-- Hired Barry Polisky, Ph.D., as Chief Scientific Officer. Dr. Polisky
previously served as Research Vice President at Merck & Co. and Chief
Scientific Officer at Sirna Therapeutics where he led the research and
development of RNAi-based therapeutics.
Validated RNAi Drug Discovery Platform through multiple Pharma Licensing
Deals
-- Entered into a worldwide, non-exclusive sublicense agreement with
Roche for MDRNA's siRNA constructs and chemistry platform;
-- Entered into a worldwide, non-exclusive licensing agreement with
Novartis for MDRNA's liposomal technology platform for siRNA delivery.
Additionally, the companies have entered into a separate agreement, which
provides Novartis with an exclusive period to negotiate a research and
development collaboration and broader licensing rights related to MDRNA's
RNAi drug delivery platform.
Corporate Restructuring Accomplishments
-- Eliminated rent obligations from January 2009 until July 2010 on the
Company's excess facility in Bothell, Washington through a previously
disclosed lease amendment;
-- Significantly reduced previously disclosed employee-related cash
severance payments for both a one-time cash payment due in June 2009 as
well as continuing severance payments through September 2009;
-- Significantly reduced the Company's ongoing monthly payments to
General Electric Capital Corporation on leased equipment and leasehold
improvements by restructuring the debt into a Loan and Security Agreement;
-- Our restructuring, renegotiation and cost containment efforts will
result in cash utilization of approximately $5.5 million beginning in the
second quarter of 2009, a greater than 25% reduction compared to the fourth
quarter of 2008.
Monetized Legacy Nasal Assets
-- Received tentative approval by the FDA for generic calcitonin-salmon
nasal spray for osteoporosis and are preparing for commercial launch in mid-
2009. The Company will receive profits related to the commercial sale of
the product through the Company's partner Par Pharmaceutical;
-- Received an accelerated $1.0 million milestone payment from Amylin
Pharmaceuticals for advancement of the intranasal exenatide program by
amending a 2006 Development and Licensing Agreement. Under terms of the
amended agreement, MDRNA could receive up to an additional $79 million in
future milestones and royalties;
-- Engaged Adjuvant Global Advisors, LLC to identify potential licensing
opportunities for MDRNA's intranasal delivery clinical programs in Asia and
Europe.
SCIENTIFIC ACCOMPLISHMENTS IN THE COMPANY'S RNAI DRUG DISCOVERY PROGRAM
-- Reported positive in vivo data on the Company's proprietary RNAi drug
discovery engine at multiple international meetings and conferences.
The Company reported:
-- Systemically delivered meroduplex siRNAs were: (1) well tolerated;
(2) effective against multiple liver targets when delivered
systemically, and (3) inhibited tumor growth when applied topically
for bladder cancer. Keystone Symposia's RNAi, MicroRNA, and
Non-coding RNA Meeting;
-- Robust activity in a mouse model following a single IV
administration of MDRNA's meroduplexes targeting apolipoprotein B
(ApoB) mRNA formulated in a DiLA(2) delivery vehicle. The meroduplex
siRNA decreased both ApoB mRNA and serum cholesterol levels. In
addition, the formulated, chemically modified siRNA resulted in
minimal body weight loss in mice while showing reduced levels of
cytokine stimulation. "RNA 2008," the 13th Annual Meeting of the
RNA Society;
-- Positive efficacy data demonstrating a 100 to 1000-fold (99%)
reduction in viral titers of influenza A virus in animal models
with the Company's proprietary RNAi-based therapeutic for the
treatment of multiple strains of influenza. XIV International
Congress of Virology;
-- Positive efficacy data demonstrating up to 90% knockdown of ApoB
and reduced serum cholesterol with the Company's proprietary
unlocked nucleobase analogs siRNAs (UsiRNA) in animal models.
Informa Life Sciences 9th Annual Conference, EuroTIDES;
-- Positive data demonstrating a dose response, which resulted in up
to 90% knockdown of ApoB message in a rodent model using UsiRNAs
targeting multiple metabolic targets. Informa Life Sciences TIDES
Oligonucleotide and Peptide, Research, Technology and Product
Development Conference.
-- Refocused the Company's pipeline efforts on a single indication --
hepatocellular carcinoma (liver cancer) -- to maximize the use of
capital and increase the potential success of pre-clinical studies
and early stage human clinical trials.
