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EX-31.1 - EXHIBIT 31.1 - Adhera Therapeutics, Inc.t1401585_ex31-1.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarter Ended June 30, 2014

 

Commission File Number 000-13789

 

 

MARINA BIOTECH, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 11-2658569
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
   
P.O. Box 1559, Bothell, WA 98041
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (425) 892-4322

 

 

  

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 þ 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 þ No ¨

 

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

 

Large accelerated filer ¨ Accelerated filer ¨
       
Non-accelerated filer ¨ (Do not check if a smaller reporting company) Smaller reporting company þ

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No þ

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

 

Date     Class     Shares Outstanding  
                     
  August 7, 2014       Common stock — $0.006 par value       25,633,061  

 

 

 
 

  

MARINA BIOTECH, INC. AND SUBSIDIARIES

TABLE OF CONTENTS

 

PART I — FINANCIAL INFORMATION  
   
ITEM 1 — FINANCIAL STATEMENTS (unaudited)  
Condensed Consolidated Balance Sheets as of December 31, 2013 and June 30, 2014 3
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2013 and  2014 4
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2013 and  2014 5
Notes to Condensed Consolidated Financial Statements 6
ITEM 2 — MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 13
ITEM 3 — QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 16
ITEM 4 — CONTROLS AND PROCEDURES 16
   
PART II — OTHER INFORMATION  
ITEM 2 — UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 17
ITEM 6 — EXHIBITS 17
SIGNATURES 18
EXHIBIT INDEX 19

 

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

 

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PART I — FINANCIAL INFORMATION

 

ITEM 1 — FINANCIAL STATEMENTS

  

MARINA BIOTECH, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   December 31,   June 30, 
(In thousands, except share data)  2013   2014 
ASSETS          
Current assets:          
Cash  $909   $4,317 
Accounts receivable   5    - 
Prepaid expenses and other current assets   128    85 
Total current assets   1,042    4,402 
Intangible assets   6,700    6,700 
Total assets  $7,742   $11,102 
LIABILITIES AND STOCKHOLDERS’ DEFICIT          
Current liabilities:          
Accounts payable  $1,614   $1,053 
Accrued payroll and employee benefits   1,505    17 
Accrued interest   147    - 
Other accrued liabilities   1,315    951 
Accrued restructuring   12    - 
Notes payable   1,615    - 
Other debt   8    3 
Total current liabilities   6,216    2,024 
Fair value liability for price adjustable warrants   5,226    10,061 
Fair value of stock to be issued to settle liabilities   1,019    - 
Deferred tax liabilities   2,345    2,345 
Total liabilities   14,806    14,430 
Commitments and contingencies          
Stockholders’ deficit:          
Series C convertible preferred stock, $.01 par value; none and 1,200 shares authorized, issued and outstanding at December 31, 2013 and June 30, 2014, respectively (preference in liquidation of $6,000 at June 30, 2014)   -    - 
Common stock, $0.006 par value; 180,000,000 shares authorized, 16,937,661 and 25,633,061 shares issued and outstanding at December 31, 2013 and June 30, 2014, respectively   102    155 
Additional paid-in capital   324,145    332,985 
Accumulated deficit   (331,311)   (336,468)
Total stockholders’ deficit   (7,064)   (3,328)
Total liabilities and stockholders’ deficit  $7,742   $11,102 

 

See accompanying notes to the condensed consolidated financial statements.

  

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MARINA BIOTECH, INC. AND SUBSIDIARIES

  

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended June 30,   Six Months Ended June 30, 
(In thousands, except per share data)  2013   2014   2013   2014 
License and other revenue  $315   $-   $315   $- 
Operating expenses:                    
Research and development   99    49    215    95 
General and administrative   402    622    612    1,139 
Total operating expenses   501    671    827    1,234 
Loss from operations   (186)   (671)   (512)   (1,234)
Other income (expense):                    
Change in fair value liability for price adjustable warrants   (61)   4,545    1,981    (769)
Gain on settlement of liabilities   -    45    -    302 
Gain on foreign exchange   -    2    -    2 
Gain (loss) on debt extinguishment   -    -    (930)   4 
Gain on sale of equipment   30    -    30    - 
Change in fair value of embedded features in notes and amendments to notes   315    -    587    - 
Interest and other expense   (63)   -    (122)   (1,007)
Change in fair value of stock reserved for issuance to settle liabilities   (42)   -    335    (2,455)
Total other income (expense), net   179    4,592    1,881    (3,923)
Net income (loss)   (7)   3,921    1,369    (5,157)
Deemed dividend related to beneficial conversion feature in Series C convertible preferred shares   -    -    -    (6,000)
Net income (loss) applicable to common stockholders  $(7)  $3,921   $1,369   $(11,157)
                     
Net income (loss) per common share                    
Basic  $(0.00)  $0.15   $0.08   $(0.47)
Diluted  $(0.00)  $0.11   $0.06   $(0.47)
                     
Shares used in computing net income (loss) per share                    
Basic   16,938    25,633    16,938    23,563 
Diluted   16,938    34,801    22,985    23,563 

 

See accompanying notes to the condensed consolidated financial statements.

