and its wholly-owned subsidiary Symplmed Technologies, LLC (“Sellers”) pursuant to which the Company purchased from the Sellers,sellers, for an aggregate purchase price of $75,000 in cash, certain specified assets of the Sellerssellers relating to the Sellers’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)4).

22

 

Note 8 –9 - 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 our activities, we 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, we are not aware of any pending lawsuits against us, our officers or our directors.

 

Paragraph IV Challenge

Our Prestalia product was involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This challenge, which was pending in the United States District Court for the District of Delaware (No. 1:17-cv-00276), was captionedApotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratoires Servier. The challengers (Apotex Inc. and Apotex Corp. (“Apotex”)) 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 sought a declaratory judgment that no valid claims of the two 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 was designed to provide Apotex with an opportunity to enter the market with a generic version of Prestalia, ahead of the expiration 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 challenge in the second quarter of 2017. Such parties, along with us, have reached an agreement on terms that result in a delay to the challengers’ ability to enter the market with a generic version of Prestalia, while still providing the challenger with the right to enter the market prior to the expiration of the patent covering such product. Specifically, the parties have entered into a Confidential Settlement Agreement in connection with the settlement of the matter, pursuant to which, among other things, the parties entered into a Confidential License Agreement, whereby Symplmed, Servier and our company agreed to grant to Apotex a non-transferable, non-sublicensable, perpetual, irrevocable, royalty-free, non-exclusive license to the two patents listed in the FDA Orange Book as having claims covering Prestalia to make, use and market a generic version of Prestalia, or import a generic version of Prestalia from India into the United States, on or after January 1, 2021.

As a result of the foregoing, the matter is now settled.

Litigation Regarding Vaya Pharma

We 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 had been filed in the Supreme Court of the State of New York, we had not been legally served. The complaint 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) we were liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement we 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. In April 2018, we entered into a Stipulation of Settlement requiring uspursuant to issuewhich we issued to Vaya Pharma 210,084 shares of our common stock with a fair value of $250,000,$250,000.

Leases

We have entered into a Standard Form Office Lease with ROC III Fairlead Imperial Center, LLC, as landlord, pursuant to which shares were issuedwe lease our corporate headquarters located at 4721 Emperor Boulevard, Suite 350, Durham, North Carolina 27703 for a term of 37 months starting on October 1, 2018. Our base monthly rent for such space is currently $6,458, which amount will increase to $7,057 for the final month of the term. Other than the lease for our corporate headquarters, we do not own or lease any real property or facilities that are material to our current business operations. As we expand our business operations, we may seek to lease additional facilities of our own in Aprilorder to support our operational and administrative needs under our current operating plan.

The Company adopted ASU No. 2016-02 on January 1, 2019, using a modified retrospective approach at the adoption date through a cumulative-effect adjustment to retained earnings. The adoption did not have a material impact on its condensed consolidated statement of 2018. We accrued $0operations. However, the new standard required the Company to establish approximately $0.2 million of liabilities and $250,000,corresponding right-of-use assets of approximately $0.2 million on its condensed consolidated balance sheet for operating leases on rented office properties that existed as of June 30, 2018the January 1, 2019, adoption date. The total right-of-use asset was approximately $0.2 million as of March 31, 2019 and December 31, 2017, respectively, and such amount was includedis reflected in accrued expensesthe operating lease right of use asset on the accompanying condensed consolidated balance sheets.sheet. The total related liability was approximately $0.2 million as of March 31, 2019, of which approximately $0.1 million is included in current portion of operating lease liability and approximately $0.1 million is reflected in operating lease liability, net of current portion on the accompanying condensed consolidated balance sheet. The future minimum lease payments as of March 31, 2019 are approximately $0.07 million for the remaining nine months of 2019, $0.08 million for 2020, and $0.07 million for 2021.

 

Note 910 - Subsequent Events

 

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

 

Series F Convertible Preferred Share Private Placement OfferingOn April 4, 2019, we entered into an employment agreement with our new CEO, Nancy R. Phelan, effective immediately, who was also appointed to serve as our Secretary. In connection with the appointment of our new CEO and Secretary, Robert C. Moscato, Jr. resigned from such positions, and also from his position as a member of our Board of Directors effective immediately (See Note 5 – Related Party Transactions).

 

In July 2018,April 2019, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which we sold 308 shares of our Series F 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 intoissued 107,846 unregistered shares of our common stock atto a conversion priceholder of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and collectively with theour Series E Convertible Preferred Stock the “Securities”) to purchase 0.75 shares of common stock for each share of common stock issuable uponin connection with the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share$53,923 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 July 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 $1.4 million from the sale of the Securities, after deducting placement agent fees and estimated expenses payable by us of approximately $180,000 associated with such closing. We intend to use the proceeds of the offering for funding our commercial operations to the sale and promotion“Stated Value” 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 308,000 shares of our common stock. The Warrant has a five-year term and an exercise price of $0.55 per share.

