SOUTH SAN FRANCISCO, Calif., Aug. 7, 2014 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today provided an update on its current clinical programs and announced financial results for the second quarter of 2014.
Development Program Updates
KaloBios completed enrollment in July in the open-label Phase 1 dose escalation study of KB004 in hematologic malignancies. This study has enrolled a total of 50 patients in the Phase 1 portion of the study, including patients with myelodysplastic syndrome (MDS), myelofibrosis (MF) and acute myeloid leukemia (AML), with 80% of patients enrolled being late-stage AML patients. The drug continues to be well tolerated with the most commonly reported side effects being first-dose infusion reactions. No maximum tolerated dose (MTD) was reached in this study. Based on the outcome of the Phase 1 portion of the study, KaloBios has declared 250mg as the high dose for purposes of the Phase 2 expansion portion of the study.
The Phase 2 expansion portion of the study will be enrolling patients with hematologic malignancies that are pre-screened to be EphA3 positive. Now that the high-dose has been declared, KaloBios will seek to enroll one high-dose cohort of 10 MDS patients, a second high-dose cohort of 10 AML patients, and a third high-dose cohort comprised of 10 MF patients.
In July, KaloBios announced that target enrollment in the Phase 2 study in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (Pa) lung infections was achieved with the enrollment of the 180th patient. KaloBios expects to release top-line data on this study early in the first quarter of 2015.
KaloBios also at that time announced that it had regained full global rights to KB001-A in all indications as a result of the execution of a negotiated termination of the company's collaboration agreement with Sanofi Pasteur. KaloBios has stated that it intends to seek a partner with a focus on infectious disease, hospital pharmaceuticals, or cystic fibrosis who can accelerate and financially support the future development of KB001-A.
"We are very excited about the recent progress we have made on our programs," said Nestor A. Molfino, MD, MSc, Chief Medical Officer of KaloBios. "Completing enrollment in our Phase 2 KB001-A study in CF patients in a timeframe that will potentially allow us to report out top-line data in early 2015 was a major achievement for the company. At the same time, completing enrollment in the KB004 Phase 1 dose escalation study sets the stage for us to initiate enrollment in the high-dose cohorts in the Phase 2 efficacy-seeking portion of our KB004 study in the second half of 2014."
Key Anticipated Milestones for 2014-2015
Full enrollment of the KB001-A CF Phase 2 study (completed in July 2014)
Completion of enrollment in at least one indication in the Phase 2 expansion portion of our KB004 study in hematologic malignancies
Top line KB001-A CF Phase 2 study results
Second Quarter 2014 Financial Results
Net loss for the three months ended June 30, 2014 was $9.8 million or $0.30 per common share, as compared to $11.8 million or $0.49 per common share for the same period in 2013.
No contract revenue was reported for the second quarter of 2014 as compared to $15,000 reported in the same period in 2013. The decrease in contract revenues was due to the completion of all substantive performance obligations related to research support activities under our agreement with Sanofi Pasteur.
Research and development (R&D) expenses were $6.7 million for the three months ended June 30, 2014 as compared to $9.6 million for the same period in 2013. The decrease in R&D expense was primarily due to decreased clinical trial activity compared with the prior period largely as a result of the completion of the KB003 Phase 2 study in patients with severe asthma in the first quarter of 2014. General and administrative (G&A) expenses were $2.8 million for the second quarter of 2014 compared to $1.9 million for the same period in 2013. The increase in G&A expenses was due primarily to costs incurred in our move into a new facility in the second quarter of 2014 as well as higher legal, accounting and consulting costs associated with becoming a public reporting company.
As of June 30, 2014, KaloBios had cash, cash equivalents and investments totaling $59.2 million, compared to $76.7 million at December 31, 2013.
KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies designed to treat severe life-threatening or debilitating diseases for which there is an unmet medical need, with a clinical focus on severe respiratory diseases and cancer.
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