0001193125-12-121541.txt : 20120319 0001193125-12-121541.hdr.sgml : 20120319 20120319160503 ACCESSION NUMBER: 0001193125-12-121541 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20120313 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120319 DATE AS OF CHANGE: 20120319 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: 12700668 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 d314437d8k.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): March 13, 2012

 

 

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

N/A

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 1.01 Entry Into a Material Definitive Agreement.

On March 13, 2012, Marina Biotech, Inc. (the “Company”) and ProNAi Therapeutics, Inc. (“ProNAi”) entered into an Exclusive License Agreement (the “License Agreement”) regarding the development and commercialization of DNAi-based therapeutics utilizing the Company’s novel SMARTICLES® liposomal delivery technology. The License Agreement provides that ProNAi will have full responsibility for the development and commercialization of any products arising under the License Agreement. Under terms of the License Agreement, the Company could receive up to $14 million for each gene target in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, with ProNAi having the option to select any number of additional gene targets. Either party may terminate the License Agreement upon the occurrence of a default by the other party (subject to standard cure periods), or upon certain events involving the bankruptcy or insolvency of the other party. ProNAi may also terminate the License Agreement without cause upon ninety (90) days’ prior written notice to the Company, provided that no such termination shall be effective sooner than December 13, 2012.

The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the License Agreement. The omitted material will be included in the request for confidential treatment.

The foregoing summary is qualified in its entirety by reference to the License Agreement, a redacted copy of which will be attached as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012.

On March 14, 2012, the Company issued a press release announcing that it has entered into the License Agreement, a copy of which is attached to this Current Report as Exhibit 99.1 and incorporated herein by reference.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On March 16, 2012, the Company and Philip C. Ranker entered into an amendment to that certain Employment Agreement, effective as of September 7, 2011, by and between the Company and Mr. Ranker, pursuant to which Mr. Ranker serves as the interim Chief Financial Officer and Secretary of the Company. The purpose of the amendment was to extend Mr. Ranker’s employment period under the employment agreement from March 7, 2012 to September 7, 2012, and to make certain conforming changes to the employment agreement in connection with such extension. Except as otherwise expressly provided by the amendment, all of the terms and conditions of the employment agreement are, and shall continue to be, in full force and effect. A copy of the amendment is attached to this Current Report as Exhibit 10.1 and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits:

 

Exhibit No.

 

Description

10.1**   Amendment No. 1, effective as of March 7, 2012, to the Employment Agreement, effective as of September 7, 2011, by and between the Registrant and Philip C. Ranker.
99.1   Press release of Marina Biotech, Inc. dated March 14, 2012.

 

** Indicates management contract.


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 hereunto duly authorized.

 

   

Marina Biotech, Inc.

March 19, 2012

    By:  

/s/ J. Michael French

    Name:        J. Michael French
    Title:        Chief Executive Officer


EXHIBIT INDEX

 

Exhibit No.

 

Description

10.1**   Amendment No. 1, effective as of March 7, 2012, to the Employment Agreement, effective as of September 7, 2011, by and between the Registrant and Philip C. Ranker.
99.1   Press release of Marina Biotech, Inc. dated March 14, 2012.

 

** Indicates management contract.
EX-10.1 2 d314437dex101.htm AMENDMENT NO.1 TO THE EMPLOYMENT AGREEMENT Amendment No.1 to the Employment Agreement

Exhibit 10.1

AMENDMENT TO EMPLOYMENT AGREEMENT

THIS AMENDMENT (this “Amendment”) to that certain Employment Agreement (the “Employment Agreement”), effective as of September 7, 2011, by and between Philip C. Ranker (the “Executive”) and Marina Biotech, Inc., a Delaware corporation (the “Company”), is made effective as of March 7, 2012.

WHEREAS, the Company and the Executive entered into the Employment Agreement to set forth the terms of the Executive’s employment by the Company during an Employment Period commencing on September 7, 2011 and terminating at the close of business on March 7, 2012; and

WHEREAS, the Company and the Executive desire to amend the Employment Agreement, pursuant to Section 22 of the Employment Agreement, to, among other things described in this Amendment, extend the Employment Period to September 7, 2012.

NOW, THEREFORE, in consideration of the mutual covenants contained in this Amendment and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Executive hereby agree as follows:

 

  1. Section 3 of the Employment Agreement is hereby deleted in its entirety and replaced in its entirety with the following: “Term; Employment Period. The “Employment Period” under this Agreement shall commence on the Effective Date and shall terminate at the close of business on September 7, 2012 unless it is (a) extended by written agreement between the parties or (b) earlier terminated pursuant to Section 10 hereof.”