Stock Option Grants

In July 2018, we granted our Chief Executive Officer, Robert Moscato Jr. 1,500,000 Incentive Stock Options; Uli Hacksell, Ph. D., the Chairman of our Board, 1,000,000 Incentive Stock Options; and Erik Emerson, our Chief Commercial Officer, 1,125,000 Incentive Stock Options.Series E Convertible Preferred Stock.

 

 2321 

 

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

 

Forward-Looking Statements

 

This report containsQuarterly Report on Form 10-Q includes a number of forward-looking statements.statements within the meaning ofthe Private Securities Litigation Reform Act of 1995,Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that reflect management’s current views with respect to future events and financial performance. 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 April 17, 2018. Certain statements made in this discussion are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.16, 2019. 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 the 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 Quarterly Report on Form 10-Q 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 or 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
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, 2017,2018, as filed with the SEC on April 17, 2018,16, 2019, 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’sour or itsour 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.

24

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,Adhera Therapeutics, Inc., a Delaware corporation, and its wholly-owned subsidiaries, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc., Atossa Healthcare, Inc., and IthenaPharma, Inc. Unless otherwise specified, all dollar amounts are expressed in United States dollars. Our common stock is currently listed on the OTC Market, OTCQB tier, under the symbol “MRNA.“ATRX.

 

Corporate Overview

 

Nature of Business

 

We are a fully integrated, commercial stagean emerging specialty pharmaceutical company delivering proprietary drug therapeuticsthat leverages innovative distribution models and technologies to improve the quality of care for significant unmet medical needspatients in the U.S., EuropeUnited States suffering from chronic and certain additional international markets. Our portfolio of products currently focusesacute diseases. We are focused on fixed dose combinationscombination (“FDC”) therapies in hypertension, arthritis, pain and oncology allowing for innovative solutionswith plans to such unmet medical needs. expand the portfolio of drugs we commercialize to include other therapeutic areas.

Our mission is to provide effective and patient centric treatment for hypertension – includingand resistant hypertension. In this connection, we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certainhypertension while actively seeking additional assets that can be commercialized through our proprietary Total Care System (“TCS”). At the core of the intellectual property assets related to theour TCS is DyrctAxess, our patented technology platform known asplatform. DyrctAxess also called Total Care, that offersis designed to offer enhanced efficiency, control and access to the information necessary to empower patients, physicians and manufacturers to help achieve optimal care.

 

In doing so,We began marketing Prestalia®, a single-pill FDC of perindopril arginine (“perindopril”) and amlodipine besylate (“amlodipine”) in June of 2018. By combining Prestalia, DyrctAxess and an independent pharmacy network, we have created a universal platformproprietary system for drug adherence and the effective treatment of hypertension, as well as forimproving the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, andas well as improving the other products in our pipeline,distribution of devices for therapeutic drug monitoring (“TDM”) (e.g., blood pressure and other cardiac monitors,monitors), as well as services such aspatient counseling and prescription reminders.

reminder services. We currently have oneare focused on demonstrating the therapeutic and commercial and three clinical development programs underway: (i) Prestalia® (Prestalia),value of our TCS through the commercialization of Prestalia. Prestalia was developed in coordination with Les Laboratories Servier, a single-pill fixed dose combination of perindopril argenine (perindopril), an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine besylate (amlodipine), a calcium channel blocker (“CCB”), which has beenFrench pharmaceutical conglomerate, that sells the formulation outside the United States under the brand names Coveram® and/or Viacoram®. Prestalia was approved by the U.S. Food and Drug Administration (“FDA”) in January 2015 and is marketeddistributed through our DyrctAxess platform, which we acquired 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.2017.

 

DuringBy combining Prestalia, DyrectAxess, and a specialty pharma network, we have created a proprietary platform for drug adherence and the six months ended June 30, 2018, we received proceeds of approximately $12.3 million from the sale of our newly created Series E Convertible Preferred Stock (the “Series E Preferred Stock”), net of fees and expenses. The use of funds from the raise will be on the commercialization of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and other general corporate requirements. For the development of IT-102 and 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 theeffective treatment of hypertension.

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We intend to create value throughhypertension, improving the continued commercializationdistribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, while moving our FDC development programs forward to further strengthen our commercial presence. We intend to retain ownershipdevices for therapeutic drug monitoring (e.g., blood pressure and control of all of our product candidates, but in the interest of accelerated growthother cardiac monitors), as well as patient counseling 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.prescription reminder services.

 

As our strategy is to be a fully integratedcommercial pharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, with a secondary focus on advancingwhile continiuing to develop our FDC pipelinetechnology platform and TCS. We intend to further enhance our commercial presence.

Reverse Stock Split

In August 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 oncreate value through 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 this report give effect to the reverse split.

Reverse Merger with IThenaPharma

In November 2016, we 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 our 2017 Annual Report on Form 10K filed with the 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, in June 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, an ACE inhibitor, and amlodipine, 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 of 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 andexpanded commercialization of our two other hypertension pipeline products – namely IT-102FDA-approved product, Prestalia, while continuing to develop and IT-103, as well as any other similar products that we internally develop or acquire.leverage our TCS to further strengthen our commercial presence.

