Celator Pharmaceuticals Inc (NASDAQ:CPXX) reported business highlights and financial results for the first quarter ended March 31, 2016.
“The first quarter of 2016 was transformative for Celator,” said Scott Jackson, chief executive officer of Celator. “Our Phase 3 trial of VYXEOS™ demonstrated a statistically significant improvement in overall survival, among other benefits, in patients with high-risk acute myeloid leukemia (AML) and we plan to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) by the end of the third quarter of this year. We look forward to presenting additional data at the American Society of Clinical Oncology (ASCO) annual meeting next month. In addition, following the positive Phase 3 results, we raised capital that we believe is sufficient to fund planned operations into 2018.”
Celator anticipates achieving the following key objectives:
- Continue to execute on the VYXEOS commercial readiness in the United States;
- Submit the New Drug Application (NDA) for VYXEOS by the end of Q3 2016;
- Continue to expand the clinical development of VYXEOS via investigator-initiated studies, oncology cooperative groups and company-sponsored studies;
- Prescription Drug User Fee Act (PDUFA) date (assuming FDA grants priority review) by mid-2017; and
- United States commercial launch (assuming FDA approval in mid-2017) in Q3 2017.
Recent Business and First Quarter 2016 Highlights
- April – Celator announced that a late-breaking abstract was submitted to ASCO and accepted for an oral presentation on June 4, 2016 at 3:00 pm CT and will be presented by Dr. Jeffrey Lancet from H. Lee Moffitt Cancer Center & Research Institute.
- March – Celator announced that Phase 3 trial data for VYXEOS in patients with high-risk AML demonstrated a statistically significant improvement in overall survival and induction response rate and meaningfully lower 60-day mortality. There was no substantial difference in Grade 3-5 adverse events between VYXEOS and the control arm (7+3 regimen). The company plans to submit an NDA for VYXEOS by the end of the third quarter.
- March – Celator completed an underwritten public offering of 4,600,000 shares of the company’s common stock, resulting in net proceeds of approximately $40.6 million.
- Cash Position: Cash and cash equivalents as of March 31, 2016 were $67.5 million, compared to $23.3 million as of December 31, 2015. The increase was primarily due to the underwritten public offering that netted approximately $40.6 million during the first quarter of 2016 and $9.8 million in net proceeds from the issuance of common stock through an at-the-market equity offering program. Management believes that the cash and cash equivalents at March 31, 2016 will be sufficient to meet estimated working capital requirements and fund planned operations into 2018.
- R&D Expenses: Research and development expenses were $2.7 million for the three months ended March 31, 2016 consistent with the same period in 2015.
- G&A Expenses: General and administrative expenses were $2.5 million for the three months ended March 31, 2016, as compared to $1.8 million for the same period of 2015. The increase was primarily attributable to increases in compensation, pre-launch commercial activities, public company expenses and professional fees.
- Net Loss: Net loss increased to $5.5 million for the three months ended March 31, 2016, from $4.7 million for the same period in 2015. (Original Source)
Shares of Celator closed today at $13.11, down $0.41 or -3.03%. CPXX has a 1-year high of $17.40 and a 1-year low of $1.12. The stock’s 50-day moving average is $13.41 and its 200-day moving average is $4.89.
On the ratings front, Celator has been the subject of a number of recent research reports. In a report issued on April 18, Roth Capital analyst Joseph Pantginis maintained a Buy rating on CPXX, with a price target of $22, which implies an upside of 60.1% from current levels. Separately, on April 11, Needham’s Chad Messer initiated coverage with a Buy rating on the stock and has a price target of $24.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Chad Messer have a total average return of -3.7% and -12.8% respectively. Pantginis has a success rate of 35.3% and is ranked #3663 out of 3828 analysts, while Messer has a success rate of 31.7% and is ranked #3744.
Celator Pharmaceuticals, Inc. is a clinical-stage company, which engages in the research and development of biopharmaceutical products. It intends to provide chemotherapies and molecularly targeted agents to deliver anti-cancer activity and enhance treatment outcomes for cancer patients. It operates under the CombiPlex platform. Its products include VYXEOS, CPX-1, and CPX-8. The company was founded by Lawrence David Mayer and Marcel B. Bally in 1999 and is headquartered in Ewing, NJ.