BROADENED AND ENHANCED THE COMPANY'S INTELLECTUAL PROPERTY ESTATE
-- Filed multiple patent applications, including intellectual property
rights, that:
-- expanded protection for the Company's DiLA(2) delivery platform;
-- added novel chemistries to MDRNA's growing patent portfolio; and
-- further expanded the Company's target IP for siRNA therapeutics;
-- Acquired the intellectual property related to Unlocked Nucleobase
Analog (UNA) technology from RiboTask ApS thereby increasing the
breadth of the Company's technology platform by providing additional,
novel RNA chemistries;
-- Terminated the Company's 2006 license agreement with City of Hope for
technology and intellectual property related to Dicer substrates and
will focus on the development of the Company's proprietary and solely
owned UsiRNA and meroduplex constructs.
Conference Call and Webcast Information
Management will host a conference call to review financial results for the
period ended December 31, 2008, and recent business developments. The call
is scheduled for Tuesday, March 24, 2009, at 8:30 a.m. Eastern Time (5:30
a.m. Pacific Time). To participate in the live conference call, U.S.
residents should dial 866-356-4441 and international callers should dial
617-597-5396. The participant code for the live conference call is
88132749. 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 27372871. 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 for 30 days 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).
The Company's goal is to improve human health by combining novel RNAi-based
compounds and proprietary peptide- and liposomal-based drug delivery
technologies to provide superior therapeutic options. MDRNA's
multi-disciplinary portfolio of capabilities includes molecular biology,
cellular biology, formulation expertise, peptide and alkylated amino acid
chemistry, pharmacology, toxicology and bioinformatics. The Company is
applying this expertise to a single, integrated drug discovery platform
that will be the engine for its clinical pipeline and a versatile platform
for establishing broad therapeutic partnerships. MDRNA is also building on
new technologies, such as UsiRNAs that incorporate the non-nucleotide
moiety Unlocked Nucleobase Analog (UNA) within the siRNA molecule, that it
expects to lead to safer and more effective RNAi-based therapeutics. By
combining broad expertise in siRNA science with proven delivery platforms
and a strong and growing IP position, MDRNA is well positioned as a leading
RNAi therapeutics company and value-added collaborator for our research
partners. Additional information about MDRNA, Inc. is available at
http://www.mdrnainc.com.
MDRNA Forward-Looking Statement
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 to
obtain additional funding; (ii) the ability of MDRNA to attract and/or
maintain manufacturing, research, development and commercialization
partners; (iii) the ability of MDRNA and/or a partner to successfully
complete product research and development, including preclinical and
clinical studies and commercialization; (iv) the ability of MDRNA and/or a
partner to obtain required governmental approvals; and (v) the ability of
MDRNA 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 MDRNA's most recent
periodic reports on Form 10-K and Form 10-Q that are filed with the
Securities and Exchange Commission. MDRNA assumes no obligation to update
and supplement forward-looking statements because of subsequent events.
MDRNA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended Years Ended
December 31, December 31,
2007 2008 2007 2008
--------- --------- --------- ---------
(Unaudited)
Revenue
License and research fees $ 6,152 $ 147 $ 17,349 $ 1,360
Government grants 126 40 433 277
Product revenue 110 -- 355 972
--------- --------- --------- ---------
Total revenue 6,388 187 18,137 2,609
--------- --------- --------- ---------
Operating expenses:
Cost of product revenue,
including non-cash inventory
write-down of $0 and $2,579
in the three and twelve
months ended December 31,
2008, respectively 32 -- 100 2,906
Research and development 12,842 9,749 52,254 36,771
Selling, general and
administrative 5,824 2,488 20,314 13,617
Restructuring -- 173 -- 8,257
--------- --------- --------- ---------
Total operating expenses 18,698 12,410 72,668 61,551
--------- --------- --------- ---------
Loss from operations (12,310) (12,223) (54,531) (58,942)
Other income (expense):
Interest income 586 22 3,308 519
Interest and other expense (291) (100) (1,149) (797)
--------- --------- --------- ---------
Net Loss $ (12,015) $ (12,301) $ (52,372) $ (59,220)
========= ========= ========= =========
Basic and diluted net loss per
share:
Net loss per common share --
basic and diluted $ (0.47) $ (0.39) $ (2.10) $ (2.01)
========= ========= ========= =========
Shares used in computing net
loss per share - basic and
diluted 25,444 31,147 24,995 29,529
========= ========= ========= =========
December 31, December 31,
Selected Balance Sheet Data (In Thousands) 2007 2008
(Unaudited) (Unaudited)
Cash, cash equivalents and investments
(includes restricted cash of $2,155 and $2,268,
respectively) $ 41,573 $ 3,352
Accounts receivable, net 324 32
Property and equipment, inventories and other
assets 19,719 9,753
Total assets 61,616 13,137
Total liabilities 22,396 16,396
Accumulated deficit (194,865) (254,085)
Contact Information: Matthew D. Haines Senior Director, Investor Relations and Corporate Communications (212) 209-3874 McKinney|Chicago (Media) Alan Zachary (312) 944-6784 x 316 or (708) 707-6834