 

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Line Letters with Related Parties

In connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Vuong Trieu, Ph.D., a current director of the Company and former 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 had advanced the full $540,000 under the Line Letter as of December 31, 2017. In April 2018, and in connection with the closing of our private placement of our Series E Preferred Stock, we issued to Dr. Trieu 114.63 shares of Series E 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. The securities that were issued to Dr. Trieu have the same terms and conditions as the Securities that were issued to investors in the Series E Preferred Stock offering. As a result of the conversion of the line of credit, all of our obligations to Dr. Trieu thereunder have been satisfied and the line of credit is no longer outstanding.

In April 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 our common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board. In April 2018, and in connection with the closing of our private placement of our Series E Preferred Stock, we issued to Autotelic Inc. 19 shares of Series E 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. The securities that were issued to Autotelic Inc. have the same terms and conditions as the Securities that were issued to investors in the Series E Preferred Stock offering. 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.

Agreement with Autotelic BIO

On January 11, 2018, we entered into a 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 “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, a current director of the Company and former 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 DiLA2 delivery 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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Recent Developments During the Three Months Ended June 30, 2018March 31, 2019

  

Series E Convertible Preferred Stock Private PlacementCo-Promotion Agreement

 

We created a new class of Preferred Stock, namely the Series E Convertible Preferred Stock (Series E Preferred Stock), to raise funds through a 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 Preferred Stock at a purchase price of $5,000 per share of Series E Preferred Stock. On May 17, 2018, we conducted the second and final closing (the “Final Closing”) of the private placement of the Series E Preferred Stock. In total, we received aggregate gross proceeds of approximately $14.1 million from the private placement of Series E Preferred Stock, prior to deducting placement agent fees and estimated expenses. Also, we issued 678 shares of our Series E Preferred Stock to satisfy certain of our debt and payable obligations and converted such liabilities. In connection with the Final Closing, we entered into subscription agreements with certain accredited investors pursuant to which we sold 478 shares of Series E Preferred Stock at a purchase price of $5,000 per share. 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 Series E 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 Series E Preferred Stock purchased by such investor at an exercise price equal to $0.55 per share of common stock, subject to adjustment thereunder.

We intend to use the proceeds from the private placement for funding operations, working capital needs, capital expenditures, the repayment of certain liabilities and other general corporate purposes in pursuit of advancing our commercial, clinical and preclinical efforts, including advancing our commercial operations relating to the sale and promotion of the Company’s Prestalia® product.

The Series E 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 Series E 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. Maxim Merchant Capital, a division of Maxim Group LLC, acted as placement agent in connection with the private placement of Series E Preferred Stock.

Stipulation of Settlement

In April 2018,March 4, 2019, we entered into a Stipulationco-promotion agreement with Alyvant, Inc. The agreement affords us with the opportunity to increase the frequency of Settlement requiring uscommunication to issue Vaya Pharma shareshealthcare providers and educate physicians beyond the reach of our common stock with a fair value of $250,000, which shares were issued during the second fiscal quarter of 2018.sales team.

 

Resignation and Appointment of Officer and Directors

 

Eric Teague, our Chief Financial Officer, and Erik Emerson, our Chief Commerical Officer, resigned from such positions, during the three months ended March 31, 2019. On April 27, 2018, our Board of Directors (the “Board”) increased the size of the entire Board from five (5) directors to seven (7) directors, and it4, 2019, we appointed each of Erik Emerson and Tim Boris to fill the vacancies created thereby.

In May 2018, each of Philip C. Ranker and Philippe P. Calais, Ph.D. resignedNancy Phelan 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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In May 2018, the Board accepted the resignation of Joseph W. Ramelli, our former 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 received a salary in the amount of $20,000 per month. Dr. Trieu resigned from his position as Interim Chief Executive Officer on June 18, 2018.

On June 18, 2018, the Board appointed Robert C. Moscato, Jr., to serve as our Chief Executive Officer of the Company, effective immediately.Officer. In connection with the appointment of Mr.Ms. Phelan, Robert J. Moscato, as Chief Executive Officer, Dr. TrieuJr., a director and officer, resigned as Interim Chief Executive Officer, and also from his positionpositions as Executive Chairman of our company, effective immediately.

On June 18, 2018, the Board appointed Uli Hacksell, Ph.D. to serveCEO, Secretary, and as a member of the Board, with Dr. Hacksell also being appointed to serve as Chairman of the Board, effective July 1, 2018. Dr. Hacksell agreed to devote half of his business time to Marina.

On June 28, 2018, the Board appointed Mr. Moscato to serve as a member of the Board, effective July 1, 2018.

Issuance of Preferred Stock and Warrants to Directors

In April 2018, anddirector. These management changes are more fully described in connection with the closing of our private placement of our Series E Preferred Stock, 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 have the same terms and conditions as the Securities that were issued to investors in the Series E Preferred Stock offering.

