0001193125-11-141013.txt : 20110516 0001193125-11-141013.hdr.sgml : 20110516 20110516130919 ACCESSION NUMBER: 0001193125-11-141013 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110516 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110516 DATE AS OF CHANGE: 20110516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Marina Biotech, Inc. CENTRAL INDEX KEY: 0000737207 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 112658569 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-13789 FILM NUMBER: 11845038 BUSINESS ADDRESS: STREET 1: 3830 MONTE VILLA PARKWAY CITY: BOTHELL STATE: WA ZIP: 98021 BUSINESS PHONE: 4259083600 MAIL ADDRESS: STREET 1: 3830 MONTE VILLA PARKWAY CITY: BOTHELL STATE: WA ZIP: 98021 FORMER COMPANY: FORMER CONFORMED NAME: MDRNA, Inc. DATE OF NAME CHANGE: 20080610 FORMER COMPANY: FORMER CONFORMED NAME: NASTECH PHARMACEUTICAL CO INC DATE OF NAME CHANGE: 19920703 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): May 16, 2011

 

 

Marina Biotech, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-13789   11-2658569

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

3830 Monte Villa Parkway, Bothell,

Washington

  98021
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: 425-908-3600

Not Applicable

Former name or former address, if changed since last report

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On May 16, 2011, Marina Biotech, Inc. (the “Company”) reported its financial results for the fiscal quarter ended March 31, 2011. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The information contained herein and in the accompanying exhibit is being furnished pursuant to “Item 2.02 Results of Operations and Financial Condition.” The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


SIGNATURES

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

 

    Marina Biotech, Inc.
May 16, 2011     By: /s/ Peter S. Garcia                                                                         
    Name:     Peter S. Garcia
    Title:     Chief Financial Officer


Exhibit Index

 

Exhibit No.

  

Description

99.1    Press Release of Marina Biotech, Inc. dated May 16, 2011.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

Marina Biotech, Inc. Announces First Quarter 2011

Financial Results

Highlights First Quarter and Recent Corporate Accomplishments

Bothell, WA, May 16, 2011 – Marina Biotech, Inc. (Nasdaq: MRNA), a leading RNAi-based drug discovery and development company, today reported financial results for the first quarter ended March 31, 2011, and highlighted recent corporate accomplishments.

“We recently completed the 28 day dosing of the first patient enrolled in our START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) trial and the remaining two enrolled patients in cohort 1 are dosing,” stated J. Michael French, President and Chief Executive Officer of Marina Biotech. “We expect to conclude cohort 1 dosing by mid-June placing us solidly on our timeline to complete the dose escalating phase by year end. We also expect to be able to provide interim safety data on a cohort-by-cohort basis throughout this phase of the clinical trial. In addition, we are advancing the bladder cancer program with our partner the Debiopharm Group as well as continuing multiple early collaborative efforts with several of our proprietary technologies. With the solid progress in both our FAP clinical program and externally funded pre and clinical-stage programs utilizing multiple siRNA and delivery technologies, we feel we are in an excellent position to execute on both our pipeline and partnering objectives for the year.”

FINANCIAL RESULTS

Net loss

Net loss for the first quarter of 2011 was approximately $3.7 million or $0.12 per share, compared to approximately $9.5 million or $0.80 per share for the same period of 2010.

Revenue

Revenue was approximately $0.2 million for both the first quarter of 2011 and 2010. In February 2011, we announced an exclusive agreement with Debiopharm for the development and commercialization of our pre-clinical program in bladder cancer. The agreement funds the current and future development of the bladder cancer program up to an agreed upon amount and up to $24 million in future milestones as well as royalties on net sales.

 

- 1 -


Expenses

Research and development (“R&D”) expenses decreased 7% in the first quarter of 2011 compared to the prior year quarter, due primarily to a decrease in patent license fees. Direct project related spending and salaries expenses increased from the first quarter of 2010 as we advanced our RNAi therapeutics pipeline, including our lead program with CEQ508, and due to an increase in R&D personnel as a result of our acquisition of Cequent Pharmaceuticals in July 2010.