 

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MARINA BIOTECH, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Six Months Ended June 30, 
(In thousands)  2013   2014 
Operating activities:          
Net income (loss)  $1,369   $(5,157)
Adjustments to reconcile net loss to net cash used in operating activities:          
Non-cash (gain)/loss on debt extinguishment   930    (4)
Non-cash interest expense   122    1,007 
Non-cash gain on settlement of liabilities   -    (302)
Compensation related to stock options, restricted stock and employee stock purchase plan   57    107 
Gain on foreign exchange transactions   -    (2)
Gain on disposition of property and equipment   (30)   - 
Changes in fair market value of liabilities          
Stock reserved for issuance to settle liabilities   (335)   2,455 
Price adjustable warrants   (1,981)   769 
Debt features   (587)   - 
Changes in assets and liabilities          
Accrued restructuring   (380)   (12)
Prepaid expenses and other assets   94    43 
Accounts payable   (26)   (561)
Accrued and other liabilities   357    (614)
Accounts receivable   2    5 
Net cash used in operating activities   (408)   (2,266)
           
Investing activities:          
Change in restricted cash   380    - 
Proceeds from the sale of property and equipment   30    - 
Net cash provided by investing activities   410    - 
           
Financing activities:          
Proceeds from sales of Series C preferred shares and warrants, net   -    5,929 
Cash payments of notes payable   -    (250)
Insurance financing   (6)   (5)
Net cash provided (used) by financing activities   (6)   5,674 
Net increase (decrease) in cash   (4)   3,408 
Cash and cash equivalents — Beginning of period   216    909 
Cash and cash equivalents — End of period  $212   $4,317 
Supplemental disclosure of cash flow information and non-cash financing activities:          
Cash paid for interest  $-   $83 
Reclassification of fair value liability for price adjustable warrants exercised  $-   $1,862 
Issuance of common stock to settle liabilities  $-   $3,474 
Debt conversion to common shares  $-   $1,479 
Deemed dividend to Series C convertible preferred stockholders  $-   $6,000 

 

See accompanying notes to the condensed consolidated financial statements.

 

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MARINA BIOTECH, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For the three and six months ended June 30, 2013 and 2014 (Unaudited)

 

Note 1 — Business, Liquidity and Summary of Significant Accounting Policies

 

Business

 

Marina Biotech, Inc. (collectively “Marina”, “the company”, “us” or “we”), in conjunction with our wholly-owned and financially consolidated subsidiaries, Cequent Pharmaceuticals, Inc. (“Cequent”), MDRNA Research, Inc. (“MDRNA”), and Atossa Healthcare, Inc. (“Atossa”), is a biotechnology company focused on the discovery, development and commercialization of nucleic acid-based therapies to treat orphan diseases. Since 2010, we have strategically acquired/in-licensed and further developed nucleic acid chemistry and delivery-related technologies to form an integrated drug discovery platform. We distinguish ourselves from others in the nucleic acid therapeutics area through this unique platform that enables the development of a variety of therapeutics targeting coding and non-coding RNA via multiple mechanisms of action such as RNA interference (“RNAi”), messenger RNA (“mRNA”) translational inhibition, exon skipping, miRNA (“miRNA”) replacement, miRNA inhibition, and steric blocking in order to modulate gene expression either up or down depending on the specific mechanism of action. Our goal is to dramatically improve the lives of the patients and families affected by orphan diseases through either our own efforts or those of our collaborators and licensees.

 

We are focusing our efforts and resources on the discovery and development of our own pipeline of nucleic acid-based compounds in order to commercialize drug therapies to treat orphan diseases. In addition, we will seek to establish collaborations and strategic partnerships with pharmaceutical and biotechnology companies to generate revenue through up-front, milestone and royalty payments related to our technology and/or the products that are developed using such technology.

 

Liquidity

 

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 June 30, 2014, we had an accumulated deficit of $336 million. To the extent that sufficient funding is available, we will in the future continue to incur losses as we continue our research and development (“R&D”) activities. In addition, we have had and will continue to have negative cash flows from operations. We have funded our losses primarily through the sale of common and preferred stock and warrants, revenue provided from our license agreements with other parties, and, to a lesser extent, equipment financing facilities and secured loans. At June 30, 2014, we had a working capital surplus of $2.4 million, which included $4.3 million in cash.

 

On February 24, 2014, certain debt holders exchanged secured promissory notes in the aggregate principal and interest amount of $1.5 million for 2.0 million shares of our common stock. In addition, on March 7, 2014, we entered into a Securities Purchase Agreement with certain investors pursuant to which we sold 1,200 shares of our Series C Convertible Preferred Stock (“Series C Preferred”), and warrants to purchase up to 6.0 million shares of our common stock at an exercise price of $0.75 per share, for an aggregate purchase price of $6.0 million. Each share of Series C Stock has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.75 per share. The Series C Stock is initially convertible into an aggregate of 8,000,000 shares of our common stock, subject to certain limitations and adjustments.

