-- 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.
Advanced the RNAi Drug Discovery Platform and RNAi Pipeline
-- 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;
-- 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.
Restructured Key Elements of the Company
-- 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
-- Sold the Company's manufacturing facilities in Hauppauge, New York as
well as the Company's Abbreviated New Drug Application (ANDA) for generic
calcitonin-salmon nasal spray to Par Pharmaceuticals. Under the terms of
the Agreement, MDRNA received upfront cash and will receive profit sharing
on commercial sales of calcitonin. In addition, Par assumed MDRNA's supply
and manufacturing obligations as well as all operating costs associated
with the facilities;
-- 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.
Conference Call and Webcast Information
Management will host a conference call to review financial results for the
quarter ended March 31, 2009 and recent business developments. The call is
scheduled for Friday, May 15, 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 866-761-0748 and international callers should dial
617-614-2706. The participant passcode for the live conference call is
95089155. 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 passcode for the replay is 40891910. 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.
Financial Tables Follow
MDRNA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended
March 31,
2008 2009
--------- ---------
(Unaudited)
Revenue
License and research fees $ 682 $ 14,068
Product revenue 488 70
Government grants 93 13
--------- ---------
Total revenue 1,263 14,151
--------- ---------
Operating expenses:
Cost of product revenue 164 ---
Research and development 10,926 4,116
Selling, general and administrative 4,802 2,107
Restructuring 1,917 133
--------- ---------
Total operating expenses 17,809 6,356
--------- ---------
Income (loss) from operations (16,546) 7,795
Other income (expense):
Interest income 293 2
Interest expense (265) (143)
Net gain on settlement of liabilities --- 654
Change in fair value of price adjustable warrants --- (1,027)
--------- ---------
Net income (loss) $ (16,518) $ 7,281
========= =========
Basic and diluted net loss per share:
Net income (loss) per common share -- basic and
diluted $ (0.63) $ 0.23
========= =========
Shares used in computing net loss per share - basic
and diluted 26,211 32,243
========= =========
December 31, March 31,
Selected Balance Sheet Data (In Thousands) 2008 2009
(Unaudited)
Cash and cash equivalents
(includes restricted cash of $2,268
and $2,155, respectively) $ 3,352 $ 7,687
Accounts receivable, net 32 13
Property and equipment, inventories and
other assets 9,753 7,670
Total assets 13,137 15,370
Total liabilities 16,396 11,256
Accumulated deficit (254,085) (247,690)
Contact Information: Contacts: 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