Selling, general and administrative (“SG&A”) expenses for the first quarter of 2011 decreased 26% to approximately $1.9 million compared to $2.6 million, for the same period in 2010, primarily as a result of a decrease in transaction costs incurred relating to our acquisition of Cequent in 2010. Excluding the $0.6 million in merger-related costs, SG&A expenses decreased slightly from the first quarter of 2010.

Restructuring expense includes accretion of the liability we have recorded for our exited facility along with facility-related charges and adjustments to the liability. The expense for the first quarter of 2011 was approximately $0.2 million due primarily to an adjustment to the subleasing assumptions for our restructuring liability.

Interest and Other Expense

We did not incur any interest and other expense in the first quarter of 2011. We recorded interest and other expense of approximately $0.8 million in the first quarter of 2010 which related primarily to the non-cash amortization of debt discount resulting from the fair value of price adjustable warrants issued to note holders. The underlying notes payable were paid in full in January 2010.

Other Income/(Expense)

We recorded a net gain of approximately $1.6 million and net expense of $2.7 million in the first quarter of 2011 and 2010, respectively, related to the re-measurement of price-adjustable warrants and subscription investment units required to be classified as liabilities. The liabilities are re-measured at the end of each accounting period, and increase or decrease with changes in our stock price and other variables in our valuation model.

Balance Sheet

As of March 31, 2011 we had cash of approximately $2.3 million compared to $2.1 million, as of December 31, 2010. As a result of our cash position and other factors, we received a “going concern” opinion from KPMG LLP, our independent registered public accounting firm, on our 2010 financial statements, which was included in our 10-K for the 2010 fiscal year.

 

- 2 -


FIRST QUARTER AND RECENT CORPORATE ACCOMPLISHMENTS

Advanced RNAi Clinical Program:

 

 

Announced the completion of enrollment in the first cohort of the dose escalating phase of our START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) Phase 1b/2a clinical trial with CEQ508.

 

 

Presented results from a 281 day non-human primate long-term toxicology study showing no test article related toxicities and a No Observed Adverse Effect Level of 1011 cfu/day. The results were presented at the 102nd Annual AACR Meeting.

Advanced RNAi Drug Discovery Platform:

 

 

Published pre-clinical research in Molecular Therapeutics, a Nature publication, on gene specific silencing of Survivin and PLK1 in a bladder cancer rodent model resulting in up to a 60-fold decrease in tumor volume.

 

 

Published pre-clinical research in Molecular Therapeutics, a Nature publication, on systemic delivery of siRNAs using our proprietary DiLA2 delivery technology.

 

 

Reported data demonstrating significant knockdown, up to 90%, of target mRNA in an orthotopic model of malignant ascites with our proprietary UsiRNA construct and DiLA2-based delivery system.

Advanced Partnering and R&D Collaboration Opportunities:

 

 

Announced an exclusive agreement with the Debiopharm Group for the development and commercialization of our pre-clinical program in bladder cancer. The agreement funds the current and future development of the bladder cancer program up to an agreed amount and up to $24 million in future milestones as well as royalties on net sales.

 

 

In total, we are currently supporting four early collaborative efforts, including AstraZeneca.

Advanced Intellectual Property Portfolio:

 

 

Continued to advance our global intellectual property portfolio which now includes 67 issued or allowed patents; 43 U.S. patent applications; 135 foreign patent applications; and 6 PCT applications providing broad coverage for siRNAs, chemistry, delivery and gene targets:

 

   

Announced notice of allowance for patent application U.S. 12/114,284 (now U.S. 7,939,505) covering our proprietary DiLA2 delivery platform;

 

   

Announced that the Australian Patent Office has issued a Notice of Allowance for patent application AU2005316458 with claims that broadly cover attenuated bacteria as a therapeutic platform for the delivery of short interfering RNA (siRNA) molecules that target disease-related genes (tkRNAi platform);

 

   

Announced that the Canadian Patent Office has issued a Notice of Allowance for patent application 2,438,116 with claims that broadly cover amphoteric liposomal formulations (SMARTICLES®) and their use for the delivery of nucleic acids and other compounds with therapeutic application;

 

- 3 -


   

Announced that the Japanese Patent Office has issued patent application 2007-509522 covering our proprietary nucleic acid condensing and delivery peptide motifs adding to our global peptide-based delivery patent portfolio.