 

We believe that our current cash resources, which include the proceeds of the March 2014 offering of Series C Stock, will enable us to fund our intended operations through May 2015.

 

Basis of Preparation and Summary of Significant Accounting Policies

 

Basis of Preparation — The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by U.S. generally accepted accounting principles for complete financial statements. The accompanying unaudited financial information should be read in conjunction with the audited consolidated financial statements, including the notes thereto, as of and for the year ended December 31, 2013, included in our 2013 Annual Report on Form 10-K filed with the SEC. The information furnished in this report reflects all adjustments (consisting of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. The results of operations for the three and six months ended June 30, 2014 are not necessarily indicative of the results for the year ending December 31, 2014 or for any future period.

 

Use of Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the

 

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United States of America requires our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting periods. Estimates having relatively higher significance include revenue recognition, stock-based compensation, valuation of warrants, valuation and estimated lives of identifiable intangible assets, impairment of long-lived assets, valuation of features embedded within note agreements and amendments, and income taxes. Actual results could differ from those estimates.

 

Fair Value of Financial Instruments —We consider the fair value of cash, restricted cash, accounts receivable, accounts payable and accrued liabilities to not 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 and restricted cash are subject to fair value measurement and are valued determined by Level 1 inputs. We measure and report at fair value our accrued restructuring liability using discounted estimated cash flows. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. We measure the liability for price adjustable warrants and certain features embedded in notes using the Black-Scholes-Merton valuation model, using Level 3 inputs. The following tables summarize our liabilities measured at fair value on a recurring basis as of December 31, 2013 and June 30, 2014:

  

       Level 1      Level 3 
   Balance at
December 31,
 2013
   Quoted prices in
active markets for
identical assets
   Level 2
Significant other
observable inputs
   Significant
unobservable
inputs
 
Liabilities:                    
Fair value liability for price adjustable warrants  $5,226   $-   $-   $5,226 
Fair value liability for shares to be issued   1,019    1,019    -    - 
Total liabilities at fair value  $6,245   $1,019   $-   $5,226 

  

   Balance at June
30, 2014
   Level 1
Quoted prices in
active markets for
identical assets
   Level 2
Significant other
observable inputs
   Level 3
Significant
unobservable
inputs
 
Liabilities:                    
Fair value liability for price adjustable warrants  $10,061   $-   $-   $10,061 
Total liabilities at fair value  $10,061   $-   $-   $10,061 

 

The following presents activity of the fair value liability of price adjustable warrants determined by Level 3 inputs for the six-month period from December 31, 2013 to June 30, 2014:

 

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       Weighted average as of each measurement date 
   Fair value
liability for price
adjustable warrants
(in thousands)
   Exercise
Price
   Stock
Price
   Volatility   Contractual
life
(in years)
   Risk free
rate
 
Balance at December 31, 2013  $5,226   $0.28   $0.40    124%   4.08    1.30%
Cashless exercise of warrants   (1,862)   0.28    1.17    131    3.24    0.78 
Warrant issuance in connection with Series C   5,928    0.75    1.50    121    2.08    0.64 
Change in fair value included in statement of operations   769    -    -    -    -    - 
Balance at June 30, 2014  $10,061   $0.38   $0.65    125%   3.09    0.90%

  

Net Income (Loss) per Common Share — Basic net income (loss) per share of common stock has been computed by dividing net income (loss) by the weighted average number of shares outstanding during the period. Diluted net income per share of common stock has been computed by dividing net income by the weighted average number of shares outstanding plus the diluting effect, if any, of outstanding stock options, warrants and convertible securities. Diluted net loss per share of common stock has been computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during such period. In a net loss period, options, warrants and convertible securities are anti-dilutive and therefore excluded from diluted loss per share calculations. The following have been excluded as they are anti-dilutive:

 

   Three Months Ended June 30,   Six Months Ended June 30, 
   2013   2014   2013   2014 
Stock options outstanding   284,829    284,505    284,829    284,505 
Warrants   12,916,801    7,031,058    1,306,058    21,310,695 
Convertible preferred stock -    -    -    8,000,000 
Total   13,201,630    7,315,563    1,590,887    29,595,200 

 

The following is a reconciliation of diluted weighted average shares outstanding:

  

   Three Months Ended
June 30,
   Six Months Ended June 30, 
(In thousands)  2013   2014   2013   2014 
Weighted average common shares outstanding   16,938    25,633    16,938    23,563 
Assumed conversion of net common shares issuable under warrants   -    9,066    650    - 
Assumed conversion of notes payable with conversion feature   -    -    5,397    - 
Assumed conversion of Series C Stock   -    102    -    - 
Weighted average common and common equivalent shares outstanding, diluted   16,938    34,801    22,985    23,563 

 

Recently Issued Accounting Standards — In May 2014, the Financial Accounting Standard Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers”, which provides guidance for revenue recognition. The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. This ASU also requires additional disclosures. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2016. We are currently in the process of evaluating the impact of adoption of this ASU on the financial statements.

