Threshold Pharmaceuticals Inc.
) reported fourth-quarter 2012 net loss per share of 10 cents,
narrower than the Zacks Consensus Estimate of a loss of 12 cents
and the year-ago loss of 11 cents.
Fourth-quarter revenues were $2 million, compared with $62000
in the year-ago quarter. Revenues missed the Zacks Consensus
Estimate of $3 million.
Full year 2012 net loss per share was $1.31, narrower than the
Zacks Consensus Estimate of a loss of $1.89 and the year-ago loss
of $56 cents. Revenues in 2012 were $5.9 million, compared with
$62000 in 2011. Revenues for 2012 were below the Zacks Consensus
Estimate of $7 million.
In fourth quarter 2012, research and development (R&D)
expenses were $6.2 million, down 7.5% year over year. $3.0
million was received as
) 70% share of funding the development of TH-302. This amount was
partially offset by a rise of $2.5 million in clinical
development and employee related expenses.
In the reported quarter, general and administrative expenses were
$1.9 million, up 35.7% from the year-ago period. The increase was
driven by an increase in employee related expenses and consulting
In Feb 2012, Merck KGaA signed an agreement with Threshold for
global license and co-development of TH-302. TH-302 is in a phase
III study that will evaluate the efficacy and safety of TH-302
Eli Lilly and Company
) Gemzar (gemcitabine) in patients with previously untreated,
locally advanced unresectable or metastatic pancreatic
The study is being conducted under the US Food and Drug
Administration's (FDA) Special Protocol Assessment (SPA) program.
The randomized, double-blind, placebo controlled, international
and multi-center study will enroll roughly 660 patients and will
compare TH-302 plus Gemzar with placebo plus Gemzar. The study's
primary endpoint is overall survival and the secondary endpoints
include efficacy measured by progression-free survival (PFS),
overall response rate and disease control rate.
Another phase III trial is being conducted with TH-302 also
under the FDA's SPA program. The 406 trial will compare TH-302 in
combination with doxorubicin to doxorubicin alone for treating
patients with soft tissue sarcoma (STS). Merck KGaA has orphan
drug status in the US as well as the European Union for TH-302
for the STS indication. Enrollment is expected to be completed
roughly at the end of 2013.
The successful development of TH-302 will be a major milestone
for Threshold Pharma, which currently does not have any marketed
products in its portfolio. Threshold Pharma carries a Zacks Rank
#3 (Hold). Right now,
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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