Presented at Scientific and Investor Meetings and Conferences:

 

 

Presented at the following scientific meetings: AACR 102nd Annual Meeting and 3rd Annual Asia TIDES.

 

 

Presented at the following investor and partnering meetings: 10th Annual Needham Healthcare Conference; ROTH 23rd Annual OC Growth Conference; 13th Annual BIO CEO Conference; and Biotech Showcase 2011.

Conference Call and Webcast Information

Management will host a conference call to provide a business update and to review financial results for the quarter ended March 31, 2011. The call is scheduled for Monday, May 16, at 4:30 pm Eastern Time (1:30 pm Pacific Time).

To participate in the live conference call, U.S. residents should dial 866-202-4683 and international callers should dial 617-213-8846. The participant code for the live conference call is 77951141. To access the 24-hour telephone replay, U.S. residents should dial 888-286-8010 and international callers should dial 617-801-6888. The participant code for the replay is 23196622.

Alternatively, to access the live audio webcast for this conference call, please go to Marina Biotech’s Web site at http://www.marinabio.com approximately 15 minutes prior to the conference call in order to register and download any necessary software. A replay of the webcast will be available for 30 days following the event.

About Marina Biotech, Inc.

Marina Biotech is a biotechnology company, focused on the development and commercialization of RNA interference- (RNAi) and RNA-based therapeutics. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and two preclinical programs — in bladder cancer and malignant ascites. Marina Biotech has recently entered an exclusive agreement with the Debiopharm Group for the development and commercialization of the bladder cancer program. Marina Biotech’s goal is to improve human health through the development of RNAi and RNA-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Additional information about Marina Biotech is available at http://www.marinabio.com.

Marina Biotech Forward-Looking Statements

Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements

 

- 4 -


include, but are not limited to: (i) the ability of Marina Biotech to obtain additional funding; (ii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (v) the ability of Marina Biotech and/or a partner to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech’s most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update and supplement forward-looking statements because of subsequent events.

###

Contacts:

Marina Biotech, Inc.:

Peter Garcia

Chief Financial Officer

(425) 908-3603

pgarcia@marinabio.com

Financial Tables Follow

 

- 5 -


MARINA BIOTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In Thousands, Except Per Share Data)

 

     Three Months Ended
March 31,
 
     2010     2011  

Revenue

   $ 184      $ 214   
                

Operating expenses:

    

Research and development

     3,599        3,350   

Selling, general and administrative

     2,559        1,903   

Restructuring

     26        228   
                

Total operating expenses

     6,184        5,481   
                

Loss from operations

     (6,000     (5,267

Other income (expense):

    

Interest and other expense

     (780     —     

Change in fair value of price adjustable warrants and subscription investment units

     (2,710     1,602   
                

Net loss

   $ (9,490   $ (3,665
                

Basic and diluted net loss per share:

    

Net loss per common share — basic and diluted

   $ (0.80   $ (0.12
                

Shares used in computing net loss per share – basic and diluted

     11,832        31,090   
                

 

Selected Balance Sheet Data (In Thousands)    December 31,
2010
    March 31,
2011
 
     (Unaudited)  

Cash

(includes restricted cash of $1,017 and $1,157, respectively)

   $ 2,083      $ 2,281   

Accounts Receivable

     59        —     

Property and Equipment and Other Assets

     4,567        4,109   

Intangible Assets

     22,734        22,734   
                

Total Assets

     29,443        29,124   
                

Fair Value Liabilities for Price Adjustable Warrants and Subscription Investment Units

     3,266        967   

Deferred Tax Liabilities

     1,202        1,202   

Other Liabilities

     7,806        7,673   
                

Total Liabilities

     12,274        9,842   
                

Accumulated Deficit

     (290,770     (294,435
                

 

- 6 -

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