 

In April 2014, the FASB issued ASU No. 2014-08, “Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity” which changes the criteria for determining which disposals can be presented as discontinued operations and modifies the related disclosure requirements. Under the new guidance, a disposal of a component of an entity or a group of components of an entity is required to be reported in discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results and is disposed of or classified as held for sale. The standard also introduces several new disclosures. The guidance applies prospectively to new disposals and new classifications of disposal groups as held for sale after the effective date. ASU 2014-08 is effective for annual and interim periods beginning after December 15, 2014, with early adoption permitted. We are currently in the process of evaluating the impact of adoption of this ASU on the financial statements.

 

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Note 2 — Notes Payable

 

In February 2014, the holders of the secured promissory notes that we originally issued in February 2012, exchanged notes in the aggregate principal and interest amount of approximately $1.5 million for approximately 2.0 million shares of our common stock. The excess of the fair value of the common stock issued over the carrying value of the notes and accrued interest of $0.97 million was recorded as non-cash interest expense.

 

During the three months ended March 2013, we recorded interest and other expenses related to the notes of $0.06 million, with interest on the notes being $0.03 million and extinguishment accounting charges being $0.03 million. During the three months ended March 31, 2014 and prior to debt conversion to equity in March 2014, we recorded interest charges of $1.0 million, including $0.97 million related to the exchange of the notes and accrued interest for common stock, with the remainder being interest on the notes prior to exchange. There was no interest expense in the three months ended June 30, 2014.

 

Note 3 — Stockholders’ Equity

 

Preferred Stock — Our board of directors has the authority, without action by the stockholders, to designate and issue up to 100,000 shares of preferred stock in one or more series and to designate the rights, preferences and privileges of each series, any or all of which may be greater than the rights of our common stock. We have 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, we designated 1,200 shares of Series C Convertible Preferred Stock (“Series C Stock”).

 

In March 2014, we entered into a Securities Purchase Agreement with certain investors pursuant to which we sold 1,200 shares of Series C Stock, and price adjustable warrants to purchase up to 6.0 million shares of our common stock at an exercise price of $0.75 per share, for an aggregate purchase price of $6.0 million. Each share of Series C Stock has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.75 per share. The Series C Stock is initially convertible into an aggregate of 8,000,000 shares of our common stock, subject to certain limitations and adjustments, has no stated dividend rate, is not redeemable and has voting rights on an as-converted basis.

 

To account for the issuance of the Series C Stock and warrants, we first assessed the terms of the warrants and determined that, due to certain antidilution provisions, they should be recorded as derivative liabilities. We determined the fair value of the warrants on the issuance date and recorded a liability of $6.5 million. Since the fair value of the warrants exceed the total proceeds received of $6.0 million, we recorded a loss of $0.5 million upon issuance which is included in the change in fair value of price adjustable warrants in the statement of operations. The discount of $6.0 million on the Series C Stock resulting from the allocation of the entire proceeds to the warrant was accreted as a dividend on the Series C Stock through the earliest conversion date, which was immediately. The Series C Stock dividend of $6.0 million was recorded as both a debit and a credit to additional paid-in capital and as a deemed dividend on the Series C Stock in determining net loss applicable to common stock holders in the statement of operations. We incurred $0.07 million of stock issuance costs in conjunction with the Series C Stock which were netted against the proceeds.

 

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

 

During the three months ended March 2014, we issued 0.1 million shares with a fair value of $0.01 million to a vendor under the terms of a 2012 compromise and release agreement.

 

In September 2012, as part of the lease termination agreement, we agreed to issue 1.5 million shares of our common stock to a landlord. The shares were issued in March 2014 at a value of $1.9 million.

 

As part of the asset purchase agreement that we entered into with Novosom in July 2010, we are obligated to pay Novosom 30% of any payments received by us for sub-licensed SMARTICLES® technology. The consideration is payable in a combination of cash (no more than 50% of total due) and common stock (between 50% and 100% of total due), at our discretion. For such consideration, we issued 0.96 million common shares with a fair value of $1.5 million in March 2014.

 

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In January 2014, we issued 2.7 million shares of common stock with fair value of $1.0 million to employees and board members in settlement of amounts due under certain employment agreements and accrued board fees.

 

In January 2014, we issued 0.08 million shares of common stock with a fair value of $0.03 million to directors and 0.1 million shares of common stock with a fair value of $0.03 million to scientific advisory board members for their services provided during the three months ended March 31, 2014.

 

In January 2014, we issued 0.03 million shares of common stock with a fair value of $0.01 million to two consultants as compensation for services provided during the three months ended March 31, 2014.

 

In April 2014, we issued 0.03 million shares of common stock with fair value of $0.03 million to a consultant and scientific advisory board members in settlement of amounts due under certain employment agreements and accrued board fees.

 

Warrants — In January 2014, we issued warrants to purchase up to 0.10 million shares of our common stock to a consultant who is our interim chief financial officer. These warrants vest over two years, have a fixed strike price of $0.48, expire in January 2024 and have an immaterial fair value.