Issuance of Securities to June 2016 Noteholders

In April 2018, and in connection with the closing of our private placement of our Series E Preferred Stock, 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.5 – Related Party Transaction herein.

In July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to the 2016 Notes and the warrants to purchase shares of our common stock that are currently held by the June 2016 Noteholders 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, Cequent 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 2016 Notes to December 31, 2017, to provide for the 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 June 2016 Noteholders with respect to dilutive offerings afforded thereunder to February 10, 2020. In addition, in April 2018, and in connection with the closing of our private placement of our Series E Preferred Stock, we issued to the June 2016 Noteholders an aggregate of 75 shares of Series E 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 June 2016 Noteholders pursuant to that certain amendment agreement dated July 3, 2017 by and among our company and the June 2016 Noteholders.

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Issuance of Securities to June 2017 Noteholders

In April 2018, and in connection with the closing of our private placement of our Series E Preferred Stock, 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 505,705 shares of common stock (of which 9.27 shares were subsequently cancelled and also paid cash to certain of the June 2017 Noteholders cash in the amount of $46 thousand) 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 2017 Notes and the issuance of the Securities to the June 2016 Noteholders (and payment of cash), the entire unpaid principal balance of the 2017 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 Series E Preferred Stock offering.

Issuance of Securities to Blech Trust

In April 2018, and in connection with the closing of our private placement of our Series E Preferred Stock, 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 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 1,219,425 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount of approximately $812,950, and other liabilities, owed to Autotelic Inc. as of March 31, 2018 pursuant to the MSA. 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 (See Note 5). Such warrants have a five-year term, an exercise price of $0.55. In addition, we issued 1,345,040 warrants to purchase shares of common stock to Autotelic to satisfy a liability to issue warrants as of March 31, 2018. Such warrants have a five-year term, an exercise price of $0.55, and have a fair value of $1,494,469 resulting in a loss on settlement of debt of $754,697.

Stock Issuance to Novosom

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.

Reclassification of Prior Period Presentation

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

30

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2018March 31, 2019 to the Three Months Ended June 30, 2017March 31, 2018

 

RevenuesNet Sales

 

Net sales were $2,881 for the three months ended March 31, 2019, and represents revenues from the sale of Prestalia, net of discounts. We had no revenuessales during the three months ended June 30, 2018 or 2017, respectively. We have not recognized revenue of approximately $58,000 of shipments of Prestalia during the three months ended June 30, 2018 until such time the Company determines that collection is probable. As the Company has yet to complete certain performance obligations under a licensing agreement for the sale of our DiLA2 assets, we have deferred the recognition of revenue of $200,000 until such obligations are fulfilled.March 31, 2018. 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.

 

Cost of Sales

Cost of sales were $116,933 for the three months ended March 31, 2019, and represents cost of sales from the sale of Prestalia. We had no sales or cost of sales during the three months ended March 31, 2018.

Operating Expenses

 

Our operating expenses for the three months ended June 30, 2018March 31, 2019 are summarized as follows in comparison to our expenses for the three months ended June 30, 2017.March 31, 2018.

 

 Three Months Ended 
 June 30, June 30,  Three Months Ended 
 2018 2017  March 31, 2019  March 31, 2018 
          
Sales, marketing and commercial operations $2,585,945  $-  $1,059,222  $- 
Research and development  -   439,894   -   173,256 
General and administrative expenses  1,059,088   402,794   1,367,303   919,908 
Amortization  123,262   106,226   17,575   123,261 
Other expense  879,853   222,279 
Loss before provision for income taxes $4,648,148  $1,171,193 
Total operating expenses $2,444,100  $1,216,425 

 

Sales, Marketing and Commercial Operations

 

Sales,For the three months ended March 31, 2019, sales, marketing and commercial operations expense increased by approximately $2.6$1.1 million, as compared to the prior period, primarily due to the activities related to the launch and ongoing of Prestaliasales of approximately $1.5 million, product costsand related activities of approximately $0.4 million, personnel cost of approximately $0.2 million, regulatory affairs expenses of approximately $0.1 million and other related costs of approximately $0.4 million.Prestalia.

 

Research and Development

 

ResearchFor the three months ended March 31, 2019, research and development (“R&D”) expense decreased by approximately $0.4$0.2 million, as compared to the three months ended June 30, 2017March 31, 2018 due to the Company’stransition of our primary focus transitioning from research and developmentR&D activities to sales, marketing and commercial operations activities effective April 2018.

General and Administrative

General and administrative (“G&A”) expense increased by approximately $0.7 million for the three months ended June 30, 2018, as compared to the three months ended June 30, 2017, primarily due an increase in stock option expense of approximately $0.4 million, an increase of approximately $0.1 million in payroll expense, an increase of approximately $0.1 million in legal fees and other costs of approximately $0.1 million.

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Amortization Expense

Amortization expenses relate to amortization of intangible assets acquiredbeginning in the November 15, 2016 merger and the asset purchases on June 5, 2017 and July 21, 2017, with an aggregate estimated fair valuesecond quarter of $3.1 million.

