|By Marketwired .||
|December 6, 2012 06:30 AM EST||
BOTHELL, WA -- (Marketwire) -- 12/06/12 -- Marina Biotech, Inc. (PINKSHEETS: MRNA), a leading RNAi-based drug discovery and development company, yesterday reported financial results for the nine months ended September 30, 2012, and provided an update on 2012 corporate accomplishments.
"We continue to rebuild the company, and improve shareholder value through a combination of deal-based, non-dilutive financing and aggressive expense management," stated J. Michael French, President and Chief Executive Officer of Marina Biotech. "In the past six weeks, we have: (1) completed a licensing transaction bringing the total number of revenue-generating licensing agreements thus far this year to four; (2) been issued a key U.S. patent for our Unlocked Nucleobase Analog chemistry which allows us and our licensees to pursue multiple RNA-based oligonucleotide therapeutics in the RNAi and microRNA sectors; and, (3) completed the filings necessary so that we are now current in our periodic reporting under the Securities Exchange Act for the year. In addition, our licensee ProNAi reported that our SMARTICLES® delivery technology was shown to effectively and safely deliver oligonucleotides to tumors in a Phase 1 human clinical study. However, we still need significant additional capital to execute our strategy to be the single broadest nucleic acid drug discovery company in the industry. To that end, we continue to seek financing as well as both deal-based and strategic transaction opportunities to fund our operations and advance our clinical and preclinical programs. While there are still significant hurdles on our path toward success and there is no guarantee that we will survive or continue operating as an independent company, our team remains focused and dedicated to our stakeholders and to the development of unique nucleic acid-based therapeutics for the treatment of human disease."
Net loss for the nine months ended September 30, 2012 was approximately $5.5 million compared to a net loss of $11.6 million for same period in 2011. The decrease in our net loss is primarily a result of a decrease in operating expenses.
Revenue for the nine months ended September 30, 2012 was approximately $2.9 million compared to $0.6 million in 2011. In the 2012 period we recognized collaborative revenue from agreements with Monsanto, Novartis, and Mirna while revenue in the 2011 period included payments from Debiopharm and Mirna.
Research and development ("R&D") expenses decreased 50% from approximately $9.1 million for the nine months ended September 30, 2011 to $4.5 million for the same period of 2012. The decreases were due primarily to personnel-related expenses and direct R&D spending. On June 1, we announced that we had ceased substantially all day-to-day operations. Substantially all of our employees have been terminated since June 1, and our internal research and development efforts have been minimal, pending receipt of adequate funding.
Selling, general and administrative expenses for the nine months ended September 30, 2012 decreased 49% compared to the same period of 2011 from approximately $6.5 million to $3.3 million.
Restructuring expense for the nine months ended September 30, 2012 was approximately $1.5 million, compared to $1.4 million in the same period of 2011. The 2012 expense relates primarily to charges associated with our facility at 3830 Monte Villa Parkway. In September 2012, we sold most of the remaining property and equipment at the 3830 Monte Villa Parkway facility and abandoned the leasehold improvements at that facility. We terminated our lease for this facility effective October 1, 2012 and expect to record additional restructuring charges related to the termination in the fourth quarter of 2012. Earlier in 2012, we closed our Cambridge site and recorded restructuring expense of approximately $35,000. In 2011 we terminated the lease for our facility at 3450 Monte Villa Parkway and issued shares to the landlord.
Interest and Other Expense
For 2012 we recorded interest and other expense of approximately $2.5 million consisting primarily of non-cash amortization of the debt discount resulting from the fair value of price adjustable warrants issued to note holders. We did not record any interest or other expense in 2011.
We recorded net gains of approximately $3.3 million in the nine months ended September 30, 2012 and net gains of approximately $4.7 million in the same period of 2011 related to the re-measurement of price-adjustable warrants and subscription investment units required to be classified as liabilities. The liability is re-measured at the end of each accounting period, and increases or decreases with changes in our stock price and variables in our valuation model.
As of September 30, 2011 we had cash of approximately $1.1 million, including approximately $0.7 million of restricted cash compared to $2.1 million, including $1.0 million of restricted cash as of December 31, 2011.
In the first nine months of 2012, we recognized revenue from upfront payments and other payments from collaborative partners totaling $2.9 million, executed an agreement for a secured loan in the aggregate principal amount of $1.5 million, currently due at the end of the year, and raised net proceeds of approximately $1.1 million in a public stock offering. We believe that our current resources will be sufficient to fund our planned, limited operations only until the end of 2012 without securing additional funding.
CORPORATE ACCOMPLISHMENTS IN 2012
- In March 2012, we entered into an exclusive license agreement with ProNAi Therapeutics, Inc., a privately-held biotechnology company pioneering DNA interference (DNAi) therapies for cancer, regarding the development and commercialization of DNAi-based therapeutics utilizing our novel SMARTICLES®-based liposomal delivery technology.
- In May 2012, we entered into a worldwide exclusive license agreement with Monsanto Company, a global leader in agriculture and crop sciences, covering the agricultural applications for our delivery and chemistry technologies.
- In May 2012, we entered into a strategic alliance with Girindus Group, a recognized leader in process development, analytical method development and cGMP manufacture of oligonucleotide therapeutics, regarding the development, supply and commercialization of certain oligonucleotide constructs using our conformationally restricted nucleotide ("CRN") technology.
- In August 2012, we entered into a worldwide, non-exclusive license agreement with Novartis Institutes for Biomedical Research, Inc., a global leader in the development of human therapeutics, regarding the development of oligonucleotide therapeutics utilizing our CRN technology.
- In November 2012, we entered into a worldwide, nonexclusive license agreement with Tekmira Pharmaceuticals Corporation, a leader in the development of RNAi-based therapeutics, regarding the development of RNA interference therapeutics utilizing our Unlocked Nucleobase Analog (UNA) technology.
- In December 2012, we announced that the U.S. Patent and Trademark Office (USPTO) had issued a key patent expanding protection to our Unlocked Nucleobase Analog (UNA) modification and substitution chemistry. The claims of the patent broadly cover the use of a UNA in a number of RNA-based oligonucleotides including an siRNA (either RISC or Dicer length), a microRNA mimic, a microRNA antagonist, and an RNA-binding RNA steric blocker.
- In December 2012, we announced that our licensee ProNAi Therapeutics, Inc. reported statistically significant, dose-dependent, and specific knockdown of the Bcl-2 gene with suppression of protein levels up to 60 percent using our proprietary nucleic acid delivery technology, SMARTICLES®, in patients with advanced solid tumors for which no standard therapy exists. Patients received the drug for extended periods of time without having material side effects as seen with other anti-Bcl-2 drugs or nucleic acid cancer drugs in development.
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 myotonic dystrophy. Marina Biotech has entered into an agreement with both Mirna Therapeutics and ProNAi Therapeutics to license Marina Biotech's SMARTICLES® technology for the delivery of microRNA mimics and DNAi, respectively. In addition, Marina Biotech announced exclusive licensing agreements with Monsanto Company for Marina Biotech's delivery and chemistry technologies and with Girindus America for the supply of CRN-based oligonucleotides. Marina Biotech recently entered into non-exclusive agreements with Novartis Institutes for Biomedical Research and Tekmira Pharmaceuticals to license Marina Biotech's CRN and UNA nucleic acid modification chemistries, respectively. 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.
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 and substantial funding in the immediate future; (ii) the ability of Marina Biotech to attract and/or maintain research, development, commercialization and manufacturing 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.
J. Michael French
Chief Executive Officer
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