 

In March 2014, in conjunction with the issuance of Series C preferred (see above), we issued price adjustable warrants to purchase up to 6.0 million shares of our common stock at an exercise price of $0.75 per share, for an aggregate purchase price of $6.0 million.

 

During the three months ended March 31, 2014, we issued approximately 1.2 million shares upon net share exercise of warrants.

 

In April 2014, we issued warrants to purchase up to 0.075 million shares of our common stock to a vendor. These warrants have a fixed strike price of $0.89, expire in January 2024 and have an immaterial fair value.

 

The following table summarizes warrant activity during the six months ended June 30, 2014:

  

   Warrant
Shares
   Weighted
Average
Exercise Price
 
Outstanding, December 31, 2013   17,017,601   $1.29 
Cashless exercises   (1,781,906)   0.38 
Issuance to vendor   6,075,000    0.75 
Outstanding, June 30, 2014   21,310,695   $1.21 
Expiring in 2014   64,382      
Expiring in 2015   285,345      
Expiring in 2016   6,000,000      
Expiring thereafter   14,960,968      

  

Note 4 — Stock Incentive Plans

 

At June 30, 2014, options to purchase up to 0.28 million shares of our common stock were outstanding.

 

Stock-based Compensation. Certain option and share awards provide for accelerated vesting if there is a change in control as defined in the applicable plan and certain employment agreements. The following table summarizes stock-based compensation expense:

 

   Three months ended June 30,   Six months ended June 30, 
(In thousands)  2013   2014   2013   2014 
Research and development  $11   $10   $22   $20 
General and administrative   17    10    35    20 
Total  $28   $20   $57   $40 

 

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Stock Options — Stock option activity was as follows:

 

   Options Outstanding 
   2014 
   Shares   Weighted Average
Exercise Price
 
Outstanding on January 1   284,829   $39.46 
Forfeitures   (324)  $426.83 
Outstanding on June 30   284,505   $39.02 
Exercisable as of June 30   266,532   $41.51 

 

The following table summarizes additional information on our stock options outstanding at June 30, 2014:

 

   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
 
$2.00 - $2.20   154,288    7.17   $2.02    136,316   $2.02 
$11.60 - $50.00   39,406    4.91    37.61    39,406    37.61 
$50.01 - $90.80   56,463    4.34    70.29    56,463    70.29 
$127.60 - $167.60   33,666    3.96    148.20    33,666    148.20 
$207.60 - $588.80   682    2.33    513.30    681    513.30 
Totals   284,504    5.90   $39.02    266,532   $41.51 
Exercisable   266,532    6.54                

 

No options were granted in the six months ended June 30, 2014.

 

At June 30, 2014, we had $0.02 million of total unrecognized compensation expense related to unvested stock options. We expect to recognize this cost over a weighted average period of five months.

 

At June 30, 2014, the intrinsic value of options outstanding or exercisable was zero as there were no options outstanding with an exercise price less than the per share closing market price of our common stock at that date. No options were exercised during the periods ended June 30, 2013 and 2014.

 

Note 5 — Intellectual Property and Collaborative Agreements

 

Tekmira — In November 2012, we and Tekmira entered into a license agreement pursuant to which Tekmira was granted a worldwide, non-exclusive and selectively sub-licensable license to develop and commercialize products using our UNA technology. We received a $0.3 million upfront payment and an additional $0.2 million received in April 2013. This agreement was transferred to Arcturus as part of the patent assignment and license agreement in August 2013.

 

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Novosom — In July 2010, we entered into an agreement pursuant to which we acquired the intellectual property for Novosom’s SMARTICLES-based liposomal delivery system. During 2013, as a result of the payment received from Mirna for additional compounds, we opted to record a $0.15 million cash payable and reserve an additional 0.45 million shares for future issuance. All balances due Novosom, both cash and stock, were paid or issued in March 2014.

 

Note 6 — Commitments and Contingencies

 

 Standby Letter of Credit/Leases — In connection with the lease of our Bothell, Washington facility, we provided the landlord a $1.2 million stand-by letter of credit. The landlord drew $0.38 million in rent charges from the letter of credit in January and February 2013, before the credit facility was terminated in March 2013. At March 1, 2013, the Company had exited all facility leases, and the only remaining commitment was to issue 1.5 million common shares to the landlord.

 

Contingencies — We are subject to various legal proceedings and claims that arise in the ordinary course of business. Our management currently believes that resolution of such legal matters will not have a material adverse impact on our consolidated financial position, results of operations or cash flows.

 

Note 7 — Subsequent Events

 

There have been no material subsequent events.

