-- Reported positive in vivo efficacy data showing that MDRNA's
proprietary UsiRNA constructs are highly potent and highly specific against
ApoB and Factor VII message
-- Reported positive in vivo data from a bladder cancer model
demonstrating effective localized delivery of a UsiRNA to a solid tumor
-- Reported data showing that UsiRNA constructs increase stability and
reduce off-target activity and cytokine induction
-- Initiated pre-clinical studies in non-human primates using a
proprietary UsiRNA formulated with the Company's DiLA(2) delivery
technology
-- Appointed Peter S. Garcia as the Company's new Chief Financial Officer
-- Raised net proceeds of $9.3 million in a registered direct offering
-- Repaid all remaining debt to GE Capital Corporation
-- Regained compliance with NASDAQ's requirements for continued listing
on the NASDAQ Global Market
-- Established a new Scientific Advisory Board and appointed Beverly L.
Davidson, Ph.D., and Carl Novina, M.D., Ph.D., as its initial members
-- Resized the Company's Board of Directors consistent with MDRNA's focus
as a preclinical stage drug discovery company and appointed Director James
E. Rothman, Ph.D., as Scientific Advisor to the Board of Directors
-- Announced FDA approval of generic calcitonin-salmon nasal spray for
treatment of osteoporosis and launch by Par Pharmaceuticals in June 2009
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, 2009. The call is
scheduled for Thursday, July 30, 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 800-510-9836 and international callers should dial
617-614-3670. The participant code for the live conference call is
45176872. 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 73400458. 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 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 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.
Financial Tables Follow
MDRNA, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2009 2008 2009
--------- --------- --------- ---------
(Unaudited)
Revenue
License and research fees $ 431 $ 306 $ 1,113 $ 14,374
Product revenue 241 --- 729 70
Government grants 82 3 175 16
--------- --------- --------- ---------
Total revenue 754 309 2,017 14,460
--------- --------- --------- ---------
Operating expenses:
Cost of product revenue 2,665 --- 2,829 ---
Research and development 8,493 4,340 19,419 8,456
Selling, general and
administrative 3,825 2,251 8,627 4,358
Restructuring --- 178 1,917 311
--------- --------- --------- ---------
Total operating expenses 14,983 6,769 32,792 13,125
--------- --------- --------- ---------
Income (loss) from operations (14,229) (6,460) (30,775) 1,335
Other income (expense):
Interest income 135 1 428 3
Interest expense (237) (168) (502) (311)
Net gain on settlement of
liabilities --- --- --- 654
Change in fair value of
price adjustable warrants --- (905) --- (1,932)
--------- --------- --------- ---------
Net loss $ (14,331) $ (7,532) $ (30,849) $ (251)
========= ========= ========= =========
Basic and diluted net loss per
share:
Net loss per common share --
basic and diluted $ (0.48) $ (0.21) $ (1.10) $ (0.01)
========= ========= ========= =========
Shares used in computing net
loss per share - basic and
diluted 29,722 35,962 27,966 34,113
========= ========= ========= =========
December 31, June 30,
Selected Balance Sheet Data (In Thousands) 2008 2009
------------ ------------
(Unaudited)
Cash and Cash Equivalents
(includes restricted cash of $2,268 and
$1,451, respectively) $ 3,352 $ 9,377
Accounts Receivable, net 32 60
Property and Equipment, Inventories and Other
Assets 9,753 6,298
------------ ------------
Total assets 13,137 15,735
============ ============
Fair Value of Liability for Price Adjustable
Warrants --- 10,820
Other Liabilities 16,396 5,868
------------ ------------
Total Liabilities 16,396 16,688
============ ============
Accumulated deficit (254,085) (255,222)
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 or (708) 707-6834