Other Expense

  Three Months Ended 
  June 30,  June 30, 
   2018   2017 
Interest expense $5,156  $15,621 
Change in fair value liability of warrants  -   10,715 
Loss on settlements  874,697   - 
Change in fair value of derivative liability  -   195,943 
Total other expense, net $879,853  $222,279 

Total net other expense for the three months ended June 30, 2018 increased approximately $0.7 million compared to the three months ended June 30, 2017. The increase is attributable to a non-cash loss on settlement of debt incurred of approximately $0.9 million during the three months ended June 30, 2018, primarily due to a loss of $0.8 million related to warrants issued Autotelic, Inc. to satisfy outstanding liabilities where the fair value of the warrants exceeded the value of liabilities settled as part of the Series E Preferred Stock private placement and partially offset by approximately $0.2 million due to change in the fair value of the derivative on the line of credit. There was no gain or loss on the change in fair value liability of warrants during the three months ended June 30, 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 the modified retrospective approach.

Comparison of the Six Months Ended June 30, 2018 to the Six Months Ended June 30, 2017

Revenues

We had no revenues during the six months ended June 30, 2018 or 2017, respectively. We have not recognized revenue of approximately $58,000 of shipments of Prestalia during the six months ended June 30, 2018 until such time the Company determines that collection is probable. As the Company has yet to complete certain performance obligations under a licensing agreement for the sale of our DiLA2 assets, we have deferred the recognition of revenue of $200,000 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 six months ended June 30, 2018 are summarized as follows in comparison to our expenses for the six months ended June 30, 2017.

  Six Months Ended 
  June 30,  June 30, 
  2018  2017 
       
Sales, marketing and commercial operations $2,585,945  $- 
Research and development  173,256   513,325 
General and administrative expenses  1,978,996   1,198,238 
Amortization  246,523   204,604 
Other expense  1,024,597   337,004 
Loss before provision for income taxes $6,009,317  $2,253,171 

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Sales, marketing and commercial operations

Sales, marketing and commercial operations expense increased by approximately $2.6 million due to launch activities related to the launch of Prestalia of approximately $1.5 million, manufacturing and related activities of approximately $0.4 million, personnel cost of approximately $0.2 million, regulatory affairs expenses of approximately $0.1 million and other related costs of approximately $0.4 million.

Research and Development

Research and development (“R&D”) expense decreased by approximately $0.3 million, as compared to the six months ended June 30, 2017 due to the Company’s primary focus transitioning from research and development activities to sales, marketing and commercial operations activities effective April 2018.

General and Administrative

 

General and administrative (“G&A”) expense increased by approximately $0.8$0.4 million for the sixthree months ended June 30, 2108,March 31, 2019, as compared to the sixthree months ended June 30, 2017,March 31, 2018, primarily due to a charge of approximately $0.4 million related to the settlement of our 2016 notes, an increase in stock option expenseshare based compensation of approximately $0.4 million, an increase in payroll expense of $0.2 million and increase in other costs of $0.1$0.3 million. These increases were partially offset by a decrease of approximately $0.2 million in legal fees and approximately $0.1 million in other costs.

 

Amortization Expense

 

Amortization expenses relate to amortization of intangible assets acquired in the November 15, 2016 merger and the asset purchases on June 5, 2017 and July 21, 2017, with an aggregate estimated fair value of approximately $3.1 million.$0.7 million (reduced by the impairment loss of $0.2 million due to the finalization of the purchase price allocation during the year ended December 31, 2018).

 

Other Expense

 

  Six Months Ended 
  June 30,  June 30, 
  2018  2017 
Interest expense $149,900  $27,274 
Change in fair value liability of warrants  -   113,787 
Loss on settlement  874,697   - 
Change in fair value of derivative liability  -   195,943 
Total other expense, net $1,024,597  $337,004 
  Three Months Ended 
  March 31, 2019  March 31, 2018 
Interest expense $      -  $(144,744)
Total other expense, net $-  $(144,744)

 

Total net other expense for the sixthree months ended June 30, 2018 increased approximately $0.7March 31, 2019 decreased $0.1 million compared to the sixthree months ended June 30, 2017. The increase is primarily attributable to the loss on settlement of debt incurred of approximately $0.9 million during the six months ended June 30, 2018, primarily due to a non-cash loss of approximately $0.8 million related to warrants issued Autotelic, Inc. to satisfy outstanding liabilities where the fair value of the warrants exceeded the value of liabilities settled as part of the Series E Preferred Stock private placement. Additionally, there was an increase in interest expense of approximately $0.1 million from new notes and lines of credit taken in 2017. Such debt and accrued interest thereon was settled as part of the Series E Preferred Stock private placement. The increases were partially offset by approximately $0.2 million due to change in the fair value of the derivative on the line of credit and approximately $0.1 million due to change in fair value of warrants. There was no gain or loss on the change in fair value liability of warrants during the six months ended June 30,March 31, 2018 due to the adoptionelimination of Accounting Standards Update 2017-11 in November 2017 relating to the issuance of financial statements that include down round provisions utilizing the modified retrospective approach.notes payable during 2018.