 

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ITEM 2 — MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Overview

 

Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by us. These factors include, but are not limited to: (i) the ability of our company to obtain additional and substantial funding in the future; (ii) the ability of our company to attract and/or maintain research, development, commercialization and manufacturing partners; (iii) the ability of our company and/or a partner to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (iv) the ability of our company and/or a partner to obtain required governmental approvals, including product and patent approvals; and (v) the ability of our company and/or a partner to develop and commercialize products that can compete favorably with those of competitors. In addition, significant fluctuations in quarterly results may occur as a result of the timing of milestone payments, the recognition of revenue from milestone payments and other sources, and the timing of costs and expenses related to our research and development programs. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in our filings with the Securities and Exchange Commission, including those factors discussed under the captions “Risk Factors” and “Forward-Looking Statements” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013, as may be supplemented or amended from time to time, which we urge investors to consider. We undertake no obligation to publicly release revisions in such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrences of unanticipated events or circumstances, except as otherwise required by securities and other applicable laws.

 

Background

 

We are a biotechnology company focused on the discovery, development and commercialization of nucleic acid-based therapies to treat orphan diseases. Since 2010, we have strategically acquired/in-licensed and further developed nucleic acid chemistry and delivery-related technologies to form an integrated drug discovery platform. We distinguish ourselves from others in the nucleic acid therapeutics area through this unique platform that enables the development of a variety of therapeutics targeting coding and non-coding RNA via multiple mechanisms of action such as RNA interference (“RNAi”), messenger RNA (“mRNA”) translational inhibition, exon skipping, miRNA (“miRNA”) replacement, miRNA inhibition, and steric blocking in order to modulate gene expression either up or down depending on the specific mechanism of action. Our goal is to dramatically improve the lives of the patients and families affected by orphan diseases through either our own efforts or those of our collaborators and licensees.

 

We are focusing our efforts and resources on the discovery and development of our own pipeline of nucleic acid-based compounds in order to commercialize drug therapies to treat orphan diseases. In addition, we will seek to establish collaborations and strategic partnerships with pharmaceutical and biotechnology companies to generate revenue through up-front, milestone and royalty payments related to our technology and/or the products that are developed using such technology.

 

Cash Position and Liquidity

 

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 June 30, 2014, we had an accumulated deficit of approximately $336 million. To the extent that sufficient funding is available, we will in the future continue to incur losses as we continue our research and development (“R&D”) activities. In addition, we have had and will continue to have negative cash flows from operations. We have funded our losses primarily through the sale of common and preferred stock and warrants, revenue provided from our license agreements with other parties, and, to a lesser extent, equipment financing facilities and secured loans. At June 30, 2014, we had a working capital surplus of $2.4 million, which included $4.3 million in cash.

 

On February 24, 2014, certain debt holders exchanged secured promissory notes in the aggregate principal and interest amount of $1.5 million for 2.0 million shares of our common stock. In addition, on March 7, 2014, we entered into a Securities Purchase Agreement with certain investors pursuant to which we sold 1,200 shares of Series C Stock, and warrants to purchase up to 6.0 million shares of our common stock at an exercise price of $0.75 per share, for an aggregate purchase price of $6.0 million. Each share of Series C Stock has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $0.75 per share. The Series C Stock is initially convertible into an aggregate of 8,000,000 shares of our common stock, subject to certain limitations and adjustments, has no stated dividend rate, is not redeemable and has voting rights on an as-converted basis.

 

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We believe that our current cash resources, which include the proceeds of the March 2014 offering of Series C Stock, will enable us to fund our intended operations through May 2015.

 

Cash flows

 

Our operating activities used cash of approximately $2.3 million in the six months ended June 30, 2014, compared to approximately $0.4 million in the six months ended June 30, 2013. In the six months ended June 30, 2014, cash used in operating activities related primarily to funding our operations and adjustments to non-cash components related to our debt extinguishment and interest charges totaling $1.0 million, to stock-based compensation of $0.1 million, and to non-cash changes in fair values of stock based liabilities totaling $3.2 million. Additionally, adjustments of $0.3 million were made for non-cash settlements on accrued expenses. Changes in operating assets and liabilities used $1.1 million mostly from reductions in accounts payable and accrued expenses. In the six months ended June 30, 2013, cash used in operating activities related primarily to funding our net income, adjusted for non-cash gains totaling $2.9 million related to changes in the fair value of the liability for price adjustable warrants, stock reserved to settle liabilities and embedded derivatives in notes payable. Non-cash expenses totaling $1.1 million included the loss on debt extinguishment, interest expense and stock compensation. Changes in operating assets and liabilities used $0.07 million mostly from changes in the accrued restructuring, other accrued liabilities and deferred revenue. The March 2014 funding of $6.0 million is being used to resume business and R&D activities. In the six months ended June 30, 2013, cash used in operating activities related primarily to funding our operations and adjusting for changes in the liabilities associated with our debt and price adjustable securities.

 

Our investing activities provided cash of approximately $0.4 million in the six months ended June 30, 2013 and we had no investing activities in the first six months of 2014. In the six months ended June 30, 2013, cash provided by investing activities was cash received from sales of property and equipment and a draw on restricted cash.

 

Our financing activities provided cash of $5.7 million in the six months ended June 30, 2014, compared to an immaterial amount in the six months ended June 30, 2013. Changes in cash from financing activities are primarily due to the sale of our Series C preferred shares and warrants to purchase common stock, offset by a cash payment required under the terms of the notes before they were retired.

