-- Announced and closed the acquisition of Cequent Pharmaceuticals which will expand Marina Biotech's oncology pipeline with a pending Phase 1 human clinical trial in Familial Adenomatous Polyposis expected to begin in the third quarter, expanding our RNAi drug discovery platform capabilities with the addition of the transkingdomRNAi platform -- an orally delivered RNAi-based therapeutic approach to gastrointestinal diseases such as colon cancer and inflammatory bowel disease.Acquisition of Novosom AG Assets:
-- Acquired the intellectual property of Novosom AG for its SMARTICLES ® liposomal-based delivery system in an all-stock transaction further expanding Marina Biotech's RNA delivery platform IP estate.Acquisition of UNAs for Diagnostics:
-- Obtained exclusive rights to develop, make, use and sell UNA (Unlocked Nucleobase Analog)-based diagnostics from RiboTask ApS. Marina Biotech expanded its previous agreement with RiboTask for exclusive rights to the development of UsiRNA-based therapeutics to now include the development of UNA-based diagnostics.Advanced RNAi Oncology Programs:
-- Demonstrated increased tumor reduction when two UsiRNAs were combined within a single DiLA2 formulation. For a survivin/PLK1 combination, tumor bioluminescence and survivin mRNA expression was notably lower (~30% for each endpoint) when compared to a survivin alone (MRNA-046). Similar results for tumor bioluminescence and mRNA were found with the survivin/FGFR3 combination. With the survivin/HRAS combination there was a ~40% greater decrease in tumor bioluminescence and ~50% greater inhibition of survivin mRNA compared to MRNA-046 alone.Advanced RNAi Drug Discovery Platform:
-- Demonstrated that strategic placement of UNA (unlocked nucleobase analogs) within short-interfering RNAs, termed UsiRNAs, results in greater strand-specific activity and minimizes off-target activity when compared to standard siRNAs. -- Reported a second generation DiLA2 formulation, when paired with an UsiRNA construct delivered via systemic injection, resulted in 50% knockdown of Factor VII (FVII) protein at a 80 microgram per kilogram dose.Advanced R&D Collaboration Opportunities:
-- Announced a research study with Pfizer (Advanced Intellectual Property Portfolio:NYSE :PFE ). The relationship is focused on the evaluation of Marina Biotech's proprietary DiLA2 platform and UsiRNA constructs for RNAi. -- In total, Marina Biotech is currently supporting five early collaborative efforts, including the Pfizer and AstraZeneca relationships.
-- The acquisition of the Cequent and Novosom intellectual property patent estates provides Marina Biotech with a global portfolio including 61 issued or allowed patents; 56 U.S. patent applications; 146 foreign patent applications; and 8 PCT applications providing broad coverage for siRNAs, chemistry, delivery and gene targets. -- Expanded Marina Biotech's proprietary UNA intellectual property portfolio by acquiring exclusive rights to UNA-based diagnostics. -- Acquired intellectual property for conformationally restricted nucleotides (CRN) (formerly called bridged nucleic acids) from Valeant Pharmaceuticals North America. CRN's enable Marina Biotech to tailor key characteristics of UsiRNA constructs to impart greater versatility and specificity. In addition, the technology gives the opportunity to pursue single-stranded and antagomir therapeutic approaches. -- Intellectual Property Office of New Zealand (IPONZ) issued a Notice of Acceptance for patent application 553828, titled "Methods of Treating an Inflammatory Disease by Double-Stranded Ribonucleic Acid" with allowed claims that cover small interfering RNAs (siRNA) directed against tumor necrosis factor (TNF); further developing a patent portfolio that is both comprehensive and distinct from other RNAi companies. -- European Patent Office delivered a notice of Intent to Grant a patent entitled "Compositions for Bacterial Mediated Gene Silencing and Methods Using Same," and the Korean Intellectual Property Office delivered a Notice of Decision for Patent of the same title. Allowed genus claims cover attenuated bacteria (such as modified E.coli) as a therapeutic engine for the delivery of short interfering RNA (siRNA) molecules against disease-related genes, including cancer genes such as beta-catenin, whose up-regulation is implicated in the formation and proliferation of colorectal and other cancers.Presented at Numerous Scientific and Investor Meetings and Conferences:
-- Presented at the following scientific meetings: American Association for Cancer Research 101st Annual Meeting 2010; Digestive Disease Week; IBC Life Sciences' TIDES® 2010; 4th Annual RNAi & miRNA World Congress; 15th Annual Meeting of the RNA Society, RNA2010; and Liposomes 2010. -- Presented at the following investor meetings: 2010 BIO Business Forum; MDB Capital Group Bright Lights; Rodman & Renshaw 6th Annual Global Healthcare Conference; 9th Annual Needham Healthcare Conference; BMO Capital Markets 10th Annual Focus on Healthcare Conference; and CANACCORD/Genuity 30th Annual Global Growth Conference 2010.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 June 30, 2010. The call is scheduled for Thursday, August 12, at 4:30 pm Eastern Time (1:30 pm Pacific Time). To participate in the live conference call, U.S. residents should dial 800-265-0241 and international callers should dial 617-847-8704. The participant code for the live conference call is 17358335. 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 39898166. 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 (formerly known as MDRNA, Inc.) is a biotechnology company, focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Marina Biotech's pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and two preclinical programs -- in hepatocellular carcinoma and bladder cancer. Marina Biotech's goal is to improve human health through the development of RNAi-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 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 under MDRNA Inc. Marina Biotech assumes no obligation to update and supplement forward-looking statements because of subsequent events.
MARINA BIOTECH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended Six Months Ended
June 30, June 30,
2009 2010 2009 2010
--------- --------- --------- ---------
(Unaudited)(Unaudited)(Unaudited)(Unaudited)
License and other revenue $ 309 $ 193 $ 14,460 $ 377
--------- --------- --------- ---------
Operating expenses:
Research and development 4,340 3,837 8,456 7,436
Selling, general and
administrative 2,251 2,248 4,358 4,807
Restructuring 178 260 311 286
--------- --------- --------- ---------
Total operating expenses 6,769 6,345 13,125 12,529
--------- --------- --------- ---------
Income (loss) from operations (6,460) (6,152) 1,335 (12,152)
Other income (expense):
Interest income 1 - 3 -
Interest and other expense (168) (544) (311) (1,324)
Net gain on settlement of
liabilities - - 654 -
Change in fair value price
adjustable warrants (905) 2,595 (1,932) (115)
--------- --------- --------- ---------
Net loss $ (7,532) $ (4,101) $ (251) $ (13,591)
========= ========= ========= =========
Basic and diluted net loss per
share:
Net loss per common share -
basic and diluted $ (0.84) $ (0.34) $ (0.03) $ (1.13)
========= ========= ========= =========
Shares used in computing net
loss per share - basic and
diluted 8,991 12,219 8,528 12,027
========= ========= ========= =========
December 31, June 30,
Selected Balance Sheet Data (In Thousands) 2009 2010
(Unaudited) (Unaudited)
Cash
(includes restricted cash of $998 and
$1,157, respectively) $ 1,746 $ 2,231
Accounts Receivable, net 211 110
Property and Equipment and Other Assets 5,272 4,272
------------ ------------
Total Assets 7,229 6,613
============ ============
Notes Payable, net of Discount 317 2,005
Fair Value Liability for Price Adjustable
Warrants 7,243 10,078
Other Liabilities 6,555 7,726
------------ ------------
Total Liabilities 14,115 19,809
============ ============
Accumulated Deficit (263,017) (276,608)
============ ============
Contact Information: Contacts: Marina Biotech, Inc.: Peter Garcia Chief Financial Officer (425) 908-3603 pgarcia@marinabio.com Westwicke Partners (Investors): Stefan Loren, Ph.D. (443) 213-0507 sloren@westwicke.com John Woolford (443) 213-0506 john.woolford@westwicke.com McKinney|Chicago (Media): Alan Zachary (312) 944-6784 x 316 or (708) 707-6834 azachary@mckinneychicago.com