Celator® Pharmaceuticals Announces Business Update And Third Quarter 2014 Financial Results

EWING, N.J., Nov. 13, 2014 /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 third quarter ended September 30, 2014.

"We made important progress in the third quarter, particularly in advancing our lead Phase 3 study of CPX-351 in secondary AML. We achieved our target enrollment in the study (300 patients), ahead of schedule, and we remain on track to report initial data on induction response rate, a secondary endpoint, in the second quarter of 2015 and overall survival data, the primary endpoint, in the first quarter of 2016," said Scott Jackson, Chief Executive Officer of Celator. "We also raised over $13.5 million in net proceeds from our October public offering, which we expect will fund the company beyond the primary endpoint data and into the second half of 2016. The proceeds will also support extending the application of our proprietary CombiPlex® platform by investigating novel combinations of molecularly targeted therapies. Combination therapies, which we believe will remain a cornerstone in the future of cancer treatment, are an important part of our long-term development strategy and our goal of developing advanced products to change the way physicians currently treat cancer."

Third Quarter 2014 and Recent Business Highlights:

CPX-351:

• In October, Celator announced it had achieved its target enrollment in a Phase 3 clinical study of CPX-351 Liposome for Injection in patients with high-risk (secondary) acute myeloid leukemia (AML).
• In September, Celator announced the publication of preclinical data in Pediatric Blood & Cancer that further characterize the therapeutic potential of CPX-351 and support its ongoing clinical testing in pediatric patients with acute lymphoblastic leukemia (ALL).
• In August, Celator announced the initiation of a Phase 2 pharmacokinetic and pharmacodynamics study evaluating the effects of CPX-351 on cardiac repolarization in adult patients with hematologic malignancies.  This study is being conducted to support the U.S. Food and Drug Administration (FDA) requirements for submission of a New Drug Application (NDA) for CPX-351.
• In July, Celator held its first Analyst Day meeting.  The two areas of focus were the CombiPlex technology platform, and the development and commercialization of CPX-351. 
  • Regarding CombiPlex, Celator announced that it is evaluating three novel combinations:
    • Combinations targeting signaling pathways associated with major cancer indications:
      • Inhibitors of PI3K/AKT/mTOR pathways in combination with
      • Inhibitors of Ras/Raf/MEK/ERK pathways
    • Combinations of existing chemotherapies with molecularly targeted agents:
      • Active cytotoxics, such as taxanes, in combination with
      • Cellular response modulators that control apoptosis
    • Combinations of epigenetic modulators:
      • Histone deacetylase inhibitors in combination with
      • Hypomethylating agents
  • With regard to CPX-351, Celator provided an update on the ongoing Phase 3 study and parallel development exploring the potential of CPX-351 in other AML patient populations as well as other hematologic malignancies, and announced plans to commercialize CPX-351 in the U.S. and partner ex-U.S.

Corporate:

• 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. The Company received net proceeds of over $13.5 million. Management believes that the cash and cash equivalents at September 30, 2014, cash available to the Company through the Hercules Technology Growth Capital term loan and the funds received from this offering will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016, past the overall survival analysis for its CPX-351 Phase 3 clinical study. 
• In October, the Company achieved its target enrollment in the CPX-351 Phase 3 study resulting in the interest-only period of the Hercules Technology Growth Capital, Inc. term loan being extended six months to December 1, 2015, and the term loan maturity date being extended from December 1, 2017 to June 1, 2018.
• In September, Celator announced the appointment of Michael R. Dougherty as Chairman of the Board of Directors.

Financial Highlights:

• Cash Position: Cash and cash equivalents as of September 30, 2014 were $20.2 million, which excludes the $13.5 million raised in October 2014, compared to $24.9 million as of June 30, 2014.
• R&D Expenses: Research and development expenses increased to $3.3 million for the three months ended September 30, 2014, from $2.3 million for the same period in 2013. The increase in R&D expenses was largely due to manufacturing, clinical and regulatory activities related to the Phase 3 study of CPX-351, and an increase in compensation and stock option expenses.
• G&A Expenses: General and administrative expenses increased to $1.9 million for the three months ended September 30, 2014, from $1.4 million for the same period in 2013. The increase was primarily attributable to costs associated with commercial and strategic planning, investor relations and professional fees, and an increase in compensation and stock option expenses. These increases were partially offset by a reduction in public company-related expenses.
• Operating Loss: Net loss was $5.5 million for the three months ended September 30, 2014, compared to $3.7 million for the same period in 2013.

Conference Call Information:

Celator will host a conference call and live audio webcast today at 4:30 p.m. ET to report third quarter 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 30975600. The live webcast of the call can be accessed in the Investors section of the company's website at www.celatorpharma.com. An archived webcast will be available on the company'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 until exposure to the tumor following administration. The company 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; and several programs exploring novel combinations of existing drugs, including molecularly targeted therapies.

For more information, please visit the company'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," "believe," "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 preclinical and clinical development programs, availability of data and other future results, working capital requirements, 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. 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 the company in general, see Celator's Form 10-K for the year ended December 31, 2013 and other filings by the company with the U.S. Securities and Exchange Commission.

SOURCE Celator Pharmaceuticals, Inc.

Related Links

http://www.celatorpharma.com