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) |
Registrants 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 Companys 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 Companys 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. Rankers 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. |
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 Executives 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 Executives 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 Executives 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 Companys execution and receipt of the same amendment executed by the Executive. |
[remainder of page intentionally left blank; signature page follows]
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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 |
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Exhibit 99.1
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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 Biotechs 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 Biotechs 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 Marinas 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
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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 ProNAis 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 Biotechs 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 Companys 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
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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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