 

  2. In connection with the extension of the Employment Period as described in Section 1 of this Amendment, the reference to “March 7, 2012” in clause (iv) of Section 10(d) of the Employment Agreement is hereby amended to be a reference to “September 7, 2012”. In addition, the third sentence of Section 7 of the Employment Agreement is hereby deleted in its entirety and replaced in its entirety with the following: “The Company shall reimburse Executive for reasonable travel expenses to and from Executive’s home residence in San Diego, CA to and from Bothell, WA until the expiration of the Employment Period.”

 

  3.

The first parenthetical in each of Section 17(b) and Section 17(d) of the Employment Agreement is hereby deleted in its entirety and replaced in its entirety with the following: “(and only if the Executive’s employment is terminated by the Company for Cause)”. In addition, the reference to “twelve (12) months” in Section 17(c) of the Employment Agreement is


  hereby replaced by a reference to “six (6) months”, and the references to “collaborative partners, consultants, certified research organizations, principal vendors and licensees” in Section 17(c) of the Employment Agreement are hereby deleted in their entirety.

For purposes of the Employment Agreement and this Amendment, any reference to “directly competitive” means a company, product, activity, or any other aspect of the industry that may be subject to limitations as set forth in the aforementioned agreements that are, in their entirety, nucleic acid-based or pertaining to the delivery or other aspect of a nucleic acid-based therapeutic. For the avoidance of doubt, if the Company were to develop a cardiovascular therapeutic, a company, product, activity, or other aspect of the industry would only be considered directly competitive if it involves a nucleic acid-based therapeutic exclusively. All other cardiovascular research and development or commercial efforts would not be considered directly competitive.

 

  4. Except as otherwise expressly provided by this Amendment, all of the terms and conditions of the Employment Agreement are, and shall continue to be, in full force and effect and are hereby ratified and confirmed in all respects.

 

  5. Capitalized terms used but not defined in this Amendment shall have the meanings ascribed to such terms in the Employment Agreement.

 

  6. This Amendment shall be construed in accordance with and governed for all purposes by the laws of the State of Washington applicable to contracts made and to be performed wholly within such State, without regard to the principles of conflicts of laws thereof.

 

  7. This Amendment may be executed in two or more counterparts, each of which shall be considered one and the same amendment and shall become effective when counterparts have been signed by each party and delivered to the other party. In the event that any signature is delivered by facsimile transmission or by an e-mail which contains a portable document format (.pdf) file of an executed signature page, such signature page shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such signature page were an original thereof.

 

  8. This Amendment shall be effective upon the Company’s execution and receipt of the same amendment executed by the Executive.

[remainder of page intentionally left blank; signature page follows]

 

2


IN WITNESS WHEREOF, the parties have caused this Amendment to be duly executed by their respective authorized signatures as of the date first set forth above.

 

MARINA BIOTECH, INC.

By:

 

/s/ J. Michael French

Name:

       J. Michael French

Title:

       President and Chief Executive Officer

Date:

       March 16, 2012

 

/s/ Philip C. Ranker

Name:

  Philip C. Ranker

Date:

  March 12, 2012

 

3

EX-99.1 3 d314437dex991.htm PRESS RELAESE Press Relaese

Exhibit 99.1

 

LOGO    LOGO

Marina Biotech and ProNAi Therapeutics Announce License

Agreement for the Development of DNAi-based Therapeutics

- ProNAi Therapeutics will develop oncology-focused compounds utilizing its proprietary DNAi

technology combined with Marina Biotech’s novel SMARTICLES® liposomal delivery

technology -

Bothell, WA and Ann Arbor, MI March 14, 2012 – Marina Biotech, Inc. (OTCQX: MRNA), a leading nucleic acid-based drug discovery and development company, and ProNAi Therapeutics, Inc. (ProNAi), a privately-held biotechnology company pioneering DNA interference (DNAi) therapies for cancer, announced today that the Companies have entered into an Exclusive License Agreement regarding the development and commercialization of DNAi-based therapeutics utilizing Marina Biotech’s novel SMARTICLES® liposomal delivery technology. ProNAi will have full responsibility for the development and commercialization of any products arising under the Agreement. Under terms of the Agreement, Marina Biotech could receive up to $14 million for each gene target in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, with ProNAi having the option to select any number of additional gene targets. For example, if ProNAi licenses five products over time under this Agreement, Marina Biotech could receive up to $70 million in total milestones, plus royalties. Further terms of the Agreement were not disclosed.