 

Summary 

 

We believe that our current cash resources, which include the proceeds of the March 2014 offering of Series C Stock, will enable us to fund our intended operations through May 2015. The market value and the volatility of our stock price, as well as our historical financial situation and general market conditions, could make it difficult for us to complete a financing or collaboration transaction on favorable terms, or at all. Any financing we obtain may further, and substantially, dilute or otherwise impair the ownership interests of our current stockholders. If we fail to obtain significant additional capital in the future, we will be forced to further delay, reduce or eliminate some or all of our planned activities.

 

Consolidated Results of Operations

 

Comparison of the Results of Operations for the Three and Six Months Ended June 30, 2014 to the Three and Six Months Ended June 30, 2013

 

Revenue. We recorded no revenues in the six months ended June 2014. Revenue was $0.3 million in the three and six months ended June 30, 2013, of which $0.2 million was from Mirna Therapeutics and $0.1 million was from Tekmira. Revenue in 2013 consisted of upfront payments under our various agreements. 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 seek R&D collaborations as well as licensing transactions to fund business operations.

 

Research and Development. R&D expense consists primarily of salaries and other personnel-related expenses, costs of clinical trials and pre-clinical studies, consulting and other outside services, laboratory supplies, patent license fees, facilities costs and other costs. R&D expense declined 51% and 56% from $0.1 million and $0.22 million for the three and six months ended June 30, 2013 to $0.05 million and $0.1 million for the three and six months ended June 30, 2014, respectively, primarily resulting from the following:

 

·Personnel-related expenses (compensation, benefits, travel related) included a paid time off accrual reversal that resulted in a credit of $0.04 million and $0.03 million in the three and six months ended June 30, 2014 compared to expenses of $0.1 million and $0.2 million in the three and six months ended June 30, 2013. Decreases were also due to the transition of our chief scientific officer to the scientific advisory board.

 

·The resumption of development of the FAP program increased R&D consulting from immaterial amounts in 2013 to $0.05 million and $0.07 million in the three and six months ended June 30, 2014.

 

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·Additional R&D expenses are related to scientific advisory board fees, which started in 2014 and were $0.03 million and $0.05 million for the three and six months ended June 30, 2014.

 

In general, our strengthened financial position at March 31, 2014 has allowed us to subsequently increase R&D spending as we resume development of our FAP product. Development activity and external spending has increased, while employment changes have offset the increased spending, resulting in an overall decline in R&D expenses for the six months ended June 30, 2014 compared to the same period in 2013.

 

General and administrative. General and administrative (“G&A”) expense consists primarily of salaries and other personnel-related expenses to support our R&D activities, stock-based compensation for G&A personnel and non-employee members of our Board, professional fees, such as accounting and legal, corporate insurance and facilities costs. G&A costs increased by 54% and 86% from $0.4 million and $0.6 million in the three and six months ended June 30, 2013 to $0.6 million and $1.1 million in the three and six months ended June 30, 2014, respectively, primarily resulting from the following:

 

·Personnel-related expenses (compensation, benefits, travel related) decreased by 93% and 40% from $0.2 million and $0.4 million in the three and six months ended June 30, 2013 to $0.01 million and $0.2 million in the three and six months ended June 30, 2014. The decrease was due to the reversal of the previously accrued paid time off and the transition of our interim chief financial officer to the board of directors.

 

·Costs of legal and accounting fees, consulting, corporate insurance and other administrative costs increased by 169% and 61% from $0.2 million and $0.5 million in the three and six months ended June 30, 2013 to $0.5 million and $0.8 million in the three and six months ended June 30, 2014, primarily due to costs associated with regaining reporting compliance and audits.

 

·Included in G&A in the first half of 2013 was a credit of $0.3 million due to the reversal of a financing-related liability the payment of which was deemed remote.

 

·Costs associated with board of director compensation increased from an immaterial amount in 2013 to $0.06 million and $0.1 million in the three and six months ended June 30, 2014, respectively.

 

In general, G&A expenses increased in 2014 compared to 2013, due to the resumption of business operations, performing financial audits, and regaining reporting compliance with the Securities and Exchange Commission.

 

 Change in fair value liability for price adjustable securities.  The fair value liability is revalued each balance sheet date utilizing Black-Scholes-Merton model computations, with the decrease or increase in fair value being reported in the statement of operations as other income or expense, respectively. The change associated with this mark-to-fair value requirement resulted in a loss of $0.06 million and a gain of $2.0 million during the three and six months ended June 30, 2013, respectively. Stock price decreases resulted in a $4.5 million gain and stock price increases and the issuance terms of the Series C related warrants resulted in a $0.8 million loss during the three and six months ended June 30, 2014, respectively. The largest drivers of the change in the value of the liability are the number of price adjustable securities and the change in the stock price. Our stock price decreased $0.16 from January 1 to June 30, 2013, driving a gain on the consolidated statements of operations. Our stock price increased $0.49 from January 1 to March 31, 2014 and decreased $0.24 from March 1 to June 30, 2014. Additionally, we issued an additional 6 million price adjustable securities in March 2014, which drove the loss in the first three months to be largely offset by the gain in the second three months. An increase in stock price increases the liability and increases our loss on the consolidated statements of operations.

