Celator Pharmaceuticals (CPXX) Posts Q3 Loss of 21c/Share

Celator Pharmaceuticals (NASDAQ: CPXX) reported Q3 EPS of ($0.21), $0.04 better than the analyst estimate of ($0.25).

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.

For earnings history and earnings-related data on Celator Pharmaceuticals (CPXX) click here.

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