EWING, N.J., May 7, 2015 /PRNewswire/ -- 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, today reported business highlights and financial results for the first quarter ended March 31, 2015.
“This is a very exciting time for Celator as we continue to meet important milestones and look to leverage our CombiPlex® platform to introduce a new medical standard for combining cancer therapies,” said Scott Jackson, chief executive officer of Celator. “At the end of this quarter, we plan to report induction response rate data (secondary endpoint) in the Phase 3 study of CPX-351. We also remain on track with our broader clinical development program via several investigator-initiated studies evaluating CPX-351 in other AML patient populations, as well as other blood cancers. As previously stated, in the third quarter of 2015 we expect information packages for the CombiPlex technology platform studies, which are underway with novel combinations involving targeted therapies or epigenetic modulators.” Mr. Jackson continued, “Taking into account the many near term milestones, coupled with our favorable cash position, which takes us well beyond the expected release of the Phase 3 study’s overall survival data (primary endpoint), we are excited about our future.”
First Quarter 2015 and Recent Business Highlights:
CPX-351:
- In April, data were presented for CPX-351 at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia, PA. These presentations described the effects of combining CPX-351 with existing chemotherapies used to treat AML and other blood cancers as well as, for the first time, with novel molecularly targeted agents that have demonstrated activity in clinical trials. In both cases, the combined agents complemented each other’s anti-leukemic properties, resulting in an enhanced overall effect.
- In January, the U.S. Food and Drug Administration granted Fast Track designation for CPX-351 for the treatment of elderly patients with secondary AML.
- In January, Celator reported the Phase 2 study of CPX-351 in patients with AML in first relapse was published in Cancer, a peer-reviewed journal of the American Cancer Society.
General business:
- On March 30, Celator drew down the remaining $5.0 million of the Hercules Technology Growth Capital (Hercules) $15.0 million term loan.
- In March, Lawrence Mayer, Ph.D., founder, president and chief scientific officer of Celator, was inducted to the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows. Dr. Mayer was nominated, reviewed and elected by peers and members of the College of Fellows, which is comprised of the top two percent of medical and biological engineers in the country. AIMBE Fellows are regularly recognized for their contributions in teaching, research and innovation.
- In March, we announced the appointment of Jean-Pierre Bizzari, M.D. to Celator’s Board of Directors. Under Dr. Bizzari’s leadership, Celgene achieved numerous successes, including the development and approval of several leading oncology products, such as REVLIMID® (lenalidomide), VIDAZA® (azacitidine), ISTODAX® (romidepsin), and ABRAXANE® (nab-paclitaxel).
Financial Highlights:
- Cash Position: Cash and cash equivalents as of March 31, 2015 were $32.9 million, compared to $32.4 million as of December 31, 2014. The net increase of $0.5 million was due to $5.0 million in proceeds from the final draw down of the Hercules Technology Growth Capital loan. This was offset by cash used in operating activities of approximately $4.5 million. Management believes that the cash and cash equivalents at March 31, 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 decreased to $2.7 million for the three months ended March 31, 2015 from $3.0 million for the same period in 2014. The decrease in R&D expenses was largely due to lower manufacturing costs and the elimination of costs associated with a metabolism study that began during the second half of 2013 for CPX-351 and ended in 2014. These decreases were offset by increases in outsourced clinical trial and regulatory activities related to CPX-351.
- G&A Expenses: General and administrative expenses decreased to $1.8 million for the three months ended March 31, 2015, from $1.9 million for the same period in 2014. The decrease was primarily attributable to a decrease in professional fees and franchise taxes. These decreases were offset by increases in compensation and stock option expenses.
- Net Loss: Net loss was $4.7 million for the three months ended March 31, 2015, as compared to $4.3 million for the same period in 2014.The increase was primarily due to a $0.5 million reduction in funding from the Leukemia & Lymphoma Society and $0.2 million in interest expense related to the Hercules loan.
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 of 2015 financial results. To participate in the conference call, please dial (877) 303-6316 (domestic) or (650) 521-5176 (international) and refer to conference ID 37489100. 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.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a clinical stage 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 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 ensure its exposure to the tumor. Celator’s pipeline includes lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product candidate, CPX-8 (a hydrophobic docetaxel prodrug nanoparticle formulation), being studied by the National Cancer Institute’s Nanotechnology Characterization Laboratory. The company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies and epigenetic modulators.
For more information, please visit Celator’s website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
Forward-Looking Statements:
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 and therapeutic potential of CPX-351, the availability and timing of release of data from clinical studies, our expectations regarding our research and development programs, expanding our pipeline and advancing our CombiPlex platform, 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 conduct of future clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies and other matters that could affect the commercial potential of our drug candidates, our ability to raise capital and the trading of our common stock. Celator undertakes no obligation to update or revise any forward-looking statements.
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