On November 12, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported business highlights and financial results for the third quarter ended September 30, 2015 (Press release, Celator Pharmaceuticals, NOV 12, 2015, View Source [SID:1234508214]).
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"The momentum builds as we continue to deliver on our milestones, from the induction response rate improvement observed in our Phase 3 study with VYXEOS (formerly CPX-351) and announced last quarter, to impressive results from data packages on novel combination programs," said Scott Jackson, Chief Executive Officer of the Company. "The external validation of our proprietary technologies, as evidenced with VYXEOS being selected as the Nanomedicine Product of the Year is very exciting. We expect the overall survival data from the Phase 3 study in the first quarter of 2016."
Third Quarter 2015 and Recent Highlights:
Celator will receive more than $1.675 million from the sale of its net operating losses and research and development credits under the New Jersey Technology Business Tax Certificate Transfer Program. The Company expects to receive this amount by the end of 2015.
Pre-clinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrated the broad applicability of Celator’s hydrophobic prodrug nanoparticle (HPN) delivery technology to molecularly targeted agents, including inhibitors of MEK, Akt, HSP90 and B-Raf. Significant efficacy improvements for HPN co-formulated combinations over conventional administration of targeted agent regimens were reported.
VYXEOS (formerly CPX-351) was selected the Best Nanomedicine Product of the Year by a panel of pharmaceutical industry specialists that recognizes innovative product developments in nanomedicine.
Celator announced top-line results from an intensive QT/QTc study showing VYXEOS has no QT/QTc interval prolongation and that additional data will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. This study was conducted to support the New Drug Application for VYXEOS which the Company plans to file in the third quarter of 2016.
The Independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase 3 clinical study with VYXEOS has completed the final pre-planned safety review of all patients and has again recommended the study continue as planned without any modifications.
Patients began enrolling in an investigator-initiated Phase 2 clinical study evaluating VYXEOS as a treatment for patients with newly diagnosed acute myeloid leukemia (AML) at high risk for induction treatment mortality.
Celator’s senior management team hosted an Analyst and Investor Day to discuss the company’s growth strategy, its lead product candidate, VYXEOS, and its proprietary CombiPlex technology platform.
Michael R. Dougherty was appointed Executive Chairman of the Board of Directors. Mr. Dougherty has been a director of Celator since July 2013 and served as Chairman since September 2014.
Financial Highlights:
Cash Position: Cash and cash equivalents as of September 30, 2015 were $24.1 million, compared to $32.4 million as of December 31, 2014. The decrease was primarily due to $13.3 million of net cash used in operating activities, partially offset by $5.0 million in proceeds from the final draw down of the Hercules Technology Growth Capital loan. Cash and cash equivalents as of June 30, 2015 were $28.5 million. Management believes that the cash and cash equivalents at September 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016.
R&D Expenses: Research and development expenses were $2.9 million and $9.0 million for the three and nine months ended September 30, 2015, as compared to $3.3 million and $9.2 million for the same periods in 2014. The decrease in R&D expenses in the comparable three-month and nine-month periods were primarily due to decreases in regulatory and clinical trial costs related to the Phase 3 study of VYXEOS and manufacturing and drug costs.
G&A Expenses: General and administrative expenses were $1.9 million and $5.7 million for the three and nine months ended September 30, 2015, as compared to $1.9 million and $5.5 million for the same periods of 2014. The increase in the comparable nine-month period was primarily attributable to increases in compensation, public company expenses and professional fees offset by reductions in consulting and recruiting fees.
Net Loss: Net loss was $5.2 million and $14.9 million for the three and nine months ended September 30, 2015, as compared to $5.5 million and $14.5 million for the same periods in 2014.