33

 

Liquidity & Capital Resources

 

Working Capital

 

  June 30,  December 31, 
  2018  2017 
Current assets $8,645,582  $124,943 
Current liabilities  (2,337,466)  (5,735,503)
Working capital (deficiency) $6,308,116  $(5,610,560)

  March 31, 2019  December 31, 2018 
Current assets $2,617,048  $4,677,179 
Current liabilities  (2,760,236)  (2,214,126)
Working capital (deficit) $(143,188) $2,463,053 

 

Working capital as of June 30, 2018March 31, 2019 was approximately $6.3negative $0.1 million as to compared to negative working capital of approximately $5.6$2.5 million as of December 31, 2017.2018. As of June 30, 2018,March 31, 2019, current assets were approximately $8.6 million, primarily attributable to an increase in cash of approximately $8.4 million and prepaid expenses of approximately $0.2 million. As of December 31, 2017, current assets were approximately $0.1$2.6 million, primarily attributable to cash of approximately $0.1$1.8 million. The change inAs of December 31, 2018, current assets mainlywere approximately $4.7 million primarily attributable to cash was primarily a result of the Series E Convertible Preferred share private placement offering in April and May of 2018 in which we received net proceeds of approximately $12 million, offset by the cash spent to sustain operations.$3.9 million.

 

As of June 30, 2018,March 31, 2019, current liabilities were approximately $2.3 million. This was primarily on account$2.8 million, comprised of accounts payable of approximately $1.2$0.3 million, due to related party of approximately $0.1 million, accrued expenses of approximately $0.9 million, approximately $0.1 million of current portion of operating lease liability, and deferred revenueaccrued dividends of $0.2approximately $1.4 million. Comparatively, Asas of December 31, 2017,2018, current liabilities were $5.7$2.2 million, primarily consisting of approximately $2.4$0.3 million of accounts payable, accrued expenses of approximately $1.5$0.9 million and notes payableaccrued dividends of approximately $1.9$1.0 million. Current liabilities decreasedincreased by approximately $3.4$0.6 million, which was primarily attributable to an increase in accrued dividends and the settlementcurrent portion of notes payable and other liabilities of approximately $3.4 million by converting such debt and liabilities into the initial round of financing under the Series E Convertible Preferred Stock private placement in April of 2018 and paying accrued fees payable of approximately $0.3 million, partially offset by $0.2 million of deferring revenue recognition on the sale of our DiLA2 assets and change in accounts payable of approximately $0.1 million.operating lease liability.

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Cash Flows and Liquidity

  Six Months Ended 
  June 30,  June 30, 
  2018  2017 
       
Net cash used in operating activities $(3,856,143) $(732,487)
Net cash used in investing activities  (10,504)  (300,000)
Net cash provided by financing activities  12,114,391   1,191,053 
Increase in cash $8,247,744  $158,566 

 

Net cash used in Operating Activities

 

Net cash used in operating activities was approximately $3.9$2.1 million during the sixthree months ended June 30, 2018.March 31, 2019. This was primarily due to theour net loss of approximately $6.0$2.6 million, and changes in working capital of $0.2 million,partially offset by non-cash charges of approximately $2.1 million and deferred revenue of $0.2 million. Non-cash charges comprised of approximately $0.5 million of share based compensation $0.3 million of non-cash settlement of litigation and license fees, depreciation and amortization of intangibles and debt discount of approximately $0.4 million and non-cash settlement of liabilities of approximately $0.9 million.

 

Comparatively, net cash used in operating activities was approximately $0.7 million$59,000 during the sixthree months ended June 30, 2017.March 31, 2018. This was primarily due to the net loss of approximately $2.3$1.4 million offset by non-cash charges of approximately $0.7$0.6 million and change in working capital of approximately $0.9$0.7 million. Non-cashThe non-cash charges were comprised of approximately $0.1 million of share based compensation, $0.1 million of services paid in company stock, amortization of intangibles, $0.1 million of non-cash interest expense and deferred revenue of approximately $0.2 million and fair value of warrants liability and derivatives of approximately $0.3 million.

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Net cash used in Investing Activities

 

NetThere was no cash used in or provided by investing activities duringfor the sixthree months ended June 30, 2018 was to purchase of furniture approximately $10 thousand as compared to $0.3 million to purchase intangible assets during the six months ended June 30, 2017.March 31, 2019 or 2018.

 

Net cash provided by Financing Activities

 

NetThere was no cash used in or provided by financing activities of approximately $12.1 million duringfor the sixthree months ended June 30, 2018 was primarily due to the approximately $12.3 million received from the sale of our Series E Preferred Stock, net of fees and offset by approximately $0.1 million for repayment of a debt. Correspondingly, during the six months ended June 30, 2017, net cash provided by financing activities was approximately $1.2 million. This was primarily attributable to proceeds of approximately $0.25 million from the sale of common stock, approximately $0.8 million borrowings on third party and related party notes payable, and approximately $0.2 million from the exercise of common stock warrants.March 31, 2019 or 2018.

