EWING, N.J., Oct. 28, 2014 (GLOBE NEWSWIRE) -- 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 announced the closing of an underwritten public offering of 7,602,823 shares of common stock and warrants to purchase up to 760,282 shares of its common stock, including the exercise in full of the underwriters' over-allotment option to purchase up to an additional 991,673 units. The shares of common stock and warrants were offered in units consisting of one share of common stock and a warrant to purchase 0.10 of a share of common stock at a price of $1.95 per unit. The shares of common stock and the warrants are immediately separable and were issued separately. The warrants have an exercise price of $3.58 per whole share and have a term of five years. The net proceeds to Celator, after underwriting discounts and commissions and estimated offering expenses, were approximately $13.5 million.
Based on current projections, Celator believes it now has sufficient capital to fund its activities into the second half of 2016.
Celator intends to use the net proceeds from the offering for general corporate purposes including the advancement of the Celator's lead product candidate, CPX-351 (cytarabine:daunorubicin) Liposome for Injection, currently in a Phase 3 clinical study in patients with high risk (secondary) acute myeloid leukemia (AML); ongoing research with drug combinations involving molecularly targeted therapies using its proprietary technology platforms; manufacturing expenses; and general and administrative expenses.
Celator announced yesterday that it achieved the target enrollment, of 300 patients, in its Phase 3 study of CPX-351. This Phase 3 study is a multicenter, randomized, open-label study testing CPX-351 versus the current standard of care, conventional cytarabine and daunorubicin therapy (7+3) in patients with untreated high-risk (secondary) AML.
In addition, Celator expects the following milestones related to its Phase 3 clinical study:
Q4 2014 – Data and Safety and Monitoring Board pre-planned analysis of the first 225 randomized patients with a minimum of 60 days follow-up
Q2 2015 – Analysis of the induction response rate (CR+CRi), a secondary endpoint of the study
Q1 2016 – Analysis of overall survival, the primary endpoint of the study
Celator expects to present information on CPX-351 at the upcoming American Society of Hematology (ASH) conference in December.
Roth Capital Partners and National Securities Corporation acted as joint book-running managers for the offering.
The securities were offered by Celator pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on February 12, 2014. The offering was made by means of the written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering was filed with the SEC on October 23, 2014. Electronic copies of the prospectus supplement and accompanying prospectus relating to the offering can be obtained through the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Roth Capital Partners, 888 San Clemente Drive, Newport Beach, CA 92660 Attention: Roth Equity Capital Markets, or via telephone at (800) 678-9147; or from National Securities Corporation, 410 Park Ave, 14th Floor, New York, NY 10022 Attention: Kim E. Addarich, via telephone at (212) 417-8164 or email at email@example.com.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, and shall not constitute an offer, solicitation or sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
CPX-351 (cytarabine:daunorubicin) Liposome for Injection represents a new approach to developing combinations of drugs in which drug molar ratios with synergistic anti-tumor activity are encapsulated in a drug delivery vehicle in order to maintain the desired ratio following administration. CPX-351 has been granted orphan drug status by the U.S. Food & Drug Administration (FDA) and the European Commission (EC) for the treatment of AML. Celator has conducted two randomized, controlled, Phase 2 studies with CPX-351. The first study was conducted in newly diagnosed elderly AML patients and the second study was conducted in patients with AML in first relapse. In both Phase 2 studies, treatment with CPX-351 resulted in significant improvements in response rates, 60-day mortality, and overall survival in the highest risk patients. The Leukemia & Lymphoma Society® has partnered with Celator in the development of CPX-351 starting in Phase 2 and continuing in Phase 3.
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 that 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. 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; and several programs exploring novel combinations of existing drugs, including molecularly targeted therapies.
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," "believe," "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 about the sufficiency of its capital to fund its activities into the second half of 2016, the expected timeline for its milestones in connection with its Phase 3 clinical study, its product pipeline, statements regarding the potential efficacy and therapeutic potential of CPX-351, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, and our expectations regarding our development plans for CPX-351 and our drug candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, capital market conditions, the uncertainties inherent in the conduct of future clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of Celator's drug candidates. 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, 2013 and other filings by Celator with the U.S. Securities and Exchange Commission.
Source:Celator Pharmaceuticals, Inc.