On March 21, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, reported business highlights and financial results for the fourth quarter and year ended December 31, 2015 (Press release, Celator Pharmaceuticals, MAR 21, 2016, View Source [SID:1234509765]).
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"In 2015, Celator continued to meet important milestones with VYXEOS and the CombiPlex platform," said Scott Jackson, chief executive officer of Celator. "Recently, we announced positive results from our Phase 3 trial in patients with high-risk (secondary) acute myeloid leukemia (AML), comparing VYXEOS to the long established standard of care, known as 7+3. We submitted results from the Phase 3 trial to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting. Based on these results, we expect to submit a New Drug Application to the FDA in the third quarter of this year. In addition, in 2015 we embarked on a broader clinical development program via several trials evaluating VYXEOS in other AML patient populations as well as other blood cancers. Lastly, we were pleased to report data from novel combinations involving targeted therapies based on our CombiPlex technology platform. This is a very exciting and transformational time for Celator."
The following are expected milestones for VYXEOS:
3Q 2016 – New Drug Application (NDA) submission
1Q 2017 – Marketing Authorization Application (MAA) submission
Mid-2017 – Prescription Drug User Fee Act (PDUFA) date (assuming FDA priority review)
1Q 2018 – Committee for Medicinal Products for Human Use (CHMP) opinion date
Recent Business and Fourth Quarter 2015 Highlights
VYXEOS (CPX-351)
In March, Celator announced that the Phase 3 trial for VYXEOS in patients with high-risk (secondary) acute myeloid leukemia demonstrated a statistically significant improvement in overall survival.
In January, Celator announced participation in a Cardiff University clinical trial in patients with AML or High-Risk Myelodysplastic Syndrome (HR-MDS).
In December, data were presented on VYXEOS at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. Most notable were data presented showing VYXEOS did not prolong the QT/QTc interval, a positive safety outcome. The drugs remain encapsulated in the nano-scale delivery vehicle while circulating in the plasma ( > 97% over the first 24 hours), which allows the drugs to be delivered directly to leukemia cells at the synergistic 5:1 molar ratio. The trial included patients with newly diagnosed AML, relapsed/refractory AML and relapsed/refractory ALL. Responses were seen in each of the three acute leukemia patient populations.
Also in December at the ASH (Free ASH Whitepaper) meeting we presented data on health resource utilization (HRU) assessments from our previously published randomized Phase 2 trial comparing first-line treatment with VYXEOS to the 7+3 regimen, in newly diagnosed older patients (age 60-75) with AML. A number of outcomes (such as fewer inductions to respond, more patients receiving consolidation on an outpatient basis, improvement in the ratio of median event-free survival days to median hospital days) were favorable for VYXEOS compared to 7+3.
In October, VYXEOS was recognized with the Nanomedicine Award 2015. This award recognizes projects or products that have been developed using innovative solutions based on nanotechnology.
Technology Platform
In October, positive results were presented from our CombiPlex technology platform applied to drug combinations incorporating molecularly targeted agents (MTAs) 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). The successful application of this technology to molecularly targeted agents across a wide range of drug classes makes a compelling data package that we believe will be instrumental in pursuing R&D collaborations with pharmaceutical companies.
General Business
In November, Celator announced it was approved to sell $1.8 million of its net operating losses and unused research and development (R&D) credits under the New Jersey Technology Business Tax Certificate Transfer Program for the year 2015, for which the company received $1.7 million in non-dilutive financing.
In November, Celator announced a notice of allowance of claims by the United States Patent and Trademark Office for the patent "Compositions for Delivery of Drug Combinations." This patent covers the Company’s proprietary CombiPlex technology, and the allowed claims increase the scope of drug delivery vehicles covered by the patent.
Financial Highlights
Cash Position: Cash and cash equivalents as of December 31, 2015 were $23.3 million, compared to $32.4 million as of December 31, 2014. During the first quarter of 2016, the Company sold 1,353,900 shares of common stock through an at-the-market (ATM) equity offering program for net proceeds of $9.8 million. Management believes that the cash and cash equivalents at December 31, 2015, and the cash generated to date from sales under the ATM will be sufficient to meet estimated working capital requirements and fund planned operations into the second quarter of 2017.
R&D Expenses: Research and development expenses increased to $2.8 million for the three months ended December 31, 2015 from $2.7 million for the same period in 2014. For the year ended December 31, 2015 research and development expenses decreased to $11.8 million from $11.9 million for the same period in 2014. The full year decrease in R&D expenses was largely due to a decrease in clinical and regulatory activities during the year related to the Phase 3 trial of VYXEOS as the trial was fully enrolled, offset by an increase in expenses relating to our work on the CombiPlex platform.
G&A Expenses: General and administrative expenses increased to $1.9 million for the three months ended December 31, 2015 from $1.8 million for the same period in 2014. For the year ended December 31, 2015 general and administrative expenses increased to $7.7 million from $7.3 million for the same period in 2014. The increase was primarily attributable to increases in compensation and stock option expense, investor relations and consulting.
Net Loss: Net loss increased to $4.4 million for the three months ended December 31, 2015 from $2.4 million for same period in 2014. For the year ended December 31, 2015 net loss increased to $19.3 million from $16.9 million for the same period in 2014. The increase in net loss was primarily attributable to increased interest expense and a reduction in income tax benefit.