Tekmira Provides Corporate Update and Announces Third Quarter 2013 Results
Conference Call at 4:30 pm Eastern Time Today
VANCOUVER, British Columbia, Nov. 13, 2013 (GLOBE NEWSWIRE) -- Tekmira
Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of
RNA interference (RNAi) therapeutics, today announced its financial and
operating results for the third quarter ended September 30, 2013 and provided
a corporate update.
*We completed an underwritten public offering of 4,312,500 shares inclusive
of over-allotment at a price of US$8.00 per share for aggregate gross
proceeds of US$34.5million.
*On October 8, 2013, we hosted a webinar outlining five key development
programs within our pipeline of RNAi therapeutics. We are also currently
evaluating several preclinical candidates in diverse therapeutic areas,
with a focus on rare diseases where the molecular target is found in the
*Mr. Bruce Cousins joined Tekmira as Executive Vice President and Chief
Financial Officer, effective October 7, 2013.
*Dr. Mark Kowalski joined Tekmira as Chief Medical Officer effective August
*We presented updated TKM-PLK1 data at the 6th Annual NET Conference hosted
by the North American Neuroendocrine Tumor Society (NA-NETS) held in
Charleston, South Carolina on October 4, 2013.
*New preclinical data from the TKM-Ebola program has been generated showing
survival in primates despite infection with the most lethal "Zaire" strain
of the Ebola virus and delayed treatment.
*Preclinical data were presented at DIA/FDA Oligonucleotide-based
Therapeutics Conference held in Washington, DC on September 25, 2013
demonstrating potent anti-viral activity of TKM-Marburg and showing 100%
survival in non-human primates infected with the Angola strain of the
*Preclinical data demonstrating Tekmira's ongoing lipid nanoparticle (LNP)
technology innovations, including the effective enablement of messenger
RNA (mRNA), were presented at the 1st International mRNA Health Conference
held in Tubingen, Germany from October 23-24, 2013.
*Two articles were published in peer-reviewed scientific journals — the
Journal of Infectious Diseases and New England Journal of Medicine —
highlighting results enabled by Tekmira's LNP technology.
*Our licensee, Spectrum Pharmaceuticals, Inc., announced that it launched
Marqibo® through its existing hematology sales force in the United States.
*On November 10, 2013, Alnylam Pharmaceuticals, Inc. disclosed that it had
initiated a Phase III trial with LNP-enabled ALN-TTR02, also known as
patisiran, and the associated US$5 million milestone payment to Tekmira
has now been triggered.
"We've seen significant headway on our product pipeline, coupled with
meaningful preclinical data announced in the quarter. In addition, we
completed a successful financing fortifying our balance sheet. With this
financing risk now behind us, we are heavily focused on the execution of our
development plans. I am particularly pleased with the financing, as it
represents our first meaningful placement with U.S. institutional investors.
We appreciate the strong support and look forward to reporting back our
progress with our development projects," said Dr. Mark J. Murray, Tekmira's
President and CEO.
For the first nine months of 2013, net loss was $11.8 million ($0.82 per
common share) as compared to a net loss of $8.5 million ($0.63 per common
share) for the first nine months of 2012. For third quarter of 2013, net loss
was $6.1 million ($0.42 per common share) as compared to a net loss of $3.4
million ($0.25 per common share) for the third quarter of 2012.
Revenue was $3.0 million for the third quarter of 2013 as compared to $3.0
million for the third quarter of 2012.
Under a DoD contract to develop TKM-Ebola, Tekmira is being reimbursed for
costs incurred, including an allocation of overheads, and is being paid an
incentive fee. For this contract, Tekmira recorded $2.9 million in revenue in
the third quarter of 2013 and $1.9 million in third quarter of 2012.
In the third quarter of 2012, Tekmira earned a $1.0 million milestone from
Talon when they received accelerated approval for Marqibo from the U.S. Food
and Drug Administration (FDA). Spectrum, who acquired Talon in July 2013,
began commercial sales of Marqibo in September 2013.
Research, development, collaborations and contracts expenses
Research, development, collaborations and contracts expenses were $5.7 million
in the third quarter of 2013 as compared to $3.1 million in the third quarter
Development expenses have increased in the quarter as the company advances
multiple product candidates into the clinic. The Company has been incurring
more early stage research expense as it works to identify and qualify
additional drug candidates for development. R&D salary expense has also
increased as Tekmira has hired staff in a number of areas supporting
development of Tekmira's product candidates.
General and administrative
General and administrative expenses were $1.0 million in the third quarter of
2013 as compared to $1.5 million in the third quarter of 2012. Third quarter
of 2012 general and administrative expenses were higher as they included legal
fees incurred in respect of a lawsuit against Alnylam and AlCana that was
settled in November 2012.
Cash and Cash Equivalents
At September 30, 2013, there was $36.9 million in cash and cash equivalents as
compared to $46.8 million at December 31, 2012. Subsequent to quarter end,
Tekmira completed a public offering financing of 4,312,500 common shares
priced at US$8.00 for gross proceeds of US$34.5 million. The estimated cost of
the financing, including commissions and professional fees, is $2.4 million
resulting in net estimated proceeds of approximately $33.1 million (US$32.1
Based on assumptions discussed in Tekmira's 2012 Annual Report MD&A guidance,
at that time, it was believed that current funds on hand, plus expected
income, including payments from current licensees, collaborative partners and
the DoD would be sufficient to continue product development into 2015, and
that the cash balance would be greater than $35.0 million at the end of 2013.
Including the net proceeds of Tekmira's recent financing, it is now believed
that funds on hand will be sufficient to last until early 2016, and based on
updated cash projections it is expected that the year-end 2013 cash balance
will be in the range of $65.0 to $70.0 million.