 

We maywill need to raise additional operating capital in calendar year 2018during the second quarter of 2019 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 maywill not have the cash resources to continue as a going concern thereafter.

 

Future Financing

 

We will require immediate substantial 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 substantial 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 willare 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, modify or perhaps even cease our operations.

 

Off-Balance Sheet Arrangements

 

As of June 30, 2018,March 31, 2019, 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 June 30, 2018March 31, 2019 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017.2018.

 

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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 June 30, 2018.March 31, 2019.

 

ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

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ITEM 4 CONTROLS AND PROCEDURES

 

Evaluation of 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,We maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the supervisionSecurities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and withreported within the participation oftime periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our senior management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives.

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e)as of the end of the period covered by this report. Based upon that evaluation and 15d-15(e) undersubject to 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, 2017 (the “2017 Form 10-K”), which have not been fully remediated, and thereforeforegoing, our principal executive officer and our principal financial officer concluded that, as of June 30, 2018, our disclosure controls and procedures were not effective due to the material weakness(es) in internal control over financial reporting described below.

Material Weakness in Internal Control over Financial Reporting

Management conducted an assessment of the effectiveness of our internal control over financial reporting as of March 31, 2019 based on the framework established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management has determined that our internal control over financial reporting as of March 31, 2019 was not effective.

 

A material weakness, as defined in the standards established by the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

The ineffectiveness of our internal control over financial reporting was due to the following material weaknesses which are indicative of many small companies with small number of staff:

Inadequate segregation of duties consistent with control objectives;
Lack of qualified accounting personnel to prepare and report financial information in accordance with GAAP; and
Lack of documentation on policies and procedures that are critical to the accomplishment of financial reporting objectives.

27

Internal Control Over Financial ReportingManagement’s Plan to Remediate the Material Weakness

 

Management has reportedbeen implementing and continues to implement measures designed to ensure that control deficiencies contributing to the Boardmaterial weakness are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions planned include:

Identify gaps in our skills base and the expertise of our staff required to meet the financial reporting requirements of a public company; and
Continue to develop policies and procedures on internal control over financial reporting and monitor the effectiveness of operations on existing controls and procedures.

During the three months ended March 31, 2019, we continued to execute upon our planned remediation actions which are all intended to strengthen our overall control environment. Our Company and all subsidiaries use a well-regarded accounting software which restricts personnel access and standardizes daily accounting procedures on journal entries. The software includes built-in controls and documentation to facilitate accounting review of Directorsthe books and therecords. Our Audit Committee thereof material weaknesses described under the heading “Management Report on Internal Control” contained in Item 9A of the 2017 Form 10-K. The material weaknesses discussed thereincontinues to exercise oversight responsibilities related to financial reporting and internal control, and we have not been fully remediated. In connection with such remediation efforts, in October 2017 we engaged Amit Shahcommenced a search to serve asreplace our Chief Financial Officer. Officer, who recently resigned. In the meantime, the Company’s Chief Executive Officer will assume the responsibilities of the Chief Financial Officer until we hire a full-time executive. We have hired an external consultant with GAAP expertise to assist in the preparation of financial reporting under management oversight.

The aforementioned measures taken are expected to lead to an improvement in the timely preparation of financial reports and to strengthen our segregation of duties at the Company. We are committed to maintaining a strong internal control environment, and we believe that these remediation efforts will represent significant improvements in our control environment. Our management will continue to monitor and evaluate the relevance of our risk-based approach and the effectiveness of our internal controls and procedures over financial reporting on an ongoing basis and is committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds allow.

Changes in Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting or(as defined in other factorsRule 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter ended June 30, 2018March 31, 2019 that have materially affected, or that 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, 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.

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

 

We had been named in a complaint filed in the Supreme Court of the State of New York as a defendant in the matter entitled Vaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. Although the complaint had been filed, we had not been legally served. The complaint 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) we were liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement we 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. In 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.Paragraph IV Challenge

 

36

Our Prestalia product is currentlywas involved in a paragraph IV challenge regarding patents issued to perindopril arginine. This challenge, which is currentlywas pending in the United States District Court for the District of Delaware (No. 1:17-cv-00276), iswas captionedApotex Inc. and Apotex Corp. v. Symplmed Pharmaceuticals, LLC and Les Laboratories Servier.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 seekssought a declaratory judgment that no valid claims of the two 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 iswas designed to provide Apotex with an opportunity to enter the market with a generic version of Prestalia, ahead of the expiration 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 challenge in the second quarter of 2017, and such2017. Such parties, along with us, have come to a generalreached an agreement on terms that will result in a delay to the challengers’ ability to enter the market with a generic version of Prestalia, while still providing the challenger with the right to enter the market prior to the expiration of the patent covering such product. The term sheet memorializing such terms is pending executionSpecifically, the parties have entered into a Confidential Settlement Agreement in a finalconnection with the 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 matter, pursuant to which, among other things, the parties entered into a Confidential License Agreement, whereby Symplmed, Servier and our company agreed to grant to Apotex a non-transferable, non-sublicensable, perpetual, irrevocable, royalty-free, non-exclusive license to the two patents listed in the FDA Orange Book as having claims covering Prestalia to make, use and market a generic version of Prestalia, or import a generic version of Prestalia from India into the United States, on or after January 1, 2021.

