EWING, N.J., March 17, 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 fourth quarter and year ended December 31, 2014.
“In 2014, Celator continued to meet important milestones as we look to leverage our CombiPlex® platform to introduce a new medical standard for combining cancer therapies,” said Scott Jackson, chief executive officer of Celator. “CPX-351, our lead product candidate, completed enrollment of the pivotal Phase 3 study in patients with secondary acute myeloid leukemia (sAML). In addition, we have embarked on a broader clinical development program via several investigator-initiated studies evaluating CPX-351 in other AML patient populations as well as other blood cancers. We are also excited with the CombiPlex technology platform work underway on novel combinations involving targeted therapies or epigenetic modulators. With a number of near-term milestones and cash that gets us well beyond the release of our Phase 3 study’s primary endpoint data, overall survival, I believe this is a very exciting time for the company.”
The following are expected milestones for the company:
CPX-351 Phase 3 study:
- 2Q 2015 Induction response rate
- 1Q 2016 Overall survival data
Technology platform:
- 3Q 2015 information packages (formulation and preclinical data) for novel combinations
Fourth Quarter 2014 and Recent Business Highlights:
CPX-351:
- In January, Celator announced that 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.
- In December, Celator announced the independent Data and Safety Monitoring Board for the Phase 3 clinical study of CPX-351 conducted a pre-planned analysis of the first 225 patients randomized to the study and recommended that the study continue as planned without any study modifications.
- In December, data were presented on CPX-351 at the American Society of Hematology meeting. Most notable were data presented from preclinical studies examining the tissue distribution, metabolism and excretion characteristics of cytarabine and daunorubicin administered as CPX-351 compared to the non-liposomal forms of the same drugs. The results demonstrated CPX-351 liposomes directed drug away from most normal tissues and are consistent with an improved safety profile. Importantly, CPX-351 accumulated and persisted in the bone marrow for over four days at cytarabine and daunorubicin concentrations known to exert anti-leukemic activity against AML blasts.
- In October, the company announced the target enrollment, of 300 patients, for the Phase 3 study was achieved ahead of schedule. The study stopped enrolling patients in November and a total of 309 patients were randomized.
General business:
- Earlier this month, Celator expanded its Board of Directors with the addition of Jean-Pierre Bizzari, M.D. Dr. Bizzari has served as Executive Vice-President, Group Head, Clinical Oncology Development at Celgene Corporation since joining Celgene in 2008. Under his leadership, Celgene achieved numerous successes, including the development and approval of several leading products in the hematology oncology area.
- In December, Celator received approximately $1.9 million in non-dilutive financing through New Jersey’s Technology Business Tax Certificate Transfer Program. This program enables qualifying companies to turn their tax losses and credits into cash.
- In December, Celator announced receipt of European patent allowance on its nanoparticle delivery system. This should help establish the broad applicability of the CombiPlex platform in the development of combination cancer therapies. This patent provides protection until November 2028.
- In October, Celator announced the closing of an underwritten public offering of 7,602,823 shares of common stock and warrants at a price of $1.95 per unit. Celator received net proceeds of over $13.6 million.
- In October, with Celator achieving its target enrollment in the CPX-351 Phase 3 study before year-end, the interest-only period of the Hercules Technology Growth Capital, Inc. term loan was extended six months to December 1, 2015, and the term loan maturity date was extended six months to June 1, 2018.
Financial Highlights:
- Cash Position: Cash and cash equivalents as of December 31, 2014 were $32.4 million, compared to $23.6 million as of December 31, 2013. The net increase of $8.8 million was due to the October 2014 public offering, which raised approximately $13.6 million and the May 2014 term loan funding, which provided $9.6 million at closing. This was offset by cash used in operating activities of approximately $14.4 million. Management believes that the cash and cash equivalents at December 31, 2014, and the additional $5.0 million cash available to Celator through the Hercules Technology Growth Capital term loan 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 December 31, 2014 from $3.4 million for the same period in 2013. For the year ended December 31, 2014 research and development expenses increased to $11.9 million from $9.4 million for the same period in 2013. The full year increase in R&D expenses was largely due to an increase in clinical and regulatory activities during the year related to the Phase 3 study of CPX-351 and technology advancement of the CombiPlex platform.
- G&A Expenses: General and administrative expenses increased to $1.8 million and $7.3 million for the three months and year ended December 31, 2014, respectively, from $1.5 million and $5.4 million for the same periods in 2013. The increase was primarily attributable to increases in commercial operations expense, compensation and stock option expense.
- Net Loss: Net loss was $2.4 million and $16.9 million for the three months and year ended December 31, 2014, respectively, as compared to $3.4 million and $20.8 million for the same periods in 2013.
Conference Call Information:
Celator will host a conference call and live audio webcast today at 4:30 p.m. ET to discuss the fourth quarter and year-end 2014 financial results. To participate in the conference call, please dial (877) 303-6316 (domestic) or (650) 521-5176 (international) and refer to conference ID 5450927. 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 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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