Conference Call Information
Tekmira will hold a conference call and webcast today (Wednesday, November 13,
2013) at 1:30 pm Pacific Time (4:30 pm Eastern Time) to discuss its third
quarter 2013 results and provide a corporate update. A live webcast of the
call can be accessed through the Investor section of Tekmira's website at
www.tekmirapharm.com. Or, alternatively, to dial into the conference call,
please call 914-495-8556 or 1-866-393-1607.
An archived webcast of this conference call will be available on the Tekmira
website approximately two hours after the event. Or alternatively, you may
access a replay of the conference call available until November 16, 2013 by
calling 404-537-3406 or 1-855-859-2056 and referencing conference ID 98545305.
About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a broad number of human diseases
by "silencing" disease causing genes. The discoverers of RNAi, a gene
silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery
technology to be effective systemically. Tekmira believes its LNP technology
represents the most widely adopted delivery technology for the systemic
delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in
multiple clinical trials by both Tekmira and its partners. Tekmira's LNP
technology (formerly referred to as stable nucleic acid-lipid particles or
SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles
that are effective in delivering RNAi therapeutics to disease sites in
numerous preclinical models. Tekmira's LNP formulations are manufactured by a
proprietary method which is robust, scalable and highly reproducible, and
LNP-based products have been reviewed by multiple FDA divisions for use in
clinical trials. LNP formulations comprise several lipid components that can
be adjusted to suit the specific application.
About Alnylam RNAi Technology
Tekmira has licenses to Alnylam RNAi intellectual property for certain siRNA
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on
advancing novel RNAi therapeutics and providing its leading lipid nanoparticle
delivery technology to pharmaceutical partners. Tekmira has been working in
the field of nucleic acid delivery for over a decade and has broad
intellectual property covering LNPs. Further information about Tekmira can be
found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains "forward-looking statements" or "forward-looking
information" within the meaning of applicable securities laws (collectively,
"forward-looking statements"). Forward-looking statements in this news release
include statements about Tekmira's strategy, future operations, clinical
trials, prospects and the plans of management; RNAi (ribonucleic acid
interference) product development programs; the timing and quantum of
milestone and royalty payments to be received under contracts with Tekmira's
partners, including the trigger of a US$5 million milestone payment expected
from Alnylam; statements with respect to revenue and expense fluctuation and
guidance; statements about Tekmira's cash runway and estimated cash and cash
equivalents at the end of 2013; and estimates of the length of time Tekmira's
business will be funded by its anticipated financial resources.
With respect to the forward-looking statements contained in this news release,
Tekmira has made numerous assumptions regarding, among other things: LNP's
status as a leading RNAi delivery technology; Tekmira's research and
development capabilities and resources; and Tekmira's financial position and
its ability to execute on its business strategy. While Tekmira considers these
assumptions to be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social uncertainties
Additionally, there are known and unknown risk factors which could cause
Tekmira's actual results, performance, or achievements to be materially
different from any future results, performance or achievements expressed or
implied by the forward-looking statements contained herein. Known risk factors
include, among others: Tekmira's products may not prove to be effective or as
potent as currently believed; there may be no further advancements in
next-generation LNP technologies; anticipated studies and submissions to the
FDA may not occur as currently anticipated, or at all; the FDA may require
additional pre-clinical, clinical or other studies, refuse to approve
TKM-Ebola, or place restrictions on our ability to commercialize TKM-Ebola;
completion of preclinical work and IND applications may not occur as currently
anticipated, or at all; Tekmira may never identify another product development
candidate; Tekmira may not obtain and protect intellectual property rights,
and operate without infringing on the intellectual property rights of others;
Tekmira may face competition from other pharmaceutical or biotechnology
companies and the possibility that other organizations have made advancements
in RNAi delivery technology that Tekmira is not aware of; anticipated
pre-clinical and clinical trials may be more costly or take longer to complete
than anticipated, and may never be initiated or completed, or may not generate
results that warrant future development of the tested drug candidate; Tekmira
may not receive the necessary regulatory approvals for the clinical
development of Tekmira's products; expected milestone or royalty payments
related to the settlement and licensing agreement between Tekmira and Alnylam
may not be received in the quantum and on the timing currently anticipated, or
at all; Tekmira may lose the arbitration proceedings with Alnylam in
connection with ALN-VSP; the possibility that Tekmira may not enter into a
separate cross license agreement with AlCana on the terms currently
anticipated, or at all; Tekmira's development partners and licensees
conducting clinical trial, development programs and joint venture strategic
alliances may not result in expected results on a timely basis, or at all;
anticipated payments under contracts with Tekmira's collaborative partners may
not be received by Tekmira on a timely basis, or at all, or in the quantum
expected by Tekmira; payments received from third parties may not be
sufficient to fund Tekmira's continued business plan as currently anticipated;
future operating results are uncertain and likely to fluctuate; Tekmira may
not be able to raise additional financing required to fund further research
and development, clinical studies, and obtain regulatory approvals, on
commercially acceptable terms or at all; economic and capital market
conditions; Tekmira may become subject to product liability or other legal
claims for which Tekmira has made no accrual in its financial statements; and,
Tekmira's cash runway and cash position may be substantially less than
projected and may be less than required to continue current operations.
A more complete discussion of the risks and uncertainties facing Tekmira
appears in Tekmira's Annual Report on Form 20-F for the year ended December
31, 2012, which is available at www.sedar.com or at www.sec.gov/edgar.shtml.
All forward-looking statements herein are qualified in their entirety by this
cautionary statement, and Tekmira disclaims any obligation to revise or update
any such forward-looking statements or to publicly announce the result of any
revisions to any of the forward-looking statements contained herein to reflect
future results, events or developments, except as required by law.
Director, Investor Relations
Longview Communications Inc.
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