As a result of the foregoing, the matter is now settled.

General

Currently, there is no material litigation continuespending against our company other than as disclosed above. From time to time, we may become a party to litigation and subject to claims incident to the ordinary course of our business. Although the results of such litigation and claims in the ordinary course of business cannot be predicted with alignment from all parties, including Servier, Apotex, Symplmedcertainty, we believe that the final outcome of such matters will not have a material adverse effect on our business, results of operations or financial condition. Regardless of outcome, litigation can have an adverse impact on us because of defense costs, diversion of management resources and Marina. Necessary extensions have been agreed upon and final resolution is anticipated this year.other factors.

 

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, 20172018 (the “Annual Report”), as filed with the SEC on April 17, 2018,16, 2019, in addition to other information contained in those documents and reports that we have filed with the Securities and Exchange commissionSEC 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 April 2018, we entered into a Stipulation 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 Vaya Pharma shares of our common stock with a fair value of $250,000 (a total of 210,084 shares), which shares were issued in May 2018. 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.

In May 2018,2019, 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 June 30, 2018, we issued 433,334107,846 unregistered shares of our common stock to the holdersa holder of our Series CE Convertible Preferred Stock in connection with the conversion of 650 shares$53,923 of “Stated Value” of our Series CE Convertible Preferred Stock. These securitiesshares 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.

During the fiscal quarter ended June 30, 2018, we issued 25,000 unregistered shares of our common stock to the holders of our Series D Convertible Preferred Stock in connection with the conversion of 20 shares of our Series D 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
3.1Certificate of Designation of Preferences, Rights and Limitations of the Series E Convertible Preferred Stock of Marina Biotech, Inc. (filed as Exhibit 3.1 to our Current Report on Form 8-K dated April 16, 2018, and incorporated herein by reference).
3.2Certificate of Designation of Preferences, Rights and Limitations of the Series F Convertible Preferred Stock of Marina Biotech, Inc. (filed as Exhibit 3.1 to our Current Report on Form 8-K dated July 11, 2018, and incorporated herein by reference).
4.1Form of Common Stock Purchase Warrant issued in connection with the offering of the Series E Convertible Preferred Stock of Marina Biotech, Inc. (filed as Exhibit 4.1 to our Current Report on Form 8-K dated April 19, 2018, and incorporated herein by reference).
4.2Form of Common Stock Purchase Warrant issued in connection with the offering of the Series F Convertible Preferred Stock of Marina Biotech, Inc. (filed as Exhibit 4.1 to our Current Report on Form 8-K dated July 11, 2018, and incorporated herein by reference).
10.1Placement Agency Agreement, dated February 8, 2018, by and between Marina Biotech, Inc. and Maxim Merchant Capital, a division of Maxim Group LLC (filed as Exhibit 10.1 to our Current Report on Form 8-K dated May 17, 2018, and incorporated herein by reference).
10.2Form of Subscription Agreement used in connection with the offering of the Series E Convertible Preferred Stock of Marina Biotech, Inc. (filed as Exhibit 10.2 to our Current Report on Form 8-K dated May 17, 2018, and incorporated herein by reference).
10.3Employment Agreement, dated June 18, 2018, by and between Marina Biotech, Inc. and Robert C. Moscato, Jr. (filed as Exhibit 10.1 to our Current Report on Form 8-K dated June 18, 2018, and incorporated herein by reference).
   
31.1 Certification of our Principal Executive Officer pursuant to Rule 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
31.2Certification of our Principal Financial Officer pursuant to Rule 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (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)
32.2Certification of ourand 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)
   
101INS XBRL Instance Document (1)
   
101SCH XBRL Taxonomy Extension Schema Document (1)
   
101CAL XBRL Taxonomy Extension Calculation Linkbase Document (1)
   
101DEF XBRL Taxonomy Extension Definition Linkbase Document (1)
   
101LAB XBRL Taxonomy Extension Label Linkbase Document (1)
   
101PRE XBRL Taxonomy Extension Presentation Linkbase Document (1)
   

(1)

 Filed herewith.
(2) Furnished herewith.

38

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,ADHERA THERAPEUTICS, INC.
  
Date: August 10, 2018May 15, 2019By:/s/ Robert C. Moscato Jr.Nancy R. Phelan.
  Robert C. Moscato Jr.Nancy R. Phelan
  Chief Executive Officer and Director
  (Principal Executive Officer)
Date: August 10, 2018/s/ Amit Shah
Amit Shah
Chief Financial Officer,
(Principal Financial Officer and Principal Accounting Officer)

39