KaloBios Pharmaceuticals, Inc.
) reported a net loss per share of 49 cents in second quarter
2013, wider than the Zacks Consensus Estimate of a loss of 41
cents, but narrower than the year-ago loss of $1.01.
Revenues for the quarter were approximately $15,000 as
compared to $3 million in the year-ago quarter. Revenues
consisted entirely of contract revenues. Contract revenues
declined as research support activities related to the company's
) were completed.
Research and development (R&D) expenses were $9.6 million,
above the year-ago expenses of $4.2 million. General and
administrative expenses were $1.9 million, above the year-ago
expenses of $0.9 million.
KaloBios is enrolling patients in a phase II study on its
anti-GM-CSF mAb candidate, KB003, for the treatment of severe
asthma. KaloBios anticipates top-line results in the first
quarter of 2014.
The company is currently conducting a phase II study on its
anti-PcrV mAb fragment, KB001-A, in cystic fibrosis (CF) patients
for the prevention and treatment of chronic pseudomonas
aeruginosa (Pa). For this, KaloBios received orphan drug status
in the EU while the U.S. Food and Drug Administration (FDA) has
completed its review and has asked for additional information.
After the completion of the ongoing phase II CF study, KaloBios
will provide the FDA with additional data. Enrollment is expected
to complete in mid 2014. Top-line results from the KB001-A study
are expected in the fourth quarter of 2014.
The FDA has granted Fast Track designation to KB001-A to
KaloBios' partner, Sanofi, for the prevention of bacterial
pneumonia caused by Pa in mechanically ventilated patients. This
study is undertaken by Sanofi.
KaloBios is currently conducting a phase I study on its
anti-EphA3 mAb, KB004, for the treatment of hematologic
malignancies. After top-line data from this study is obtained (in
the fourth quarter of 2013), KaloBios plans to start the phase II
expansion phase of the study in acute myeloid leukemia (AML) and
myelodysplastic syndrome (MDS).
The stock carries a Zacks Rank #3 (Hold). Currently, companies
Questcor Pharmaceuticals Inc.
) look well positioned with a Zacks Rank #1 (Strong Buy).
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