 

Change in fair value liability for stock to be issued. We recognized a loss of $2.5 million in the six months ended June 30, 2014 related to the change in fair value of the shares committed to be paid for services, for lease termination, and for license fees. We issued 2.5 million common shares at a fair value of $3.4 million in the first three months of 2014 to fulfill these contractual obligations.

 

Change in fair value of features embedded in notes payable. We recorded a gain of $0.6 million in the six months ended June 30, 2013 for the change in fair value of separately valued stand-alone features embedded in our notes payable. These features were revalued at each reporting period and the liability adjusted accordingly, with changes in the liability reflected as a gain or loss on the consolidated statements of operations. The change in the value of these features was tied to the stock price, such that price declines within the reporting period reduced the fair value of the liabilities and was recorded as a gain on the consolidated statements of operations. The gain was offset when substantially equivalent losses were incurred on debt extinguishment, as discussed below. The notes and all such features were extinguished in March 2014.

 

Loss on Debt Extinguishment. Due to the requirements under debt extinguishment accounting, the fair value of existing debt is extinguished on the date of certain note amendments. Any concurrent warrant issuances and the fair value of any embedded features within the notes are fully expensed as a gain or loss on extinguishment, then the note terms and features are revalued and rebooked on

 

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the balance sheet. In the six months ended June 30, 2013, a $0.9 million loss was recorded due to extinguishment of the debt related to the February 2013 amendment.

 

Gain on settled liabilities. During the six months ended June 30, 2014, we recorded a $0.3 million gain due to the negotiated settlement of liabilities. $0.26 million was a settlement on accrued compensation for our executive officers. The remaining liabilities to those officers of $1.0 million were paid through the issuance of 2.8 million common shares with a fair value of $1.0 million. The remaining $0.04 million was related to credits related to vendor payables.

 

Interest and other expense. During the six months ended June 30, 2014, we recorded $1.0 million in interest and other expense compared to $0.1 million in the three and six months ended June 30, 2013. The note amendments executed in 2013 required extinguishment accounting under which the fair value of the associated warrants was expensed on the date of the amendments. Interest expense in the three and six months ended June 30, 2013 represented accrued interest on the notes payable. Interest expense in the six months ended June 30, 2014 consisted of interest on the notes and a $0.97 million charge related to the beneficial conversion feature that allowed conversion at $0.75 per share rather than at the prevailing market price. There was no material interest expense in the three months ended June 30, 2014.

 

Off-Balance Sheet Arrangements

 

As of June 30, 2014, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.

 

ITEM 3 — QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4 — CONTROLS AND PROCEDURES

 

(a)  Disclosure Controls and Procedures. As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our senior management, including our principal executive officer and our principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective for gathering, analyzing and disclosing the information that we are required to disclose in reports filed under the Exchange Act.

 

(b) Internal Control Over Financial Reporting. Management has reported to the Board of Directors and the Audit Committee thereof material weaknesses described under the heading “Management Report on Internal Control” contained in Item 9A of the 2013 Form 10-K. The material weaknesses discussed therein have not been remediated. There have been no changes in our internal control over financial reporting or in other factors during the fiscal quarter ended June 30, 2014 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. However, our current and historical financial condition, loss of substantially all personnel, and cessation of day-to-day operations, particularly during the period covered by the 2013 Form 10-K and during subsequent reporting periods, including the period covered by this report, have placed substantial pressure on our system of internal control over financial reporting. With the availability of funds, we intend to put in place a stronger internal control process by hiring individuals or consultants to establish increased oversight on our financial reporting.

 

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PART II — OTHER INFORMATION

 

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

 

During the fiscal quarter ended June 30, 2014, we issued an aggregate of 29,752 shares of our common stock to the four members of our Scientific Advisory Board and to one consultant. The shares were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act.

 

ITEM 6 — EXHIBITS

 

The exhibits required by this item are set forth in the Exhibit Index attached hereto.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned, duly authorized, in Cambridge, Massachusetts, on August 19, 2014.

 

  MARINA BIOTECH, INC.
     
  By: /s/ J. Michael French
    J. Michael French
   

President and Chief Executive Officer

(Principal Executive Officer and

Principal Financial Officer)

 

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ITEM 6 —EXHIBIT INDEX

 

Exhibit
No.
  Description
     
31.1   Certification of our Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. (1)
     
32.1   Certification of our Principal Executive Officer and 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)
     
101.INS   XBRL Instance Document (2)
     
101.SCH   XBRL Taxonomy Extension Schema Document (2)
     
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document (2)
     
101.DEF   XBRL Taxonomy Extension Definitions Linkbase Document (2)
     
101.LAB   XBRL Taxonomy Extension Label Linkbase Document (2)
     
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document (2)

 

 

 

(1)Filed Herewith.
(2)Furnished Herewith.

 

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