-- Announced that Barry Polisky, Ph.D., will join MDRNA as Chief
Scientific Officer effective January 2, 2009;
-- Selected a highly potent Lead Candidate Dicer substrate siRNA
(MDR-04227) in the ApoB hypercholesterolemia program;
-- Strengthened our intellectual property estate with the acquisition
of intellectual property from RiboTask ApS pertaining to Unlocked
Nucleic Acids, the use of which results in an improved siRNA activity
profile;
-- Exclusively in-licensed intellectual property from the University of
Michigan covering cationic peptides for enhanced delivery of nucleic
acids;
-- Received an extension of our grant from the National Institutes of
Health totaling more than $350,000 for research in RNA inhibition of
influenza;
-- Entered into a collaboration with the University of Helsinki for the
discovery of novel peptides that may facilitate tissue and tumor
delivery and improved cellular uptake of siRNAs into specific organs
and cells using our proprietary Trp Cage phage display library;
-- Presented positive in vivo efficacy data on two Lead Candidate siRNAs
at two scientific conferences:
-- Dicer substrate siRNA (MDR-03030) against seasonal and pandemic flu
strains at the XIV International Congress on Virology -- Data
showed 99 percent reduction in viral titers and 100 percent
survival benefit against Avian Flu;
-- Dicer substrate siRNA (MDR-04227) targeting ApoB combined with our
novel DiLA2 delivery platform at the RNAi Society's "RNA 2008"
meeting -- Data showed approximately 85 percent knockdown in target
messenger RNA of ApoB and a similar level of reduction of serum
cholesterol following a single 1 mg/kg dose of siRNA.
Conference Call and Webcast Information
Management will host a conference call to review financial results for the
period ended September 30, 2008, and recent business developments. The call
is scheduled for today, November 13, 2008, at 4:30 p.m. Eastern Time (1:30
p.m. Pacific Time). To participate in the live conference call, U.S.
residents should dial 800-573-4754 and international callers should dial
617-224-4325. The access code for the live conference call is 30077222. To
access the 24-hour telephone replay, U.S. residents should dial
888-286-8010 and international callers should dial 617-801-6888. The access
code for the replay is 54844146. Alternatively, to access the live audio
webcast for this conference call, please go to MDRNA's Web site at
http://www.mdrnainc.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 following the event.
About MDRNA, Inc. MDRNA is a biotechnology company focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Our 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. Over the past decade, we have developed substantial capabilities in molecular biology, cellular biology, lipid chemistry, peptide chemistry, pharmacology and bioinformatics, which we are applying to a wide range of RNAi technologies and delivery approaches. These capabilities plus the in-licensing of key RNAi-related intellectual property have rapidly enabled us to become a leading RNAi-based therapeutics company with a pre-clinical pipeline in key therapeutic areas including oncology, metabolic disorders and inflammation. Through our capabilities, expertise and know-how, we are incorporating multiple RNAi technologies as well as peptide- and lipid-based delivery approaches into a single integrated drug discovery platform that will be the engine for our clinical pipeline as well as a versatile platform for establishing broad therapeutic partnerships with biotechnology and pharmaceutical companies. We are also investing in new technologies that we expect to lead to safer and more effective RNAi-based therapeutics while aggressively building upon our broad and extensive intellectual property estate. By combining broad expertise in siRNA science with proven delivery platforms and a strong IP position, MDRNA is well positioned as a leading RNAi-based drug discovery and development company. Additional information about MDRNA, Inc. is available at http://www.mdrnainc.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 cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of MDRNA, Inc. or a subsidiary to obtain additional funding; (ii) the ability of MDRNA, Inc. or a subsidiary to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of MDRNA, Inc., a subsidiary and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of MDRNA, Inc., a subsidiary and/or a partner to obtain required governmental approvals; and (v) the ability of MDRNA, Inc., a subsidiary 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 our most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. We assume no obligation to update and supplement forward-looking statements because of subsequent events. Financial Tables Follow
MDRNA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2008 2007 2008
--------- --------- --------- ---------
(Unaudited)
Revenue
License and research fees $ 1,792 $ 100 $ 11,197 $ 1,213
Government grants 105 62 307 237
Product revenue --- 243 245 972
--------- --------- --------- ---------
Total revenue 1,897 405 11,749 2,422
--------- --------- --------- ---------
Operating expenses:
Cost of product revenue,
including non-cash
inventory write-down of
$0 and $2,579 in the three
and nine months ended
September 30, 2008,
respectively --- 77 68 2,906
Research and development 13,774 7,603 39,412 27,022
Selling, general and
administrative 5,090 2,502 14,490 11,129
Restructuring --- 6,167 --- 8,084
--------- --------- --------- ---------
Total operating expenses 18,864 16,349 53,970 49,141
--------- --------- --------- ---------
Loss from operations (16,967) (15,944) (42,221) (46,719)
Other income (expense):
Interest income 817 69 2,722 497
Interest and other expense (300) (195) (858) (697)
--------- --------- --------- ---------
Net Loss $ (16,450) $ (16,070) $ (40,357) $ (46,919)
========= ========= ========= =========
Basic and diluted net loss per
share:
Net loss per common share --
basic and diluted $ (0.66) $ (0.52) $ (1.62) $ (1.62)
========= ========= ========= =========
Shares used in computing net
loss per share - basic and
diluted 25,067 31,003 24,844 28,986
========= ========= ========= =========
December 31, September 30,
Selected Balance Sheet Data (In Thousands) 2007 2008
(Unaudited)
Cash, cash equivalents and investments
(includes restricted cash of $2,155) $ 41,573 $ 10,874
Accounts receivable, net 324 ---
Property and equipment, inventories and
other assets 19,719 10,387
Total assets 61,616 21,261
Working capital 31,111 1,511
Accumulated deficit (194,865) (241,784)
Stockholders’ equity 39,220 5,323
Contact Information: Contact: Matthew D. Haines Senior Director, Investor Relations and Corporate Communications (212) 209-3874 McKinney|Chicago (Media) Alan Zachary (312) 944-6784 x 316 (708) 707-6834