“We are pleased that twenty-two patients have been dosed with PNT2258 in our Phase I clinical trial in advanced solid tumor patients to evaluate safety and tolerability, maximum tolerated dose, pharmacokinetics and pharmacodynamics. PNT2258 is our first DNAi oligonucleotide targeted against the anti-apoptotic bcl-2 oncogene and encapsulated in Marina’s SMARTICLES® technology. This novel delivery technology offers protection for the DNAi oligonucleotide during systemic administration with good circulation times and extrahepatic tumor exposure. DNAi are short single-strand unmodified oligonucleotides designed to silence genes by interfering with DNA. The DNAi silencing approach is differentiated from that of RNAi, antisense or miRNA in that it targets genomic sequences within noncoding region of DNA disrupting transcription. The progress and delivery validation in the clinic this past year on the novel DNAi-SMARTICLES® formulation gives us confidence to bring forward more first in class drug candidates alone or with partners. ProNAi is now positioned to advance additional cancer therapies from its pre-clinical leads targeting other oncogenes such as c-myc and k-ras while also exploring other disease targets in areas such as inflammation and genetics diseases,” said Charles L. Bisgaier, Ph.D., President and CEO of ProNAi Therapeutics.

“We are extremely pleased to have entered into a relationship with a company like ProNAi who is developing a first-in-class nucleic acid therapeutic,” stated J. Michael French, President and CEO of Marina Biotech. “In addition, we are excited to see the continued advancement of

 

1


oligonucleotide-based therapeutics using our SMARTICLES® technology. Besides advancements within our own internal research programs, we have now been able to establish two license agreements broadening the application of the SMARTICLES® technology to the systemic administration of both single and double-stranded oligonucleotide therapeutics. We look forward to the rapid advancement of ProNAi Therapeutics’ clinical pipeline and the opportunity to bring novel therapeutics to patients in need.”

ProNAi is conducting an open-label, single arm, Phase I dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists at START in San Antonio Texas. PNT2258 is ProNAi’s first drug candidate from the DNAi drug platform. Patients receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). ProNAi plans to report the results of this Phase I study at oncology conferences later this year and initiate the next Phase I/II safety and efficacy studies in select cancer patients based upon the safety and dose findings from this Phase I study.

About Marina Biotech, Inc.

Marina Biotech is a biotechnology company focused on the development and commercialization of oligonucleotide-based therapeutics utilizing multiple mechanisms of action including RNA interference (RNAi) and messenger RNA translational blocking. 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 entered into an exclusive agreement with The Debiopharm Group for the development and commercialization of the bladder cancer program. In addition, Marina Biotech has entered into an agreement with Mirna Therapeutics to license Marina Biotech’s SMARTICLES® technology for the delivery of microRNA mimics. Marina Biotech's goal is to improve human health through the development of RNAi- and oligonucleotide-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.

About ProNAi Therapeutics, Inc.

ProNAi Therapeutics, Inc. is a venture backed, clinical stage, biotech company pioneering a new class of targeted drugs based on utilizing single strands of unmodified DNA oligonucleotides to target genomes responsible for complex, proliferative diseases initially in cancer. The Company’s lead drug candidate, PNT2258, has demonstrated safety and in vivo efficacy in a variety of preclinical tumor xenograft models. The company has successfully raised over $20 million from Apjohn Ventures, Grand Angels, the State of Michigan, Biosciences Research and Commercialization Center (BRCC), Amherst Fund and private investors. Additional information about ProNAi Therapeutics is available at http://www.pronai.com.

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

 

2


cause actual results to differ materially from those in forward-looking statements 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 prior to, and 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.

Forward-Looking 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 include, but are not limited to: (i) the ability of ProNAi to obtain additional funding; (ii) the ability of ProNAi Therapeutics to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of ProNAi and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of the ProNAi Therapeutics and/or a partner to obtain required governmental approvals; and (v) the ability of ProNAi Therapeutics and/or a partner to develop and commercialize products that can compete favorably with those of competitors.

Marina Biotech, Inc.

Philip Ranker

Interim Chief Financial Officer

(425) 908-3615

pranker@marinabio.com

ProNAi Therapeutics, Inc.

Wendi Rodrigueza, Ph.D.

Vice President, Product Development

(269) 815-8098

wrodrigueza@pronai.com

 

3

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