“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.
Conference Call Information:
Celator will host a conference call and live audio webcast today at 4:30 p.m. ET to provide a business update and discuss the first quarter 2016 financial results. To participate in the conference call, please dial (877) 303-6316 (domestic) or (650) 521-5176 (international) and refer to conference ID 5850159. The live webcast of the call can be accessed in the Investors section of Celator’s website at www.celatorpharma.com. An archived webcast will be available on Celator’s website beginning approximately two hours after the event.
VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ration. VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. VYXEOS was granted orphan drug status for the treatment of acute myeloid leukemia (AML) by the FDA and the European Commission. VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.
In a Phase 3 trial in patients with high-risk (secondary) AML, the median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3, representing a 3.61-month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm. Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS. No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.
Celator published results from two randomized, controlled, Phase 2 trials with VYXEOS. The first trial was conducted in newly diagnosed elderly AML patients and the second trial was conducted in patients with AML in first relapse.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor. Celator’s lead product is VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin completed a Phase 3 trial for the treatment of acute myeloid leukemia. Celator has also conducted clinical development on CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer; and have a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation. More recently, the company has advanced its CombiPlex platform and broadened its application to include molecularly targeted therapies. For more information, please visit Celator’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding the safety, potential efficacy, therapeutic potential, our expectations regarding the timing of our regulatory filings and the timing of regulatory approvals, and commercial potential of VYXEOS, our expectations regarding our research and development programs, expanding our pipeline and advancing our CombiPlex platform, our ability to pursue R&D collaborations with pharmaceutical companies and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, working capital, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the regulatory process, whether the final results of our clinical studies will be supportive of regulatory approval to market VYXEOS and other matters that could affect the commercial potential of our drug candidates, the uncertainties inherent in the conduct of future clinical studies, enrollment in clinical studies, whether clinical trial results obtained to date will be predictive of future results, our ability to raise capital and the trading of our common stock. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Celator in general, see Celator’s Form 10-K for the year ended December 31, 2015 and other filings by Celator with the U.S. Securities and Exchange Commission.
Sam Brown, Inc.
Mike Beyer, 312-961-2502
The Trout Group
Peter Rahmer, 646-378-2973
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